Trial Outcomes & Findings for Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE) (NCT NCT02847598)

Last Updated: 2023-11-07

Results Overview

An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). The 28 Joint Count includes assessment of swelling and tenderness in the shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and knees. The investigator counts how many of the 28 joints are swollen or tender at the given week.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

264 participants

Primary outcome timeframe

Baseline to Week 24

Results posted on

2023-11-07

Participant Flow

Participants were enrolled at 129 investigative sites in Argentina, Bulgaria, Colombia, Israel, Korea, Mexico, Philippines, Poland, Serbia, Taiwan, Thailand, and the United States from October 20, 2016 to November 18, 2019.

A total of 264 participants were enrolled in the study. The study had two parts, Part A (participants with Systemic lupus erythematosus (SLE) with active skin manifestations and joint involvement) and Part B (participants with active cutaneous lupus erythematosus (CLE), including discoid lupus erythematosus (DLE), with or without SLE).

Participant milestones

Participant milestones
Measure	Part A: Placebo Participants with systemic lupus erythematosus (SLE) with active skin manifestations and joint involvement received BIIB059 matching placebo subcutaneously (SC) every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part B: Placebo Participants with active cutaneous lupus erythematosus (CLE) with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.	Part B: BIIB059 50 mg Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.	Part B: BIIB059 150 mg Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.	Part B: BIIB059 450 mg Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Overall Study STARTED	56	6	6	64	33	26	25	48
Overall Study COMPLETED	51	6	6	60	30	23	23	44
Overall Study NOT COMPLETED	5	0	0	4	3	3	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Placebo Participants with systemic lupus erythematosus (SLE) with active skin manifestations and joint involvement received BIIB059 matching placebo subcutaneously (SC) every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part B: Placebo Participants with active cutaneous lupus erythematosus (CLE) with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.	Part B: BIIB059 50 mg Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.	Part B: BIIB059 150 mg Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.	Part B: BIIB059 450 mg Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Overall Study Adverse Event	0	0	0	0	0	1
Overall Study Consent withdrawn	2	4	3	2	1	3
Overall Study Death	3	0	0	0	0	0
Overall Study Lost to Follow-up	0	0	0	1	1	0

Baseline Characteristics

Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Placebo n=56 Participants Participants with systemic lupus erythematosus (SLE) with active skin manifestations and joint involvement received BIIB059 matching placebo subcutaneously (SC) every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=64 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part B: Placebo n=33 Participants Participants with active cutaneous lupus erythematosus (CLE) with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.	Part B: BIIB059 50 mg n=26 Participants Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.	Part B: BIIB059 150 mg n=25 Participants Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.	Part B: BIIB059 450 mg n=48 Participants Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.	Total n=264 Participants Total of all reporting groups
Age, Continuous	41.4 years STANDARD_DEVIATION 12.2 • n=93 Participants	35.0 years STANDARD_DEVIATION 14.4 • n=4 Participants	40.8 years STANDARD_DEVIATION 13.4 • n=27 Participants	40.3 years STANDARD_DEVIATION 11.4 • n=483 Participants	43.4 years STANDARD_DEVIATION 11.6 • n=36 Participants	43.3 years STANDARD_DEVIATION 15.3 • n=10 Participants	43.6 years STANDARD_DEVIATION 12.1 • n=115 Participants	44.0 years STANDARD_DEVIATION 12.6 • n=40 Participants	42.1 years STANDARD_DEVIATION 12.40 • n=8 Participants
Sex: Female, Male Female	49 Participants n=93 Participants	6 Participants n=4 Participants	5 Participants n=27 Participants	63 Participants n=483 Participants	30 Participants n=36 Participants	20 Participants n=10 Participants	20 Participants n=115 Participants	36 Participants n=40 Participants	229 Participants n=8 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	3 Participants n=36 Participants	6 Participants n=10 Participants	5 Participants n=115 Participants	12 Participants n=40 Participants	35 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	24 Participants n=483 Participants	3 Participants n=36 Participants	5 Participants n=10 Participants	1 Participants n=115 Participants	4 Participants n=40 Participants	65 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=93 Participants	4 Participants n=4 Participants	3 Participants n=27 Participants	20 Participants n=483 Participants	22 Participants n=36 Participants	14 Participants n=10 Participants	13 Participants n=115 Participants	34 Participants n=40 Participants	126 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	15 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	20 Participants n=483 Participants	8 Participants n=36 Participants	7 Participants n=10 Participants	11 Participants n=115 Participants	10 Participants n=40 Participants	73 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	8 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	5 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	13 Participants n=8 Participants
Race (NIH/OMB) Asian	13 Participants n=93 Participants	4 Participants n=4 Participants	2 Participants n=27 Participants	12 Participants n=483 Participants	14 Participants n=36 Participants	7 Participants n=10 Participants	6 Participants n=115 Participants	17 Participants n=40 Participants	75 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	6 Participants n=483 Participants	2 Participants n=36 Participants	5 Participants n=10 Participants	2 Participants n=115 Participants	5 Participants n=40 Participants	20 Participants n=8 Participants
Race (NIH/OMB) White	16 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	17 Participants n=483 Participants	9 Participants n=36 Participants	4 Participants n=10 Participants	6 Participants n=115 Participants	13 Participants n=40 Participants	67 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	19 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants	24 Participants n=483 Participants	8 Participants n=36 Participants	10 Participants n=10 Participants	11 Participants n=115 Participants	13 Participants n=40 Participants	89 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline to Week 24

Population: MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, "number of participants analyzed" signifies number of participants analyzed in this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=41 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=2 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=1 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=52 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24	-12.7 joints Standard Deviation 10.3	-9.0 joints Standard Deviation 5.7	-13.0 joints Standard Deviation NA Since only 1 participant was analyzed, standard deviation (SD) was not evaluated.	-14.5 joints Standard Deviation 8.7

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, "number of participants analyzed" signifies number of participants analyzed in this outcome measure.

The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a clinical tool that quantifies disease activity and damage in cutaneous lupus erythematosus (CLE). The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=31 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=23 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=24 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=42 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16	-15.03 percent change Standard Deviation 37.23	-35.52 percent change Standard Deviation 33.35	-47.11 percent change Standard Deviation 34.10	-41.66 percent change Standard Deviation 37.33

SECONDARY outcome

Timeframe: Week 24

Population: MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, "number of participants analyzed" signifies those with baseline CLASI-A \>=8 following protocol amendment.

CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Week 24. The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=38 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=39 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A : Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24	42.11 percentage of participants	50 percentage of participants	16.67 percentage of participants	64.10 percentage of participants

SECONDARY outcome

Timeframe: Week 12, Week 16

Population: MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, "number analyzed" signifies number of participants analyzed at specific timepoint.

CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Weeks 12 and 16. The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=33 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=26 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=25 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=48 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16 Week 12	12.12 percentage of participants	38.46 percentage of participants	48.00 percentage of participants	37.50 percentage of participants
Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16 Week 16	21.88 percentage of participants	38.46 percentage of participants	44.00 percentage of participants	46.51 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12, 16 and 24

The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=38 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=39 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24 Change at Week 16	-42.55 percent change Standard Deviation 32.46	-41.76 percent change Standard Deviation 19.72	-6.19 percent change Standard Deviation 21.31	-50.20 percent change Standard Deviation 38.32
Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24 Change at Week 24	-45.40 percent change Standard Deviation 34.38	-58.61 percent change Standard Deviation 35.16	-17.92 percent change Standard Deviation 31.16	-60.59 percent change Standard Deviation 37.36
Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24 Change at Week 12	-36.63 percent change Standard Deviation 28.23	-29.32 percent change Standard Deviation 14.66	-8.39 percent change Standard Deviation 34.48	-44.36 percent change Standard Deviation 39.69

SECONDARY outcome

Timeframe: Baseline, Week 12

Outcome measures

Outcome measures
Measure	Part A: Placebo n=32 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=23 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=24 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=44 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12	-10.73 percent change Standard Deviation 34.41	-38.72 percent change Standard Deviation 32.99	-47.82 percent change Standard Deviation 31.80	-35.25 percent change Standard Deviation 35.77

SECONDARY outcome

Timeframe: Week 24

Outcome measures

Outcome measures
Measure	Part A: Placebo n=38 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=39 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A: Percentage of Participants With a >=4-point Reduction From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24	57.89 percentage of participants	83.66 percentage of participants	16.67 percentage of participants	71.79 percentage of participants

SECONDARY outcome

Timeframe: Week 12, Week 16

Population: MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, "number of analyzed" signifies number of participants analyzed at specific timepoint.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=33 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=26 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=25 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=48 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 Week 12	33.33 percentage of participants	50.00 percentage of participants	76.00 percentage of participants	47.92 percentage of participants
Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 Week 16	37.50 percentage of participants	46.15 percentage of participants	72.00 percentage of participants	55.81 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Outcome measures

Outcome measures
Measure	Part A: Placebo n=38 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=39 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24	34.21 percentage of participants	66.67 percentage of participants	16.67 percentage of participants	56.41 percentage of participants

SECONDARY outcome

Timeframe: Week 12, Week 16

Population: MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, "number analyzed" signifies number of participants analyzed at specific timepoint.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=33 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=26 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=25 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=48 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 Week 12	18.18 percentage of participants	38.46 percentage of participants	40.00 percentage of participants	33.33 percentage of participants
Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 Week 16	21.88 percentage of participants	30.77 percentage of participants	48.00 percentage of participants	41.86 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol).

An SRI-4 at Week 24 was a categorical response variable (Yes/No) incorporating the following criteria for achievement of responder status (i.e., all criteria must have been met to achieve responder status): A reduction from baseline of ≥4 points in SLEDAI-2K, No new organ system affected, as defined by no new BILAG-2004 Grade A and no more than 1 new BILAG-2004 Grade B, No worsening from baseline in participant's lupus disease activity, defined by a \<1-point increase in the PGA (VAS) \[on a scale of 0 to 10\],No changes to protocol-specified medication rules,as follows (all criteria were required to be met): No initiation or increase of SLE standard of care therapy or other disallowed concomitant therapy; Concomitant corticosteroid dosage at Week 24 to be ≤10 mg/day;Concomitant corticosteroid dosage at Week 24 was no more than at Day 1;No increase in corticosteroid dose between Weeks 17 and 24. The percentage of participants who had responded to each of the 4 criteria was also reported.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=56 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=64 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A: Percentage of Participants Achieving a Systemic Lupus Erythematosus (SLE) Responder Index >=4 (SRI-4) at Week 24	28.57 percentage of participants	33.33 percentage of participants	16.67 percentage of participants	56.25 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 24

The SLEDAI-2K is a reliable, valid, simple, 1-page activity index that measures disease activity and records features of active lupus as present or not. It uses a weighted checklist to assign a numeric score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 28 days. Each symptom present is assigned between 1 and up to 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms), where higher scores representing increased disease activity.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=50 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=3 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=59 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score at Week 24	-2.1 score on a scale Standard Deviation 3.3	-3.0 score on a scale Standard Deviation 4.7	-1.3 score on a scale Standard Deviation 2.4	-4.4 score on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: Week 24

Population: MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol).

No new organ system affected, as defined by no new British Isles Lupus Activity Group (BILAG)-2004 A and no more than one new BILAG-2004 B. The BILAG-2004 index categorizes disease activity in each organ system into five different levels from A to E. Grade A represents very active disease, Grade B represents moderate disease activity, Grade C indicates mild stable disease, and grade D implies no disease activity, but suggests the organ system had previously been affected. Grade E indicates no current or previous disease activity. A score is applied to each grade of each organ system using coding scheme of A=12, B=8, C=1, and D/E=0 and is summarized as a total score ranging 0-108. Higher scores indicate more severe disease activity.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=56 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=64 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A: Percentage of Participants With no New Organ System Affected at Week 24	82.14 percentage of participants	100.00 percentage of participants	50.00 percentage of participants	85.94 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 24

The PGA is used to quantify disease activity and is measured using an anchored VAS. The PGA asks the Investigator to assess the participants current disease activity from a score of 0 (none) to 3 (severe), where higher score means severe SLE disease activity.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=49 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=57 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A: Change From Baseline in Physician's Global Assessment (PGA) of SLE Visual Analog Scale (VAS) Score at Week 24	-2.46 score on a scale Standard Deviation 2.13	-2.05 score on a scale Standard Deviation 1.18	-0.12 score on a scale Standard Deviation 1.48	-2.45 score on a scale Standard Deviation 2.33

SECONDARY outcome

Timeframe: Baseline up to Week 36

Population: Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received.

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: Results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=56 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=64 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	38 Participants	3 Participants	6 Participants	36 Participants
Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	6 Participants	0 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 28

Population: Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=33 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=26 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=25 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=48 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	22 Participants	18 Participants	15 Participants	38 Participants
Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	3 Participants	1 Participants	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 36

Population: Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=56 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=64 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 28

Population: Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=33 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=26 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=25 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=48 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part B: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 36

Population: Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=56 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=64 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A: Number of Participants With Clinically Significant Vital Sign Abnormalities	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 28

Population: Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=33 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=26 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=25 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=48 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 36

Population: Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=56 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=5 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=64 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 28

Population: Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=33 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=26 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=25 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=48 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part B: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=56 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=63 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A: Number of Participants With Positive BIIB059 Antibodies	1 Participants	0 Participants	0 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=32 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=26 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=25 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=48 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part B: Number of Participants With Positive BIIB059 Antibodies	0 Participants	5 Participants	4 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, "number analyzed" signifies number of participants analyzed at specific timepoint.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=56 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=64 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels Immunoglobulin A (IgA): Baseline	3.350 grams per Liter (g/L) Standard Deviation 1.862	3.610 grams per Liter (g/L) Standard Deviation 0.730	4.080 grams per Liter (g/L) Standard Deviation 1.537	3.116 grams per Liter (g/L) Standard Deviation 1.682
Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels IgA: Change at Week 16	0.033 grams per Liter (g/L) Standard Deviation 0.529	—	—	-0.006 grams per Liter (g/L) Standard Deviation 0.305
Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels IgA: Change at Week 24	-0.093 grams per Liter (g/L) Standard Deviation 0.704	-0.433 grams per Liter (g/L) Standard Deviation 1.188	-0.057 grams per Liter (g/L) Standard Deviation 0.966	0.012 grams per Liter (g/L) Standard Deviation 0.505
Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels Immunoglobulin G (IgG): Baseline	14.423 grams per Liter (g/L) Standard Deviation 4.927	15.723 grams per Liter (g/L) Standard Deviation 1.584	17.620 grams per Liter (g/L) Standard Deviation 5.502	14.792 grams per Liter (g/L) Standard Deviation 6.778
Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels IgG: Change at Week 16	1.057 grams per Liter (g/L) Standard Deviation 2.832	—	—	0.233 grams per Liter (g/L) Standard Deviation 2.478
Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels IgG: Change at Week 24	0.874 grams per Liter (g/L) Standard Deviation 3.376	-0.468 grams per Liter (g/L) Standard Deviation 1.333	-0.790 grams per Liter (g/L) Standard Deviation 4.967	0.758 grams per Liter (g/L) Standard Deviation 2.599
Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels Immunoglobulin M (IgM): Baseline	1.046 grams per Liter (g/L) Standard Deviation 0.657	1.065 grams per Liter (g/L) Standard Deviation 0.507	1.242 grams per Liter (g/L) Standard Deviation 0.718	1.106 grams per Liter (g/L) Standard Deviation 0.953
Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels IgM: Change at Week 16	0.004 grams per Liter (g/L) Standard Deviation 0.137	—	—	-0.065 grams per Liter (g/L) Standard Deviation 0.294
Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels IgM: Change at Week 24	-0.003 grams per Liter (g/L) Standard Deviation 0.191	-0.050 grams per Liter (g/L) Standard Deviation 0.113	-0.150 grams per Liter (g/L) Standard Deviation 0.160	-0.072 grams per Liter (g/L) Standard Deviation 0.409

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, "number analyzed" signifies number of participants analyzed at specific timepoint.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=33 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=26 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=25 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=48 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels IgG: Baseline	13.480 g/L Standard Deviation 4.193	14.087 g/L Standard Deviation 4.285	13.700 g/L Standard Deviation 5.397	14.874 g/L Standard Deviation 5.904
Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels IgG: Change at Week 12	0.120 g/L Standard Deviation 0.662	—	—	-1.961 g/L Standard Deviation 4.312
Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels IgG: Change at Week 16	0.450 g/L Standard Deviation 3.366	-0.776 g/L Standard Deviation 1.405	-0.084 g/L Standard Deviation 3.975	-0.064 g/L Standard Deviation 1.375
Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels IgA: Baseline	3.341 g/L Standard Deviation 1.113	3.873 g/L Standard Deviation 1.663	2.900 g/L Standard Deviation 1.705	3.061 g/L Standard Deviation 1.413
Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels IgA: Change at Week 12	-0.029 g/L Standard Deviation 0.249	—	—	-0.304 g/L Standard Deviation 0.711
Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels IgA: Change at Week 16	-0.045 g/L Standard Deviation 0.432	-0.117 g/L Standard Deviation 0.356	-0.016 g/L Standard Deviation 0.376	-0.076 g/L Standard Deviation 0.254
Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels IgM: Baseline	0.978 g/L Standard Deviation 0.553	0.880 g/L Standard Deviation 0.563	1.095 g/L Standard Deviation 0.656	0.993 g/L Standard Deviation 0.757
Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels IgM: Change at Week 12	-0.009 g/L Standard Deviation 0.061	—	—	-0.028 g/L Standard Deviation 0.096
Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels IgM: Change at Week 16	-0.016 g/L Standard Deviation 0.125	-0.072 g/L Standard Deviation 0.119	-0.045 g/L Standard Deviation 0.217	-0.035 g/L Standard Deviation 0.150

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, "overall number of participants analyzed" signifies number of participants analyzed in this outcome measure and "number analyzed" signifies number of participants analyzed at specific timepoint.

Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) were analyzed, including 23 types of serotypes (sero). AB = Antibody.

Outcome measures

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, "overall number of participants analyzed" signifies number of participants analyzed in this outcome measure and "number analyzed" signifies number of participants analyzed at specific timepoint.

Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) were analyzed, including 23 types of serotypes (sero). AB = Antibody.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=10 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=1 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=21 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 15B IgG AB: Change at Week 12	0.209 mg/L Standard Deviation 0.2118	—	—	0.624 mg/L Standard Deviation 1.4874
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 17F IgG AB: Baseline	16.0005 mg/L Standard Deviation 15.82427	17.4500 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	6.8752 mg/L Standard Deviation 9.02378
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 19F IgG AB: Baseline	4.1040 mg/L Standard Deviation 5.50276	2.0500 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	3.3800 mg/L Standard Deviation 3.26583
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 1 IgG AB: Baseline	3.538 mg/L Standard Deviation 6.0374	0.210 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	1.930 mg/L Standard Deviation 2.6639
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 1 IgG AB: Change at Week 12	4.193 mg/L Standard Deviation 9.8131	—	—	0.116 mg/L Standard Deviation 0.4689
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 2 IgG AB: Baseline	4.7775 mg/L Standard Deviation 10.24616	0.9900 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	3.9669 mg/L Standard Deviation 8.68701
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 2 IgG AB: Change at Week 12	-0.4586 mg/L Standard Deviation 0.72158	—	—	-0.4734 mg/L Standard Deviation 4.04649
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 3 IgG AB: Baseline	3.881 mg/L Standard Deviation 7.0122	0.400 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	1.133 mg/L Standard Deviation 1.0457
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 3 IgG AB: Change at Week 12	-1.886 mg/L Standard Deviation 5.4670	—	—	0.307 mg/L Standard Deviation 0.7307
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 4 IgG AB: Baseline	3.6185 mg/L Standard Deviation 8.92846	0.1000 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	1.2376 mg/L Standard Deviation 1.90643
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 4 IgG AB: Change at Week 12	0.0571 mg/L Standard Deviation 0.20934	—	—	0.0450 mg/L Standard Deviation 0.63581
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 5 IgG AB: Baseline	7.2845 mg/L Standard Deviation 10.00019	3.3500 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	5.0124 mg/L Standard Deviation 5.83330
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 5 IgG AB: Change at Week 12	4.4443 mg/L Standard Deviation 7.54015	—	—	3.4794 mg/L Standard Deviation 5.30014
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 6B IgG AB: Baseline	10.7965 mg/L Standard Deviation 29.02953	0.3600 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	2.9210 mg/L Standard Deviation 4.10508
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 6B IgG AB: Change at Week 12	0.2943 mg/L Standard Deviation 0.63629	—	—	0.2738 mg/L Standard Deviation 1.49780
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 7F IgG AB: Baseline	2.482 mg/L Standard Deviation 3.0844	0.660 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	3.030 mg/L Standard Deviation 2.6854
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 7F IgG AB: Change at Week 12	4.399 mg/L Standard Deviation 10.6094	—	—	0.796 mg/L Standard Deviation 1.8650
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 8 IgG AB: Baseline	3.6820 mg/L Standard Deviation 3.59284	0.2300 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	2.6629 mg/L Standard Deviation 3.61369
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 8 IgG AB: Change at Week 12	1.5329 mg/L Standard Deviation 4.51498	—	—	0.5931 mg/L Standard Deviation 1.32472
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 9N IgG AB: Baseline	4.1090 mg/L Standard Deviation 6.77642	0.1300 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	2.0848 mg/L Standard Deviation 2.59536
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 9N IgG AB: Change at Week 12	3.3407 mg/L Standard Deviation 8.56070	—	—	0.5875 mg/L Standard Deviation 1.62657
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 9V IgG AB: Baseline	1.104 mg/L Standard Deviation 1.2697	0.070 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	1.520 mg/L Standard Deviation 2.4346
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 9V IgG AB: Change at Week 12	-0.001 mg/L Standard Deviation 0.3491	—	—	-0.181 mg/L Standard Deviation 0.9893
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 10A IgG AB: Baseline	6.760 mg/L Standard Deviation 10.6571	2.140 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	6.600 mg/L Standard Deviation 9.0014
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 10A IgG AB: Change at Week 12	1.833 mg/L Standard Deviation 3.0611	—	—	4.696 mg/L Standard Deviation 13.8354
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 11A IgG AB: Baseline	2.1860 mg/L Standard Deviation 2.85529	0.3500 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	3.5831 mg/L Standard Deviation 4.19998
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 11A IgG AB: Change at Week 12	0.6293 mg/L Standard Deviation 3.04077	—	—	0.6431 mg/L Standard Deviation 1.74757
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 12F IgG AB: Baseline	2.1680 mg/L Standard Deviation 4.29056	0.2700 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	1.2424 mg/L Standard Deviation 1.21257
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 12F IgG AB: Change at Week 12	1.1429 mg/L Standard Deviation 2.54387	—	—	0.3638 mg/L Standard Deviation 0.72331
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 14 IgG AB: Baseline	5.6435 mg/L Standard Deviation 7.09870	8.9000 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	11.0210 mg/L Standard Deviation 12.99039
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 14 IgG AB: Change at Week 12	1.3686 mg/L Standard Deviation 5.66545	—	—	-1.0319 mg/L Standard Deviation 3.43469
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 15B IgG AB: Baseline	4.717 mg/L Standard Deviation 9.7429	1.430 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	3.410 mg/L Standard Deviation 3.5117
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 17F IgG AB: Change at Week 12	-2.0357 mg/L Standard Deviation 4.29278	—	—	1.4531 mg/L Standard Deviation 3.87924
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 18C IgG AB: Baseline	4.083 mg/L Standard Deviation 6.6047	0.140 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	5.630 mg/L Standard Deviation 7.8627
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 18C IgG AB: Change at Week 12	8.439 mg/L Standard Deviation 21.2741	—	—	0.077 mg/L Standard Deviation 1.0131
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 19A IgG AB: Baseline	24.5485 mg/L Standard Deviation 44.24043	13.7700 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	16.5624 mg/L Standard Deviation 15.27894
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 19A IgG AB: Change at Week 12	3.4457 mg/L Standard Deviation 6.31401	—	—	5.3575 mg/L Standard Deviation 8.84223
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 19F IgG AB: Change at Week 12	2.3893 mg/L Standard Deviation 4.24918	—	—	1.2275 mg/L Standard Deviation 2.05550
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 20 IgG AB: Baseline	11.5305 mg/L Standard Deviation 18.12761	0.7900 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	8.2971 mg/L Standard Deviation 8.28676
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 20 IgG AB: Change at Week 12	-0.2271 mg/L Standard Deviation 5.08362	—	—	-1.6638 mg/L Standard Deviation 6.48421
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 22F IgG AB: Baseline	5.9930 mg/L Standard Deviation 10.47744	0.6700 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	3.8002 mg/L Standard Deviation 6.40547
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 22F IgG AB: Change at Week 12	-1.8500 mg/L Standard Deviation 4.69494	—	—	1.8431 mg/L Standard Deviation 5.04651
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 23F IgG AB: Baseline	1.6980 mg/L Standard Deviation 2.81930	0.5600 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	1.9957 mg/L Standard Deviation 2.72717
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 23F IgG AB: Change at Week 12	1.9964 mg/L Standard Deviation 5.10312	—	—	0.2775 mg/L Standard Deviation 0.60481
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 33F IgG AB: Baseline	5.500 mg/L Standard Deviation 8.3404	0.220 mg/L Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	4.245 mg/L Standard Deviation 4.6106
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 Sero 33F IgG AB: Change at Week 12	-0.281 mg/L Standard Deviation 0.4481	—	—	0.203 mg/L Standard Deviation 1.4614

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Safety population included all randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, "overall number of participants analyzed" signifies number of participants analyzed in this outcome measure and "number analyzed" signifies number of participants analyzed at specific timepoint.

Vaccine-related immunoglobulin titers for tetanus and diphtheria were analyzed using international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Part A: Placebo n=54 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=62 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 C. tetani IgG Antibody: Baseline	2.46 IU/mL Standard Deviation 2.532	1.73 IU/mL Standard Deviation 1.660	2.52 IU/mL Standard Deviation 2.219	3.30 IU/mL Standard Deviation 3.674
Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 C. tetani IgG Antibody: Change at Week 24	-0.07 IU/mL Standard Deviation 1.975	0.07 IU/mL Standard Deviation 0.437	1.07 IU/mL Standard Deviation 2.890	-0.70 IU/mL Standard Deviation 2.398
Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 Diphtheria IgG Antibody: Baseline	0.33 IU/mL Standard Deviation 0.511	0.10 IU/mL Standard Deviation 0.089	0.17 IU/mL Standard Deviation 0.163	0.33 IU/mL Standard Deviation 0.444
Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 Diphtheria IgG Antibody: Change at Week 24	-0.06 IU/mL Standard Deviation 0.266	-0.03 IU/mL Standard Deviation 0.082	0.07 IU/mL Standard Deviation 0.163	-0.07 IU/mL Standard Deviation 0.340

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Safety population included all randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, "overall number of participants analyzed" signifies number of participants analyzed in this outcome measure and "number analyzed" signifies number of participants analyzed at specific timepoint.

Vaccine-related immunoglobulin titers for tetanus and diphtheria were analyzed.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=10 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=1 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=21 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12 C. tetani IgG Antibody: Baseline	4.41 IU/mL Standard Deviation 3.469	3.00 IU/mL Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	5.04 IU/mL Standard Deviation 2.910
Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12 C. tetani IgG Antibody: Change at Week 12	-0.61 IU/mL Standard Deviation 1.178	—	—	1.20 IU/mL Standard Deviation 6.948
Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12 Diphtheria IgG Antibody: Baseline	0.46 IU/mL Standard Deviation 0.465	0.10 IU/mL Standard Deviation NA Since only 1 participant was analyzed, SD was not evaluated.	—	0.74 IU/mL Standard Deviation 1.027
Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12 Diphtheria IgG Antibody: Change at Week 12	-0.01 IU/mL Standard Deviation 0.146	—	—	0.06 IU/mL Standard Deviation 0.875

SECONDARY outcome

Timeframe: Baseline up to Week 24

Outcome measures

Outcome measures
Measure	Part A: Placebo n=56 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=64 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels IgA: Change at Week 16	1.50 percent change Standard Deviation 11.91	—	—	-0.53 percent change Standard Deviation 9.22
Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels IgA: Change at Week 24	-1.51 percent change Standard Deviation 18.94	-15.55 percent change Standard Deviation 41.08	-0.10 percent change Standard Deviation 18.22	-0.48 percent change Standard Deviation 12.94
Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels IgG: Change at Week 16	7.30 percent change Standard Deviation 16.58	—	—	2.63 percent change Standard Deviation 15.23
Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels IgG: Change at Week 24	6.86 percent change Standard Deviation 19.20	-2.53 percent change Standard Deviation 8.52	-5.88 percent change Standard Deviation 23.39	6.07 percent change Standard Deviation 16.44
Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels IgM: Change at Week 16	0.96 percent change Standard Deviation 11.71	—	—	-0.73 percent change Standard Deviation 40.24
Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels IgM: Change at Week 24	1.86 percent change Standard Deviation 19.22	-6.73 percent change Standard Deviation 12.57	-14.99 percent change Standard Deviation 11.74	0.87 percent change Standard Deviation 45.16

SECONDARY outcome

Timeframe: Baseline up to Week 16

Outcome measures

Outcome measures
Measure	Part A: Placebo n=33 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=26 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=25 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=48 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels Ig M: Change at Week 16	-3.62 percent change Standard Deviation 10.84	-7.60 percent change Standard Deviation 12.86	-1.25 percent change Standard Deviation 22.27	-0.57 percent change Standard Deviation 11.85
Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels Ig M: Change at Week 12	-1.25 percent change Standard Deviation 4.98	—	—	-1.22 percent change Standard Deviation 18.25
Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels Ig A: Change at Week 12	-1.45 percent change Standard Deviation 7.14	—	—	-5.11 percent change Standard Deviation 14.44
Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels Ig A: Change at Week 16	-1.32 percent change Standard Deviation 12.92	-1.48 percent change Standard Deviation 10.13	0.19 percent change Standard Deviation 14.22	-2.98 percent change Standard Deviation 7.64
Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels Ig G: Change at Week 12	0.63 percent change Standard Deviation 5.76	—	—	-8.40 percent change Standard Deviation 18.97
Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels Ig G: Change at Week 16	2.48 percent change Standard Deviation 19.59	-3.84 percent change Standard Deviation 11.14	1.05 percent change Standard Deviation 18.28	-0.39 percent change Standard Deviation 9.81

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, "overall number of participants analyzed" signifies number of participants analyzed in this outcome measure and "number analyzed" signifies number of participants analyzed at specific timepoint.

Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) including 23 types of serotypes (sero), tetanus and diphtheria were analyzed. AB = Antibody

Outcome measures

Outcome measures
Measure	Part A: Placebo n=54 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=63 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 15B IgG AB: Change at Week 24	11.206 percent change Standard Deviation 116.7649	17.353 percent change Standard Deviation 66.5358	-5.380 percent change Standard Deviation 47.4598	69.305 percent change Standard Deviation 570.5864
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 8 IgG AB: Change at Week 24	13.540 percent change Standard Deviation 64.9487	-14.917 percent change Standard Deviation 72.2397	-19.919 percent change Standard Deviation 55.3947	13.552 percent change Standard Deviation 54.9741
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 9V IgG AB: Change at Week 24	32.983 percent change Standard Deviation 138.1448	-3.399 percent change Standard Deviation 47.7558	-13.591 percent change Standard Deviation 34.6936	56.445 percent change Standard Deviation 189.5817
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 12F IgG AB: Change at Week 24	-4.445 percent change Standard Deviation 72.6724	-5.463 percent change Standard Deviation 105.9311	-41.416 percent change Standard Deviation 37.8396	-11.447 percent change Standard Deviation 58.0173
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 14 IgG AB: Change at Week 24	-3.087 percent change Standard Deviation 55.1562	-31.375 percent change Standard Deviation 69.5715	2.213 percent change Standard Deviation 83.1715	20.278 percent change Standard Deviation 136.8606
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 19A IgG AB: Change at Week 24	21.433 percent change Standard Deviation 55.0044	44.814 percent change Standard Deviation 73.1928	-16.275 percent change Standard Deviation 73.1979	32.146 percent change Standard Deviation 64.1971
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 19F IgG AB: Change at Week 24	54.691 percent change Standard Deviation 114.1882	5.412 percent change Standard Deviation 83.2939	-20.778 percent change Standard Deviation 54.8585	101.397 percent change Standard Deviation 221.3435
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 1 IgG AB: Change at Week 24	53.629 percent change Standard Deviation 206.5979	2.996 percent change Standard Deviation 56.3607	-10.403 percent change Standard Deviation 40.9969	159.298 percent change Standard Deviation 788.0577
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 2 IgG AB: Change at Week 24	-2.263 percent change Standard Deviation 52.3214	17.857 percent change Standard Deviation 64.1746	-26.089 percent change Standard Deviation 35.2991	2.207 percent change Standard Deviation 57.5136
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 3 IgG AB: Change at Week 24	-10.854 percent change Standard Deviation 34.9399	530.405 percent change Standard Deviation 1313.1947	16.282 percent change Standard Deviation 89.2804	51.000 percent change Standard Deviation 205.2211
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 4 IgG AB: Change at Week 24	-8.039 percent change Standard Deviation 43.2246	-15.385 percent change Standard Deviation 70.4542	-26.435 percent change Standard Deviation 50.4316	26.481 percent change Standard Deviation 143.2057
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 5 IgG AB: Change at Week 24	13.293 percent change Standard Deviation 54.1115	81.053 percent change Standard Deviation 156.0747	2.937 percent change Standard Deviation 88.0683	23.064 percent change Standard Deviation 57.0094
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 6B IgG AB: Change at Week 24	-8.215 percent change Standard Deviation 36.4547	-7.761 percent change Standard Deviation 68.3190	-40.573 percent change Standard Deviation 28.7097	34.204 percent change Standard Deviation 179.4443
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 7F IgG AB: Change at Week 24	-7.560 percent change Standard Deviation 54.4647	1.928 percent change Standard Deviation 90.5777	-27.272 percent change Standard Deviation 30.2249	19.827 percent change Standard Deviation 120.4336
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 9N IgG AB: Change at Week 24	13.302 percent change Standard Deviation 108.1678	22.663 percent change Standard Deviation 111.5069	2.985 percent change Standard Deviation 42.6740	13.703 percent change Standard Deviation 137.0620
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 10A IgG AB: Change at Week 24	19.729 percent change Standard Deviation 111.4367	101.031 percent change Standard Deviation 168.5588	11.364 percent change Standard Deviation 51.7417	24.321 percent change Standard Deviation 83.4616
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 11A IgG AB: Change at Week 24	51.134 percent change Standard Deviation 146.8640	-16.656 percent change Standard Deviation 93.1140	14.976 percent change Standard Deviation 131.8861	18.956 percent change Standard Deviation 90.1198
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 17F IgG AB: Change at Week 24	20.238 percent change Standard Deviation 90.3348	1.009 percent change Standard Deviation 53.3534	-29.346 percent change Standard Deviation 51.5854	51.187 percent change Standard Deviation 152.3694
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 18C IgG AB: Change at Week 24	14.720 percent change Standard Deviation 64.9702	-14.827 percent change Standard Deviation 57.5927	-30.608 percent change Standard Deviation 35.7004	43.454 percent change Standard Deviation 218.7604
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 20 IgG AB: Change at Week 24	35.202 percent change Standard Deviation 90.9529	-37.641 percent change Standard Deviation 33.1824	-53.328 percent change Standard Deviation 21.6352	75.407 percent change Standard Deviation 168.3388
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 22F IgG AB: Change at Week 24	11.419 percent change Standard Deviation 127.0639	23.828 percent change Standard Deviation 108.3336	-27.150 percent change Standard Deviation 51.7944	20.048 percent change Standard Deviation 139.8965
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 23F IgG AB: Change at Week 24	0.215 percent change Standard Deviation 50.6348	18.204 percent change Standard Deviation 57.8187	35.862 percent change Standard Deviation 55.9954	22.329 percent change Standard Deviation 156.8530
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Sero 33F IgG AB: Change at Week 24	2.245 percent change Standard Deviation 65.7260	-3.348 percent change Standard Deviation 64.8128	-47.069 percent change Standard Deviation 32.3779	23.533 percent change Standard Deviation 102.5771
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 C.tetani IgG Antibody: Change at Week24	19.517 percent change Standard Deviation 194.1378	39.032 percent change Standard Deviation 83.7958	29.887 percent change Standard Deviation 80.9696	-11.895 percent change Standard Deviation 48.3260
Part A: Percent Change From Baseline in Vaccine Titers at Week 24 Diphtheria IgG Antibody: Change at Week 24	15.310 percent change Standard Deviation 141.4934	-50.000 percent change Standard Deviation 70.7107	77.083 percent change Standard Deviation 156.8461	-8.842 percent change Standard Deviation 52.9312

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, "overall number of participants analyzed" signifies number of participants analyzed in this outcome measure and "number analyzed" signifies number of participants analyzed at specific timepoint.

Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) including 23 types of serotypes (sero), tetanus and diphtheria were analyzed. AB = Antibody.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=10 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=1 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=21 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 14 IgG AB: Change at Week 12	77.551 percent change Standard Deviation 191.9769	—	—	18.059 percent change Standard Deviation 75.7757
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 22F IgG AB: Change at Week 12	-14.748 percent change Standard Deviation 45.9399	—	—	38.974 percent change Standard Deviation 83.4963
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 23F IgG AB: Change at Week 12	52.210 percent change Standard Deviation 75.6486	—	—	16.859 percent change Standard Deviation 40.1773
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 33F IgG AB: Change at Week 12	0.600 percent change Standard Deviation 31.4400	—	—	26.241 percent change Standard Deviation 66.5051
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 1 IgG AB: Change at Week 12	16.835 percent change Standard Deviation 59.1269	—	—	4.257 percent change Standard Deviation 67.8533
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 2 IgG AB: Change at Week 12	-20.725 percent change Standard Deviation 23.3306	—	—	15.437 percent change Standard Deviation 65.9854
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 3 IgG AB: Change at Week 12	-3.370 percent change Standard Deviation 38.0473	—	—	40.604 percent change Standard Deviation 72.3862
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 4 IgG AB: Change at Week 12	6.349 percent change Standard Deviation 31.2778	—	—	32.033 percent change Standard Deviation 125.5527
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 5 IgG AB: Change at Week 12	39.578 percent change Standard Deviation 34.1628	—	—	68.850 percent change Standard Deviation 127.9989
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 6B IgG AB: Change at Week 12	11.800 percent change Standard Deviation 36.9732	—	—	43.759 percent change Standard Deviation 97.2095
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 7F IgG AB: Change at Week 12	67.784 percent change Standard Deviation 90.5075	—	—	25.297 percent change Standard Deviation 48.3430
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 8 IgG AB: Change at Week 12	28.981 percent change Standard Deviation 76.3568	—	—	41.622 percent change Standard Deviation 84.8290
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 9N IgG AB: Change at Week 12	18.274 percent change Standard Deviation 61.3305	—	—	19.616 percent change Standard Deviation 74.2945
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 9V IgG AB: Change at Week 12	-7.707 percent change Standard Deviation 27.1098	—	—	-0.573 percent change Standard Deviation 35.9671
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 10A IgG AB: Change at Week 12	62.824 percent change Standard Deviation 94.6871	—	—	60.437 percent change Standard Deviation 145.3385
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 11A IgG AB: Change at Week 12	12.392 percent change Standard Deviation 69.6069	—	—	29.295 percent change Standard Deviation 118.2639
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 12F IgG AB: Change at Week 12	21.768 percent change Standard Deviation 44.1688	—	—	62.768 percent change Standard Deviation 118.4103
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 15B IgG AB: Change at Week 12	14.160 percent change Standard Deviation 16.8040	—	—	27.188 percent change Standard Deviation 56.4211
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 17F IgG AB: Change at Week 12	-14.128 percent change Standard Deviation 20.3094	—	—	19.712 percent change Standard Deviation 69.9092
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 18C IgG AB: Change at Week 12	36.970 percent change Standard Deviation 99.7771	—	—	8.882 percent change Standard Deviation 41.3781
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 19A IgG AB: Change at Week 12	15.179 percent change Standard Deviation 28.0371	—	—	44.140 percent change Standard Deviation 113.5780
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 19F IgG AB: Change at Week 12	54.773 percent change Standard Deviation 49.4505	—	—	46.995 percent change Standard Deviation 90.7514
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Sero 20 IgG AB: Change at Week 12	1.131 percent change Standard Deviation 51.4091	—	—	0.714 percent change Standard Deviation 49.6361
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 C. tetani IgG Antibody: Change at Week 12	-6.387 percent change Standard Deviation 18.2069	—	—	27.872 percent change Standard Deviation 128.3927
Part B: Percent Change From Baseline in Vaccine Titers at Week 12 Diphtheria IgG Antibody: Change at Week 12	0.000 percent change Standard Deviation 34.0588	—	—	28.845 percent change Standard Deviation 132.2208

SECONDARY outcome

Timeframe: Part A: pre-dose on Days 1, 29, 85 and 113 and post-dose on Days 1, 8, 29, 85, 169, 197 and 253

Population: The PK population included the safety participants who had at least 1 PK concentration measurement. The number analyzed is the number of participants with data available for analysis at the specified time point. The number analyzed is the number of participants with data available for analysis at the specified time point.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=6 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=64 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A: Serum Concentration of BIIB059 Day 1: Pre-dose	0.0 nanogram per milliliter (ng/mL) Standard Deviation 0.0	0.0 nanogram per milliliter (ng/mL) Standard Deviation 0.0	0.0 nanogram per milliliter (ng/mL) Standard Deviation 0.0	—
Part A: Serum Concentration of BIIB059 Day 1: Post-dose	0.7 nanogram per milliliter (ng/mL) Standard Deviation 0.6	2.1 nanogram per milliliter (ng/mL) Standard Deviation 1.3	1.9 nanogram per milliliter (ng/mL) Standard Deviation 2.1	—
Part A: Serum Concentration of BIIB059 Day 8	5.5 nanogram per milliliter (ng/mL) Standard Deviation 2.0	17.1 nanogram per milliliter (ng/mL) Standard Deviation 4.1	45.5 nanogram per milliliter (ng/mL) Standard Deviation 16.5	—
Part A: Serum Concentration of BIIB059 Day 29: Pre-dose	7.0 nanogram per milliliter (ng/mL) Standard Deviation 3.3	23.7 nanogram per milliliter (ng/mL) Standard Deviation 7.2	53.6 nanogram per milliliter (ng/mL) Standard Deviation 19.7	—
Part A: Serum Concentration of BIIB059 Day 29: Post-dose	7.9 nanogram per milliliter (ng/mL) Standard Deviation 4.2	25.9 nanogram per milliliter (ng/mL) Standard Deviation 5.6	52.5 nanogram per milliliter (ng/mL) Standard Deviation 20.5	—
Part A: Serum Concentration of BIIB059 Day 85: Pre-dose	3.9 nanogram per milliliter (ng/mL) Standard Deviation 1.6	12.7 nanogram per milliliter (ng/mL) Standard Deviation 3.7	34.7 nanogram per milliliter (ng/mL) Standard Deviation 19.1	—
Part A: Serum Concentration of BIIB059 Day 85: Post-dose	—	—	36.1 nanogram per milliliter (ng/mL) Standard Deviation 23.2	—
Part A: Serum Concentration of BIIB059 Day 113: Pre-dose	3.4 nanogram per milliliter (ng/mL) Standard Deviation 1.5	11.3 nanogram per milliliter (ng/mL) Standard Deviation 5.2	34.6 nanogram per milliliter (ng/mL) Standard Deviation 20.8	—
Part A: Serum Concentration of BIIB059 Day 169	3.7 nanogram per milliliter (ng/mL) Standard Deviation 1.5	12.8 nanogram per milliliter (ng/mL) Standard Deviation 4.8	32.0 nanogram per milliliter (ng/mL) Standard Deviation 18.6	—
Part A: Serum Concentration of BIIB059 Day 197	0.9 nanogram per milliliter (ng/mL) Standard Deviation 0.6	4.1 nanogram per milliliter (ng/mL) Standard Deviation 2.3	12.6 nanogram per milliliter (ng/mL) Standard Deviation 10.3	—
Part A: Serum Concentration of BIIB059 Day 253	—	0.4 nanogram per milliliter (ng/mL) Standard Deviation NA Since only 1 participant was evaluated, standard deviation was not estimable.	2.8 nanogram per milliliter (ng/mL) Standard Deviation 2.5	—

SECONDARY outcome

Timeframe: Part B: pre-dose on Days 1, 29, 85 and post-dose on Days 1, 29, 85, 113, 141, 169 and 197

Population: The PK population included the safety participants who had at least 1 PK concentration measurement. Number analyzed is the number of participants with data available for analysis at the specified time point.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=26 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=25 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=48 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part B: Serum Concentration of BIIB059 Day 8	6.8 ng/mL Standard Deviation 6.6	13.3 ng/mL Standard Deviation 6.1	47.8 ng/mL Standard Deviation 16.9	—
Part B: Serum Concentration of BIIB059 Day 29: Pre-dose	8.3 ng/mL Standard Deviation 7.1	16.9 ng/mL Standard Deviation 9.1	60.2 ng/mL Standard Deviation 23.3	—
Part B: Serum Concentration of BIIB059 Day 169	2.4 ng/mL Standard Deviation 2.0	2.2 ng/mL Standard Deviation 1.1	7.4 ng/mL Standard Deviation 5.0	—
Part B: Serum Concentration of BIIB059 Day 197	0.8 ng/mL Standard Deviation 0.7	1.1 ng/mL Standard Deviation 0.4	3.4 ng/mL Standard Deviation 2.3	—
Part B: Serum Concentration of BIIB059 Day 1: Pre-dose	0.0 ng/mL Standard Deviation 0.1	0.1 ng/mL Standard Deviation 0.2	0.0 ng/mL Standard Deviation 0.1	—
Part B: Serum Concentration of BIIB059 Day 1: Post-dose	0.4 ng/mL Standard Deviation 0.3	1.1 ng/mL Standard Deviation 1.1	2.9 ng/mL Standard Deviation 3.7	—
Part B: Serum Concentration of BIIB059 Day 29: Post-dose	8.7 ng/mL Standard Deviation 6.6	17.6 ng/mL Standard Deviation 10.2	61.0 ng/mL Standard Deviation 24.2	—
Part B: Serum Concentration of BIIB059 Day 85: Pre-dose	3.8 ng/mL Standard Deviation 3.4	11.0 ng/mL Standard Deviation 6.5	42.0 ng/mL Standard Deviation 17.1	—
Part B: Serum Concentration of BIIB059 Day 85: Post-dose	4.1 ng/mL Standard Deviation 3.6	11.6 ng/mL Standard Deviation 5.8	42.0 ng/mL Standard Deviation 17.0	—
Part B: Serum Concentration of BIIB059 Day 113	4.6 ng/mL Standard Deviation 5.9	12.1 ng/mL Standard Deviation 6.5	43.2 ng/mL Standard Deviation 14.3	—
Part B: Serum Concentration of BIIB059 Day 141	2.5 ng/mL Standard Deviation 3.3	4.6 ng/mL Standard Deviation 3.7	19.3 ng/mL Standard Deviation 9.6	—

Adverse Events

Part A: Placebo

Serious events: 6 serious events

Other events: 22 other events

Deaths: 3 deaths

Part A: BIIB059 50 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A: BIIB059 150 mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Part A: BIIB059 450 mg

Serious events: 3 serious events

Other events: 22 other events

Deaths: 0 deaths

Part B: Placebo

Serious events: 3 serious events

Other events: 19 other events

Deaths: 0 deaths

Part B: BIIB059 50 mg

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Part B: BIIB059 150 mg

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Part B: BIIB059 450 mg

Serious events: 3 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Placebo n=56 participants at risk Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 participants at risk Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=6 participants at risk Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=64 participants at risk Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part B: Placebo n=33 participants at risk Participants with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.	Part B: BIIB059 50 mg n=26 participants at risk Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.	Part B: BIIB059 150 mg n=25 participants at risk Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.	Part B: BIIB059 450 mg n=48 participants at risk Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Cardiac disorders Myocardial infarction	1.8% 1/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.0% 1/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Cardiac disorders Supraventricular tachycardia	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	2.1% 1/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Eye disorders Retinal artery thrombosis	1.8% 1/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Eye disorders Visual impairment	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.8% 1/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Gastrointestinal disorders Ileus	1.8% 1/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Gastrointestinal disorders Incarcerated umbilical hernia	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.0% 1/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Gastrointestinal disorders Intestinal perforation	1.8% 1/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Immune system disorders Hypersensitivity	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	2.1% 1/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Infections and infestations Gastroenteritis bacterial	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.0% 1/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Infections and infestations Parasitic gastroenteritis	1.8% 1/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Infections and infestations Pneumonia	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.0% 1/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Infections and infestations Systemic viral infection	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.0% 1/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Infections and infestations Urosepsis	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.0% 1/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	1.6% 1/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Injury, poisoning and procedural complications Cervical vertebral fracture	1.8% 1/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Injury, poisoning and procedural complications Road traffic accident	1.8% 1/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Metabolism and nutrition disorders Hypokalaemia	1.8% 1/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Musculoskeletal and connective tissue disorders Muscular weakness	1.8% 1/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.0% 1/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	8.0% 2/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin angiosarcoma	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	2.1% 1/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	2.1% 1/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Nervous system disorders Ataxia	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	1.6% 1/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Nervous system disorders Cerebrovascular disorder	1.8% 1/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Nervous system disorders Epilepsy	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	1.6% 1/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Nervous system disorders Headache	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	1.6% 1/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.8% 1/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Nervous system disorders Migraine	1.8% 1/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Nervous system disorders Paraesthesia	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.8% 1/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	1.6% 1/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Vascular disorders Hypertension	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.0% 1/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Blood and lymphatic system disorders Anaemia	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.0% 1/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.

Other adverse events

Other adverse events
Measure	Part A: Placebo n=56 participants at risk Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 participants at risk Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=6 participants at risk Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=64 participants at risk Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part B: Placebo n=33 participants at risk Participants with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.	Part B: BIIB059 50 mg n=26 participants at risk Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.	Part B: BIIB059 150 mg n=25 participants at risk Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.	Part B: BIIB059 450 mg n=48 participants at risk Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Gastrointestinal disorders Diarrhoea	5.4% 3/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.7% 3/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Gastrointestinal disorders Nausea	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	1.6% 1/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	9.1% 3/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.8% 1/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	2.1% 1/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
General disorders Asthenia	3.6% 2/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	1.6% 1/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
General disorders Fatigue	1.8% 1/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	1.6% 1/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	7.7% 2/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.2% 2/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
General disorders Injection site erythema	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.1% 2/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.0% 1/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	11.5% 3/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	8.0% 2/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	8.3% 4/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Infections and infestations Influenza	3.6% 2/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	33.3% 2/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	1.6% 1/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	7.7% 2/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.0% 1/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.2% 2/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Infections and infestations Nasopharyngitis	3.6% 2/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.7% 3/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	6.1% 2/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	7.7% 2/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	20.0% 5/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	6.2% 3/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Infections and infestations Sinusitis	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.0% 1/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	8.0% 2/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	2.1% 1/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Infections and infestations Upper respiratory tract infection	10.7% 6/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.1% 2/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.0% 1/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	7.7% 2/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	8.0% 2/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.2% 2/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Infections and infestations Urinary tract infection	7.1% 4/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	6.2% 4/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	7.7% 2/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	2.1% 1/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Musculoskeletal and connective tissue disorders Arthralgia	3.6% 2/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.1% 2/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	6.1% 2/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.8% 1/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	8.0% 2/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	6.2% 3/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	11.5% 3/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	2.1% 1/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	1.8% 1/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	9.1% 3/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	7.7% 2/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	8.0% 2/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.2% 2/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Nervous system disorders Headache	14.3% 8/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	1.6% 1/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	9.1% 3/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	23.1% 6/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.2% 2/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.0% 1/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	7.7% 2/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.0% 1/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.2% 2/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Skin and subcutaneous tissue disorders Pruritus	3.6% 2/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.1% 2/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.0% 1/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.8% 1/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	12.0% 3/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	2.1% 1/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Blood and lymphatic system disorders Anaemia	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Blood and lymphatic system disorders Neutrophilia	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Gastrointestinal disorders Spigelian hernia	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
General disorders Injection site warmth	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Infections and infestations Cystitis	3.6% 2/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Infections and infestations Rhinitis	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Injury, poisoning and procedural complications Fall	1.8% 1/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	6.2% 4/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Injury, poisoning and procedural complications Repetitive strain injury	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Investigations Neutrophil count increased	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Nervous system disorders Tension headache	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	1.6% 1/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Skin and subcutaneous tissue disorders Purpura	1.8% 1/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	16.7% 1/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	6.1% 2/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
General disorders Injection site pruritus	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.8% 1/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	6.2% 3/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
General disorders Injection site rash	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	6.2% 3/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
General disorders Pyrexia	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	6.1% 2/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.0% 1/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.2% 2/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Infections and infestations Bronchitis	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	6.1% 2/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.8% 1/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.2% 2/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Investigations Transaminases increased	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	6.1% 2/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.8% 1/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	6.1% 2/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.8% 1/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.0% 1/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.2% 2/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Skin and subcutaneous tissue disorders Cutaneous lupus erythematosus	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	12.1% 4/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.8% 1/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.0% 1/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.2% 2/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Vascular disorders Hypertension	0.00% 0/56 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/6 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/64 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	3.0% 1/33 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	0.00% 0/26 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	4.0% 1/25 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.	6.2% 3/48 • Part A: up to Week 36, Part B: up to Week 28 Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.

Additional Information

US Biogen Clinical Trial Center

Biogen

Phone: 866-633-4636

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	Part A: Placebo n=54 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 50 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 150 mg n=6 Participants Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.	Part A: BIIB059 450 mg n=63 Participants Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 9V IgG AB: Change at Week 24	0.3963 milligrams per liter (mg/L) Standard Deviation 1.70256	-0.0767 milligrams per liter (mg/L) Standard Deviation 0.64252	-0.5750 milligrams per liter (mg/L) Standard Deviation 1.02039	0.6701 milligrams per liter (mg/L) Standard Deviation 4.70300
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 10A IgG AB: Baseline	6.443 milligrams per liter (mg/L) Standard Deviation 5.8006	17.847 milligrams per liter (mg/L) Standard Deviation 32.7160	14.040 milligrams per liter (mg/L) Standard Deviation 14.0133	7.631 milligrams per liter (mg/L) Standard Deviation 8.2417
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 15B IgG AB: Baseline	3.926 milligrams per liter (mg/L) Standard Deviation 5.7931	6.287 milligrams per liter (mg/L) Standard Deviation 7.4576	4.332 milligrams per liter (mg/L) Standard Deviation 4.0216	3.690 milligrams per liter (mg/L) Standard Deviation 5.3754
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 18C IgG AB: Baseline	3.229 milligrams per liter (mg/L) Standard Deviation 4.8212	3.475 milligrams per liter (mg/L) Standard Deviation 2.2460	2.980 milligrams per liter (mg/L) Standard Deviation 1.8997	2.485 milligrams per liter (mg/L) Standard Deviation 3.8363
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 18C IgG AB: Change at Week 24	-0.096 milligrams per liter (mg/L) Standard Deviation 2.8194	-1.172 milligrams per liter (mg/L) Standard Deviation 2.2061	-0.915 milligrams per liter (mg/L) Standard Deviation 1.0038	0.054 milligrams per liter (mg/L) Standard Deviation 2.2468
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 1 IgG AB: Baseline	2.017 milligrams per liter (mg/L) Standard Deviation 4.9787	3.873 milligrams per liter (mg/L) Standard Deviation 3.8400	2.705 milligrams per liter (mg/L) Standard Deviation 5.3558	1.495 milligrams per liter (mg/L) Standard Deviation 3.3589
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 1 IgG AB: Change at Week 24	0.445 milligrams per liter (mg/L) Standard Deviation 1.9595	0.055 milligrams per liter (mg/L) Standard Deviation 2.9840	-0.565 milligrams per liter (mg/L) Standard Deviation 1.4395	0.475 milligrams per liter (mg/L) Standard Deviation 3.5101
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 2 IgG AB: Baseline	1.562 milligrams per liter (mg/L) Standard Deviation 2.4661	5.715 milligrams per liter (mg/L) Standard Deviation 6.9239	4.202 milligrams per liter (mg/L) Standard Deviation 4.8105	1.626 milligrams per liter (mg/L) Standard Deviation 2.6861
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 2 IgG AB: Change at Week 24	0.014 milligrams per liter (mg/L) Standard Deviation 0.8316	-1.648 milligrams per liter (mg/L) Standard Deviation 7.1790	-1.975 milligrams per liter (mg/L) Standard Deviation 3.2500	-0.011 milligrams per liter (mg/L) Standard Deviation 1.2676
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 3 IgG AB: Baseline	1.2607 milligrams per liter (mg/L) Standard Deviation 1.77918	2.1450 milligrams per liter (mg/L) Standard Deviation 2.39861	1.2733 milligrams per liter (mg/L) Standard Deviation 0.96790	1.6579 milligrams per liter (mg/L) Standard Deviation 3.35454
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 3 IgG AB: Change at Week 24	-0.0886 milligrams per liter (mg/L) Standard Deviation 0.75890	-0.2017 milligrams per liter (mg/L) Standard Deviation 2.43817	-0.2067 milligrams per liter (mg/L) Standard Deviation 1.39370	0.8122 milligrams per liter (mg/L) Standard Deviation 3.62090
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 4 IgG AB: Baseline	0.734 milligrams per liter (mg/L) Standard Deviation 1.2954	2.602 milligrams per liter (mg/L) Standard Deviation 4.4908	1.317 milligrams per liter (mg/L) Standard Deviation 1.5754	0.429 milligrams per liter (mg/L) Standard Deviation 0.5696
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 4 IgG AB: Change at Week 24	-0.025 milligrams per liter (mg/L) Standard Deviation 0.5104	-1.510 milligrams per liter (mg/L) Standard Deviation 4.9524	-0.795 milligrams per liter (mg/L) Standard Deviation 1.6009	0.060 milligrams per liter (mg/L) Standard Deviation 0.6525
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 5 IgG AB: Baseline	4.921 milligrams per liter (mg/L) Standard Deviation 4.2218	10.693 milligrams per liter (mg/L) Standard Deviation 17.4616	13.507 milligrams per liter (mg/L) Standard Deviation 17.7231	4.442 milligrams per liter (mg/L) Standard Deviation 3.9255
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 5 IgG AB: Change at Week 24	0.813 milligrams per liter (mg/L) Standard Deviation 3.9116	-4.692 milligrams per liter (mg/L) Standard Deviation 19.3477	-7.322 milligrams per liter (mg/L) Standard Deviation 16.4934	0.329 milligrams per liter (mg/L) Standard Deviation 2.3390
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 6 IgG AB: Baseline	3.348 milligrams per liter (mg/L) Standard Deviation 6.4940	4.462 milligrams per liter (mg/L) Standard Deviation 4.1178	4.458 milligrams per liter (mg/L) Standard Deviation 6.1968	1.957 milligrams per liter (mg/L) Standard Deviation 2.7845
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 6 IgG AB: Change at Week 24	-0.448 milligrams per liter (mg/L) Standard Deviation 2.4975	-2.168 milligrams per liter (mg/L) Standard Deviation 5.1775	-3.083 milligrams per liter (mg/L) Standard Deviation 5.3923	0.070 milligrams per liter (mg/L) Standard Deviation 2.4772
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 7 IgG AB: Baseline	6.4300 milligrams per liter (mg/L) Standard Deviation 10.99806	8.5333 milligrams per liter (mg/L) Standard Deviation 7.97928	7.0033 milligrams per liter (mg/L) Standard Deviation 8.53321	3.0983 milligrams per liter (mg/L) Standard Deviation 6.90958
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 7 IgG AB: Change at Week 24	-1.0336 milligrams per liter (mg/L) Standard Deviation 5.35192	-1.3283 milligrams per liter (mg/L) Standard Deviation 7.23188	-2.8917 milligrams per liter (mg/L) Standard Deviation 5.30027	0.3053 milligrams per liter (mg/L) Standard Deviation 3.13517
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 8 IgG AB: Baseline	3.1978 milligrams per liter (mg/L) Standard Deviation 7.08938	3.1933 milligrams per liter (mg/L) Standard Deviation 3.01698	2.6183 milligrams per liter (mg/L) Standard Deviation 3.21210	1.5890 milligrams per liter (mg/L) Standard Deviation 4.46616
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 8 IgG AB: Change at Week 24	0.0925 milligrams per liter (mg/L) Standard Deviation 1.10700	-1.3300 milligrams per liter (mg/L) Standard Deviation 3.85666	-1.5483 milligrams per liter (mg/L) Standard Deviation 3.27227	0.1281 milligrams per liter (mg/L) Standard Deviation 0.84548
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 9N IgG AB: Baseline	1.781 milligrams per liter (mg/L) Standard Deviation 2.9291	2.710 milligrams per liter (mg/L) Standard Deviation 3.7028	2.810 milligrams per liter (mg/L) Standard Deviation 4.4518	2.337 milligrams per liter (mg/L) Standard Deviation 4.6658
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 9N IgG AB: Change at Week 24	0.217 milligrams per liter (mg/L) Standard Deviation 1.7957	-1.327 milligrams per liter (mg/L) Standard Deviation 3.8703	-0.907 milligrams per liter (mg/L) Standard Deviation 2.8144	0.499 milligrams per liter (mg/L) Standard Deviation 4.0782
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 9V IgG AB: Baseline	1.0274 milligrams per liter (mg/L) Standard Deviation 1.44706	1.8300 milligrams per liter (mg/L) Standard Deviation 3.00647	1.5900 milligrams per liter (mg/L) Standard Deviation 1.79117	2.2696 milligrams per liter (mg/L) Standard Deviation 4.71508
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 10A IgG AB: Change at Week 24	0.502 milligrams per liter (mg/L) Standard Deviation 7.1412	-8.062 milligrams per liter (mg/L) Standard Deviation 36.3708	0.100 milligrams per liter (mg/L) Standard Deviation 9.5476	-0.384 milligrams per liter (mg/L) Standard Deviation 5.8464
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 11A IgG AB: Baseline	1.768 milligrams per liter (mg/L) Standard Deviation 1.9872	3.203 milligrams per liter (mg/L) Standard Deviation 3.6280	4.095 milligrams per liter (mg/L) Standard Deviation 4.7768	2.308 milligrams per liter (mg/L) Standard Deviation 3.0647
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 11A IgG AB: Change at Week 24	0.241 milligrams per liter (mg/L) Standard Deviation 1.1929	-1.615 milligrams per liter (mg/L) Standard Deviation 4.5191	-0.782 milligrams per liter (mg/L) Standard Deviation 5.3918	-0.276 milligrams per liter (mg/L) Standard Deviation 1.6589
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 12F IgG AB: Baseline	0.852 milligrams per liter (mg/L) Standard Deviation 2.5002	2.355 milligrams per liter (mg/L) Standard Deviation 3.5388	2.077 milligrams per liter (mg/L) Standard Deviation 2.0373	0.262 milligrams per liter (mg/L) Standard Deviation 0.3381
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 12F IgG AB: Change at Week 24	0.060 milligrams per liter (mg/L) Standard Deviation 0.8496	-1.648 milligrams per liter (mg/L) Standard Deviation 3.7849	-1.220 milligrams per liter (mg/L) Standard Deviation 1.7397	-0.072 milligrams per liter (mg/L) Standard Deviation 0.1772
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 14 IgG AB: Baseline	7.910 milligrams per liter (mg/L) Standard Deviation 11.3177	13.982 milligrams per liter (mg/L) Standard Deviation 16.1988	8.167 milligrams per liter (mg/L) Standard Deviation 9.5488	5.183 milligrams per liter (mg/L) Standard Deviation 6.5611
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 14 IgG AB: Change at Week 24	-0.635 milligrams per liter (mg/L) Standard Deviation 6.6892	-7.027 milligrams per liter (mg/L) Standard Deviation 19.5245	-0.798 milligrams per liter (mg/L) Standard Deviation 7.1605	0.597 milligrams per liter (mg/L) Standard Deviation 3.6401
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 15B IgG AB: Change at Week 24	0.603 milligrams per liter (mg/L) Standard Deviation 5.1284	-2.262 milligrams per liter (mg/L) Standard Deviation 9.1738	-1.607 milligrams per liter (mg/L) Standard Deviation 4.1148	-0.341 milligrams per liter (mg/L) Standard Deviation 2.2893
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 17F IgG AB: Baseline	4.817 milligrams per liter (mg/L) Standard Deviation 5.7702	11.422 milligrams per liter (mg/L) Standard Deviation 16.0156	11.952 milligrams per liter (mg/L) Standard Deviation 10.2915	4.277 milligrams per liter (mg/L) Standard Deviation 4.8458
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 17F IgG AB: Change at Week 24	0.427 milligrams per liter (mg/L) Standard Deviation 4.6695	-6.123 milligrams per liter (mg/L) Standard Deviation 17.3744	-5.898 milligrams per liter (mg/L) Standard Deviation 9.5001	1.330 milligrams per liter (mg/L) Standard Deviation 4.8122
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 19A IgG AB: Baseline	15.2372 milligrams per liter (mg/L) Standard Deviation 11.46102	35.2000 milligrams per liter (mg/L) Standard Deviation 58.79083	50.3175 milligrams per liter (mg/L) Standard Deviation 56.06189	14.9554 milligrams per liter (mg/L) Standard Deviation 11.40262
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 19A IgG AB: Change at Week 24	2.2418 milligrams per liter (mg/L) Standard Deviation 6.97357	-18.0750 milligrams per liter (mg/L) Standard Deviation 61.75995	-29.3558 milligrams per liter (mg/L) Standard Deviation 44.83082	4.0988 milligrams per liter (mg/L) Standard Deviation 9.00464
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 19F IgG AB: Baseline	4.203 milligrams per liter (mg/L) Standard Deviation 6.4231	10.857 milligrams per liter (mg/L) Standard Deviation 14.6665	8.353 milligrams per liter (mg/L) Standard Deviation 8.4621	2.609 milligrams per liter (mg/L) Standard Deviation 3.1856
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 19F IgG AB: Change at Week 24	0.651 milligrams per liter (mg/L) Standard Deviation 3.5642	-6.447 milligrams per liter (mg/L) Standard Deviation 16.0973	-3.673 milligrams per liter (mg/L) Standard Deviation 8.5727	1.136 milligrams per liter (mg/L) Standard Deviation 3.2837
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 20 IgG AB: Baseline	5.4506 milligrams per liter (mg/L) Standard Deviation 6.82628	26.7958 milligrams per liter (mg/L) Standard Deviation 45.54328	21.8742 milligrams per liter (mg/L) Standard Deviation 22.32961	4.0902 milligrams per liter (mg/L) Standard Deviation 4.01659
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 20 IgG AB: Change at Week 24	0.0455 milligrams per liter (mg/L) Standard Deviation 4.96426	-21.4475 milligrams per liter (mg/L) Standard Deviation 46.04992	-13.0942 milligrams per liter (mg/L) Standard Deviation 16.16771	1.2437 milligrams per liter (mg/L) Standard Deviation 2.42526
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 22F IgG AB: Baseline	1.563 milligrams per liter (mg/L) Standard Deviation 2.0162	5.743 milligrams per liter (mg/L) Standard Deviation 10.5586	5.525 milligrams per liter (mg/L) Standard Deviation 6.4123	1.138 milligrams per liter (mg/L) Standard Deviation 1.6187
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 22F IgG AB: Change at Week 24	0.244 milligrams per liter (mg/L) Standard Deviation 1.8324	-4.000 milligrams per liter (mg/L) Standard Deviation 11.1710	-3.657 milligrams per liter (mg/L) Standard Deviation 6.6997	0.087 milligrams per liter (mg/L) Standard Deviation 0.9350
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 23F IgG AB: Baseline	1.401 milligrams per liter (mg/L) Standard Deviation 2.0138	1.897 milligrams per liter (mg/L) Standard Deviation 1.3080	0.685 milligrams per liter (mg/L) Standard Deviation 0.3293	1.797 milligrams per liter (mg/L) Standard Deviation 2.7461
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 23F IgG AB: Change at Week 24	0.078 milligrams per liter (mg/L) Standard Deviation 1.0468	-0.150 milligrams per liter (mg/L) Standard Deviation 1.3425	0.190 milligrams per liter (mg/L) Standard Deviation 0.4725	0.125 milligrams per liter (mg/L) Standard Deviation 1.8192
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 33F IgG AB: Baseline	2.610 milligrams per liter (mg/L) Standard Deviation 4.4802	6.600 milligrams per liter (mg/L) Standard Deviation 12.2931	5.630 milligrams per liter (mg/L) Standard Deviation 5.3371	1.800 milligrams per liter (mg/L) Standard Deviation 2.2552
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 Sero 33F IgG AB: Change at Week 24	-0.392 milligrams per liter (mg/L) Standard Deviation 1.7998	-5.042 milligrams per liter (mg/L) Standard Deviation 12.7997	-3.740 milligrams per liter (mg/L) Standard Deviation 4.4122	0.066 milligrams per liter (mg/L) Standard Deviation 1.1380