Trial Outcomes & Findings for A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes (NCT NCT02846545)

NCT ID: NCT02846545

Last Updated: 2025-02-04

Results Overview

MMTT-Stimulated 4-Hour C-peptide AUC was defined as the mean area under the C-peptide level time curve over the 4-hour period divided by the duration after a mixed-meal tolerance test.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 84 participants
• Primary outcome timeframe: Week 52
• Results posted on: 2025-02-04

Participant Flow

Participant milestones

Measure	Placebo Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up \[FU\] period).	Golimumab Participants in active treatment period weighing less than (\<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m\^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (\>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing \<45 kg received a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing \>=45 kg received maintenance dose of golimumab 50 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.
Active Treatment Period: Week 0-52 STARTED	28	56
Active Treatment Period: Week 0-52 COMPLETED	25	50
Active Treatment Period: Week 0-52 NOT COMPLETED	3	6
Off-therapy FU:Wk 52-104 & OLE: Wk 0-60 STARTED	25	49
Off-therapy FU:Wk 52-104 & OLE: Wk 0-60 Participants Who Entered OLE Period	0	5
Off-therapy FU:Wk 52-104 & OLE: Wk 0-60 Participants Who Completed OLE Period	0	1
Off-therapy FU:Wk 52-104 & OLE: Wk 0-60 COMPLETED	23	47
Off-therapy FU:Wk 52-104 & OLE: Wk 0-60 NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Placebo Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up \[FU\] period).	Golimumab Participants in active treatment period weighing less than (\<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m\^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (\>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing \<45 kg received a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing \>=45 kg received maintenance dose of golimumab 50 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.
Active Treatment Period: Week 0-52 Lost to Follow-up	1	1
Active Treatment Period: Week 0-52 Non-compliance with study drug	1	0
Active Treatment Period: Week 0-52 Withdrawal by Subject	1	5
Off-therapy FU:Wk 52-104 & OLE: Wk 0-60 Lost to Follow-up	1	1
Off-therapy FU:Wk 52-104 & OLE: Wk 0-60 Other	1	1

Baseline Characteristics

A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes

Baseline characteristics by cohort

Measure	Placebo n=28 Participants Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up \[FU\] period).	Golimumab n=56 Participants Participants in active treatment period weighing less than (\<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m\^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (\>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing \<45 kg received a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing \>=45 kg received maintenance dose of golimumab 50 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.	Total n=84 Participants Total of all reporting groups
Age, Continuous	13.5 years STANDARD_DEVIATION 4.01 • n=5 Participants	13.3 years STANDARD_DEVIATION 3.73 • n=7 Participants	13.4 years STANDARD_DEVIATION 3.8 • n=5 Participants
Age, Customized Children (2-11 years)	8 Participants n=5 Participants	20 Participants n=7 Participants	28 Participants n=5 Participants
Age, Customized Adolescents (12-17 years)	13 Participants n=5 Participants	27 Participants n=7 Participants	40 Participants n=5 Participants
Age, Customized Adults (18-64 years)	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Age, Customized From 65 to 84 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 85 years and over	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	25 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	31 Participants n=7 Participants	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	51 Participants n=7 Participants	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	46 Participants n=7 Participants	72 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 52

Population: Full Analysis Set (FAS) included all randomized participants who took at least one dose (complete or partial) of study agent. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure.

MMTT-Stimulated 4-Hour C-peptide AUC was defined as the mean area under the C-peptide level time curve over the 4-hour period divided by the duration after a mixed-meal tolerance test.

Outcome measures

Measure	Placebo n=25 Participants Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up \[FU\] period).	Golimumab n=50 Participants Participants in active treatment period weighing less than (\<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m\^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (\>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing \<45 kg received a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing \>=45 kg received maintenance dose of golimumab 50 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.
Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) at Week 52	0.43 picomoles per milliliter (pmol/mL) Standard Deviation 0.388 • Interval 0.388 to	0.64 picomoles per milliliter (pmol/mL) Standard Deviation 0.423 • Interval 0.423 to

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: FAS included all randomized participants who took at least one dose (complete or partial) of study agent. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Change from baseline in daily insulin use at Week 52 was reported.

Outcome measures

Measure	Placebo n=17 Participants Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up \[FU\] period).	Golimumab n=42 Participants Participants in active treatment period weighing less than (\<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m\^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (\>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing \<45 kg received a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing \>=45 kg received maintenance dose of golimumab 50 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.
Active Treatment Period: Change From Baseline in Insulin Use in Units Per Kilogram Body Weight Per Day	0.239 units/kilogram/day Standard Deviation 0.2225	0.057 units/kilogram/day Standard Deviation 0.2850

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: FAS included all randomized participants who took at least one dose (complete or partial) of study agent. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Change from baseline in glycosylated HbA1c at Week 52 was reported.

Outcome measures

Measure	Placebo n=28 Participants Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up \[FU\] period).	Golimumab n=50 Participants Participants in active treatment period weighing less than (\<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m\^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (\>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing \<45 kg received a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing \>=45 kg received maintenance dose of golimumab 50 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.
Active Treatment Period: Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 52	0.61 HbA1C percent (%) Standard Deviation 1.368	0.35 HbA1C percent (%) Standard Deviation 1.851

SECONDARY outcome

Timeframe: Up to Week 52

Population: FAS which had all randomized participants who took at least one dose (complete or partial) of study agent.

A hypoglycemic event was defined as either a biochemically confirmed hypoglycemic episode or a severe hypoglycemic event. The hypoglycemia event rate (number of hypoglycemia episodes per patient-year) was defined as blood glucose levels of less than and equal to (<=) 70, 55, and 35 mg/dL or clinical sequelae consistent with severe hypoglycemia in the absence of a BG reading.

Outcome measures

Measure	Placebo n=28 Participants Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up \[FU\] period).	Golimumab n=56 Participants Participants in active treatment period weighing less than (\<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m\^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (\>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing \<45 kg received a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing \>=45 kg received maintenance dose of golimumab 50 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.
Hypoglycemic Event Rates	43.36 events per patient-year	39.01 events per patient-year

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 26, 38, 52, 78 and 104

Population: FAS included all randomized participants who took at least one dose (complete or partial) of study agent. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints.

MMTT-Stimulated 4-Hour C-peptide AUC is the mean area under the C-peptide level-time curve over the 4-hour period divided by the duration after a mixed-meal tolerance test.

Outcome measures

Measure	Placebo n=28 Participants Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up \[FU\] period).	Golimumab n=56 Participants Participants in active treatment period weighing less than (\<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m\^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (\>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing \<45 kg received a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing \>=45 kg received maintenance dose of golimumab 50 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.
Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time Week 104	0.25 pmol/mL Standard Deviation 0.273	0.35 pmol/mL Standard Deviation 0.360
Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time Baseline	0.88 pmol/mL Standard Deviation 0.634	0.78 pmol/mL Standard Deviation 0.396
Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time Week 12	0.62 pmol/mL Standard Deviation 0.426	0.78 pmol/mL Standard Deviation 0.355
Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time Week 26	0.55 pmol/mL Standard Deviation 0.424	0.76 pmol/mL Standard Deviation 0.380
Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time Week 38	0.53 pmol/mL Standard Deviation 0.423	0.73 pmol/mL Standard Deviation 0.424
Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time Week 52	0.43 pmol/mL Standard Deviation 0.388	0.64 pmol/mL Standard Deviation 0.423
Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time Week 78	0.31 pmol/mL Standard Deviation 0.264	0.45 pmol/mL Standard Deviation 0.385

SECONDARY outcome

Timeframe: Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)

Population: The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population.

An adverse event (AE) was defined as any untoward medical occurrence in clinical study subject administered medicinal product. It could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Treatment emergent AEs were defined as AEs with onset during the treatment phase or that are a consequence of a pre-existing condition that has worsened since baseline.

Outcome measures

Measure	Placebo n=28 Participants Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up \[FU\] period).	Golimumab n=56 Participants Participants in active treatment period weighing less than (\<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m\^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (\>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing \<45 kg received a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing \>=45 kg received maintenance dose of golimumab 50 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability Up to Week 52	82.1 percentage of participants	91.1 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability Up to Week 104	89.3 percentage of participants	96.4 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)

Population: The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population.

An AE was defined as any untoward medical occurrence in clinical study participant administered medicinal product. It could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. A serious AE was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious treatment via medicinal product and was medically important.

Outcome measures

Measure	Placebo n=28 Participants Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up \[FU\] period).	Golimumab n=56 Participants Participants in active treatment period weighing less than (\<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m\^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (\>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing \<45 kg received a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing \>=45 kg received maintenance dose of golimumab 50 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.
Percentage of Participants With Serious Adverse Events Up to Week 52	3.6 percentage participants	1.8 percentage participants
Percentage of Participants With Serious Adverse Events Up to Week 104	7.1 percentage participants	8.9 percentage participants

SECONDARY outcome

Timeframe: Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)

Population: The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population.

Participants having 1 or more severe infections were evaluated and reported.

Outcome measures

Measure	Placebo n=28 Participants Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up \[FU\] period).	Golimumab n=56 Participants Participants in active treatment period weighing less than (\<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m\^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (\>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing \<45 kg received a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing \>=45 kg received maintenance dose of golimumab 50 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.
Percentage of Participants With Severe Infections Through Week 52 and Week 104 Up to Week 52	60.7 percentage of participants	71.4 percentage of participants
Percentage of Participants With Severe Infections Through Week 52 and Week 104 Up to Week 104	67.9 percentage of participants	75.0 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population.

Percentage of participants with study agent injection site reactions up to Week 52 were reported.

Outcome measures

Measure	Placebo n=28 Participants Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up \[FU\] period).	Golimumab n=56 Participants Participants in active treatment period weighing less than (\<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m\^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (\>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing \<45 kg received a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing \>=45 kg received maintenance dose of golimumab 50 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.
Active Treatment Period: Percentage of Participants With Study Agent Injection Site Reactions Up to Week 52	28.6 percentage of participants	23.2 percentage of participants

SECONDARY outcome

Timeframe: Preinjection: Week 0, Week 2, Week 4, Week 8, Week 12, and Week 26, Week 33, Week 38 (preinjection),Week 45 and Week 52 (preinjection), for active treatment period; Weeks 78 and 104 for Off-therapy follow-up period

Population: PK Analysis Set included all participants who received at least 1 golimumab injection and had sufficient PK samples for analysis. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints.

Serum samples were collected for the measurement of golimumab concentrations.

Outcome measures

Measure	Placebo n=56 Participants Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up \[FU\] period).	Golimumab Participants in active treatment period weighing less than (\<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m\^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (\>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing \<45 kg received a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing \>=45 kg received maintenance dose of golimumab 50 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.
Serum Golimumab Concentrations Week 0	0.00 micrograms per milliliter (mcg/mL) Standard Deviation 0.000	—
Serum Golimumab Concentrations Week 2	4.64 micrograms per milliliter (mcg/mL) Standard Deviation 1.506	—
Serum Golimumab Concentrations Week 4	6.85 micrograms per milliliter (mcg/mL) Standard Deviation 2.168	—
Serum Golimumab Concentrations Week 8	4.67 micrograms per milliliter (mcg/mL) Standard Deviation 1.930	—
Serum Golimumab Concentrations Week 12	3.74 micrograms per milliliter (mcg/mL) Standard Deviation 2.032	—
Serum Golimumab Concentrations Week 26	3.37 micrograms per milliliter (mcg/mL) Standard Deviation 2.011	—
Serum Golimumab Concentrations Week 33	4.41 micrograms per milliliter (mcg/mL) Standard Deviation 2.825	—
Serum Golimumab Concentrations Week 38	3.06 micrograms per milliliter (mcg/mL) Standard Deviation 2.127	—
Serum Golimumab Concentrations Week 45	4.44 micrograms per milliliter (mcg/mL) Standard Deviation 2.828	—
Serum Golimumab Concentrations Week 52	2.89 micrograms per milliliter (mcg/mL) Standard Deviation 2.022	—
Serum Golimumab Concentrations Week 78	0.00 micrograms per milliliter (mcg/mL) Standard Deviation 0.007	—
Serum Golimumab Concentrations Week 104	0.00 micrograms per milliliter (mcg/mL) Standard Deviation 0.000	—

SECONDARY outcome

Timeframe: Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)

Population: PK Analysis Set included all participants with appropriate samples (had 1 or more samples) obtained after their first study agent administration.

Number of participants with antibodies to golimumab were reported.

Outcome measures

Measure	Placebo n=56 Participants Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up \[FU\] period).	Golimumab Participants in active treatment period weighing less than (\<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m\^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (\>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing \<45 kg received a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing \>=45 kg received maintenance dose of golimumab 50 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.
Number of Participants With Antibodies to Golimumab Up to Week 52	30 Participants	—
Number of Participants With Antibodies to Golimumab Up to Week 104	37 Participants	—

SECONDARY outcome

Timeframe: Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)

Population: PK Analysis Set included all the participants who were antibody positive, the peak titers for them were evaluated. Data was not collected and analyzed for this outcome measure due to change in planned analysis.

Titers of antibodies to golimumab were evaluated.

Outcome measures

Outcome data not reported

Adverse Events

Active Treatment Period: Placebo (Week 0 - 52)

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Active Treatment Period: Golimumab (Week 0 - 52)

Serious events: 1 serious events

Other events: 45 other events

Deaths: 0 deaths

Off-therapy Follow Up Period: Placebo (Week 52 - 104)

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Off-therapy Period: Golimumab (Week 52 - 104)

Serious events: 4 serious events

Other events: 26 other events

Deaths: 0 deaths

OLE Period: Golimumab (OLE Week 0-60 After Active Treatment Period)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Active Treatment Period: Placebo (Week 0 - 52) n=28 participants at risk Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week 0 through Week 52 to match the active arm.	Active Treatment Period: Golimumab (Week 0 - 52) n=56 participants at risk Participants in the active treatment period weighing less than (\<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m\^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (\>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52.	Off-therapy Follow Up Period: Placebo (Week 52 - 104) n=25 participants at risk Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up period).	Off-therapy Period: Golimumab (Week 52 - 104) n=49 participants at risk Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up period) and did not receive the study drug during this period (off-therapy follow-up period).	OLE Period: Golimumab (OLE Week 0-60 After Active Treatment Period) n=5 participants at risk Following the active treatment period, participants were assessed for response at Week 52 and and those who were responders and still in the off-therapy follow-up period were offered the option to enter the open-label extension (OLE) period. Participants weighing \<45 kg received a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing \>=45 kg received maintenance dose of golimumab 50 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in the off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.
Eye disorders Diplopia	0.00% 0/28 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	1.8% 1/56 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Hepatobiliary disorders Cholelithiasis	3.6% 1/28 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/56 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Metabolism and nutrition disorders Diabetic Ketoacidosis	0.00% 0/28 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/56 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	4.0% 1/25 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	8.2% 4/49 • Number of events 4 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Nervous system disorders Seizure	0.00% 0/28 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/56 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	20.0% 1/5 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.

Other adverse events

Measure	Active Treatment Period: Placebo (Week 0 - 52) n=28 participants at risk Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week 0 through Week 52 to match the active arm.	Active Treatment Period: Golimumab (Week 0 - 52) n=56 participants at risk Participants in the active treatment period weighing less than (\<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m\^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (\>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52.	Off-therapy Follow Up Period: Placebo (Week 52 - 104) n=25 participants at risk Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up period).	Off-therapy Period: Golimumab (Week 52 - 104) n=49 participants at risk Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up period) and did not receive the study drug during this period (off-therapy follow-up period).	OLE Period: Golimumab (OLE Week 0-60 After Active Treatment Period) n=5 participants at risk Following the active treatment period, participants were assessed for response at Week 52 and and those who were responders and still in the off-therapy follow-up period were offered the option to enter the open-label extension (OLE) period. Participants weighing \<45 kg received a maintenance dose of golimumab 30 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing \>=45 kg received maintenance dose of golimumab 50 mg/m\^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in the off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.
Blood and lymphatic system disorders Lymphadenopathy	7.1% 2/28 • Number of events 2 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	3.6% 2/56 • Number of events 2 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	2.0% 1/49 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Blood and lymphatic system disorders Neutropenia	0.00% 0/28 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	5.4% 3/56 • Number of events 4 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Gastrointestinal disorders Abdominal Pain	0.00% 0/28 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	5.4% 3/56 • Number of events 3 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Gastrointestinal disorders Abdominal Pain Upper	10.7% 3/28 • Number of events 3 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	5.4% 3/56 • Number of events 3 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Gastrointestinal disorders Diarrhoea	3.6% 1/28 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	8.9% 5/56 • Number of events 5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	2.0% 1/49 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Gastrointestinal disorders Nausea	7.1% 2/28 • Number of events 2 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	8.9% 5/56 • Number of events 7 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	4.0% 1/25 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	6.1% 3/49 • Number of events 3 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Gastrointestinal disorders Vomiting	7.1% 2/28 • Number of events 2 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	8.9% 5/56 • Number of events 5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	8.2% 4/49 • Number of events 5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
General disorders Fatigue	3.6% 1/28 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	5.4% 3/56 • Number of events 3 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
General disorders Injection Site Erythema	10.7% 3/28 • Number of events 4 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	16.1% 9/56 • Number of events 36 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
General disorders Injection Site Pain	7.1% 2/28 • Number of events 2 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	10.7% 6/56 • Number of events 11 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
General disorders Injection Site Swelling	0.00% 0/28 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	7.1% 4/56 • Number of events 14 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
General disorders Injection Site Urticaria	10.7% 3/28 • Number of events 13 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	3.6% 2/56 • Number of events 4 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
General disorders Pyrexia	3.6% 1/28 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	7.1% 4/56 • Number of events 5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	4.1% 2/49 • Number of events 2 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Immune system disorders Seasonal Allergy	0.00% 0/28 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	10.7% 6/56 • Number of events 6 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	4.0% 1/25 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	2.0% 1/49 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Infections and infestations Bronchitis	0.00% 0/28 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	5.4% 3/56 • Number of events 3 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	4.0% 1/25 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	2.0% 1/49 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Infections and infestations Ear Infection	3.6% 1/28 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/56 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	8.0% 2/25 • Number of events 2 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Infections and infestations Gastroenteritis	7.1% 2/28 • Number of events 2 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	8.9% 5/56 • Number of events 6 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	2.0% 1/49 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Infections and infestations Influenza	7.1% 2/28 • Number of events 2 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	10.7% 6/56 • Number of events 6 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	8.0% 2/25 • Number of events 2 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	2.0% 1/49 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Infections and infestations Nasopharyngitis	17.9% 5/28 • Number of events 8 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	17.9% 10/56 • Number of events 16 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	12.0% 3/25 • Number of events 4 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	8.2% 4/49 • Number of events 5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	20.0% 1/5 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Infections and infestations Otitis Media	7.1% 2/28 • Number of events 3 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/56 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Infections and infestations Pharyngitis Streptococcal	7.1% 2/28 • Number of events 2 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	5.4% 3/56 • Number of events 4 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	2.0% 1/49 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Infections and infestations Sinusitis	7.1% 2/28 • Number of events 2 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	7.1% 4/56 • Number of events 5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Infections and infestations Upper Respiratory Tract Infection	32.1% 9/28 • Number of events 11 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	30.4% 17/56 • Number of events 31 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	16.0% 4/25 • Number of events 4 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	16.3% 8/49 • Number of events 9 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Injury, poisoning and procedural complications Contusion	7.1% 2/28 • Number of events 4 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/56 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Injury, poisoning and procedural complications Limb Injury	0.00% 0/28 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	5.4% 3/56 • Number of events 3 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Investigations Glycosylated Haemoglobin Increased	0.00% 0/28 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/56 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	6.1% 3/49 • Number of events 3 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Metabolism and nutrition disorders Hypoglycaemia	7.1% 2/28 • Number of events 63 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	25.0% 14/56 • Number of events 104 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	8.0% 2/25 • Number of events 90 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	18.4% 9/49 • Number of events 141 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	40.0% 2/5 • Number of events 9 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/28 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	5.4% 3/56 • Number of events 4 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Nervous system disorders Headache	10.7% 3/28 • Number of events 4 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	19.6% 11/56 • Number of events 27 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	4.0% 1/25 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	4.1% 2/49 • Number of events 3 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Psychiatric disorders Insomnia	0.00% 0/28 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	5.4% 3/56 • Number of events 3 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Respiratory, thoracic and mediastinal disorders Cough	28.6% 8/28 • Number of events 10 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	16.1% 9/56 • Number of events 10 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	4.0% 1/25 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	2.0% 1/49 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.1% 2/28 • Number of events 2 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/56 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	14.3% 4/28 • Number of events 6 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	8.9% 5/56 • Number of events 9 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	4.0% 1/25 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	2.0% 1/49 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	3.6% 1/28 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	14.3% 8/56 • Number of events 8 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	2.0% 1/49 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Skin and subcutaneous tissue disorders Urticaria	7.1% 2/28 • Number of events 2 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	1.8% 1/56 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	4.0% 1/25 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/5 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Infections and infestations Viral Infection	0.00% 0/28 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/56 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	20.0% 1/5 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
General disorders Medical device site pain	0.00% 0/28 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/56 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	20.0% 1/5 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Respiratory, thoracic and mediastinal disorders Throat tightness	0.00% 0/28 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/56 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	20.0% 1/5 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.
Gastrointestinal disorders Dyspepsia	0.00% 0/28 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/56 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/25 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	0.00% 0/49 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.	20.0% 1/5 • Number of events 1 • Up to Week 52 (Active treatment period), From Week 52-104 (Off-therapy follow-up period), Open label extension (OLE) Week 0-60 after active treatment period (OLE period) The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent.

Additional Information

Senior Director Clinical Development

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER