Trial Outcomes & Findings for Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis (NCT NCT02969018)

Last Updated: 2019-03-29

Results Overview

The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. In each area, the sum of the severity rating scores for erythema, induration and scaling is multiplied by the score representing the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of the numbers obtained for each of the four body areas is the PASI. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

212 participants

Primary outcome timeframe

Baseline (Day 1 pre-dose), Week 12

Results posted on

2019-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 10 mg QD Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	PF-06700841 60 mg QD Followed by Placebo Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).	PF-06700841 30 mg QD Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.	PF-06700841 30 mg QD Followed by 10 mg QD Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 30 mg QD Followed by 100 mg QW Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	Placebo Participants received 12 weeks of blinded matching placebo QD tablets.
Overall Study STARTED	25	29	26	25	29	25	30	23
Overall Study COMPLETED	21	21	20	20	27	17	22	16
Overall Study NOT COMPLETED	4	8	6	5	2	8	8	7

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 10 mg QD Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	PF-06700841 60 mg QD Followed by Placebo Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).	PF-06700841 30 mg QD Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.	PF-06700841 30 mg QD Followed by 10 mg QD Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 30 mg QD Followed by 100 mg QW Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	Placebo Participants received 12 weeks of blinded matching placebo QD tablets.
Overall Study Adverse Event	2	4	1	2	0	1	2	0
Overall Study Lack of Efficacy	0	1	0	0	1	1	1	1
Overall Study Lost to Follow-up	1	2	2	0	1	1	0	1
Overall Study No Longer Meets Eligibility Criteria	0	0	0	0	0	0	1	0
Overall Study Non-Compliance With Study Drug	1	0	0	0	0	0	0	0
Overall Study Other	0	0	0	1	0	0	0	2
Overall Study Pregnancy	0	0	0	0	0	1	0	0
Overall Study Protocol Violation	0	0	1	1	0	0	0	0
Overall Study Withdrawal by Subject	0	1	2	1	0	4	4	3

Baseline Characteristics

Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 10 mg QD n=29 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) n=26 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	PF-06700841 60 mg QD Followed by Placebo n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).	PF-06700841 30 mg QD n=29 Participants Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.	PF-06700841 30 mg QD Followed by 10 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 30 mg QD Followed by 100 mg QW n=30 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	Placebo n=23 Participants Participants received 12 weeks of blinded matching placebo QD tablets.	Total n=212 Participants Total of all reporting groups
Age, Continuous	49.0 years STANDARD_DEVIATION 14.69 • n=5 Participants	44.6 years STANDARD_DEVIATION 13.71 • n=7 Participants	45.5 years STANDARD_DEVIATION 12.93 • n=5 Participants	48.4 years STANDARD_DEVIATION 15.47 • n=4 Participants	44.2 years STANDARD_DEVIATION 10.92 • n=21 Participants	44.0 years STANDARD_DEVIATION 11.56 • n=10 Participants	43.2 years STANDARD_DEVIATION 12.28 • n=115 Participants	50.3 years STANDARD_DEVIATION 12.23 • n=24 Participants	46.0 years STANDARD_DEVIATION 13.04 • n=42 Participants
Age, Customized 18-44 Years	8 Participants n=5 Participants	14 Participants n=7 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	14 Participants n=21 Participants	12 Participants n=10 Participants	14 Participants n=115 Participants	8 Participants n=24 Participants	88 Participants n=42 Participants
Age, Customized 45-64 Years	14 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants	13 Participants n=4 Participants	14 Participants n=21 Participants	13 Participants n=10 Participants	16 Participants n=115 Participants	12 Participants n=24 Participants	109 Participants n=42 Participants
Age, Customized >=65 Years	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=24 Participants	15 Participants n=42 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants	4 Participants n=4 Participants	10 Participants n=21 Participants	8 Participants n=10 Participants	7 Participants n=115 Participants	4 Participants n=24 Participants	64 Participants n=42 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	21 Participants n=7 Participants	12 Participants n=5 Participants	21 Participants n=4 Participants	19 Participants n=21 Participants	17 Participants n=10 Participants	23 Participants n=115 Participants	19 Participants n=24 Participants	148 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants	5 Participants n=10 Participants	4 Participants n=115 Participants	4 Participants n=24 Participants	33 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	25 Participants n=7 Participants	22 Participants n=5 Participants	23 Participants n=4 Participants	23 Participants n=21 Participants	20 Participants n=10 Participants	26 Participants n=115 Participants	19 Participants n=24 Participants	179 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized White	22 Participants n=5 Participants	27 Participants n=7 Participants	23 Participants n=5 Participants	24 Participants n=4 Participants	27 Participants n=21 Participants	22 Participants n=10 Participants	25 Participants n=115 Participants	19 Participants n=24 Participants	189 Participants n=42 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=24 Participants	11 Participants n=42 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants	0 Participants n=24 Participants	4 Participants n=42 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	3 Participants n=42 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=24 Participants	3 Participants n=42 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1 pre-dose), Week 12

Population: All randomized participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had observed PASI data for Week 12.

Outcome measures

Outcome measures
Measure	PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD n=22 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 10 mg QD n=21 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) n=21 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	PF-06700841 60 mg QD Followed by Placebo n=21 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).	PF-06700841 30 mg QD n=27 Participants Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.	PF-06700841 30 mg QD Followed by 10 mg QD n=19 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 30 mg QD Followed by 100 mg QW n=25 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	Placebo n=17 Participants Participants received 12 weeks of blinded matching placebo QD tablets.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12	-15.85 units on a scale Interval -18.31 to -13.39	-10.56 units on a scale Interval -12.96 to -8.16	-14.28 units on a scale Interval -16.75 to -11.81	-10.14 units on a scale Interval -12.62 to -7.66	-17.28 units on a scale Interval -19.55 to -15.02	-13.27 units on a scale Interval -15.78 to -10.76	-11.88 units on a scale Interval -14.16 to -9.59	-7.21 units on a scale Interval -9.96 to -4.46

SECONDARY outcome

Timeframe: Week 12

Population: All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data at Week 12 after non-responder imputation applied.

A PASI75 response is a 75% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

Outcome measures

Outcome measures
Measure	PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 10 mg QD n=29 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) n=26 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	PF-06700841 60 mg QD Followed by Placebo n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).	PF-06700841 30 mg QD n=29 Participants Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.	PF-06700841 30 mg QD Followed by 10 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 30 mg QD Followed by 100 mg QW n=30 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	Placebo n=23 Participants Participants received 12 weeks of blinded matching placebo QD tablets.
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12	60.0 percentage of participants Interval 41.68 to 76.44	24.1 percentage of participants Interval 11.92 to 40.6	57.7 percentage of participants Interval 39.84 to 74.16	24.0 percentage of participants Interval 11.01 to 41.95	86.2 percentage of participants Interval 71.16 to 95.15	24.0 percentage of participants Interval 11.01 to 41.95	36.7 percentage of participants Interval 22.11 to 53.31	13.0 percentage of participants Interval 3.65 to 30.36

SECONDARY outcome

Timeframe: Baseline (Day 1 pre-dose), Week 4

Population: All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had observed PASI data at Week 4.

Change from baseline in PASI scores at Week 4 was presented by induction dose (ie, PF-06700841 60 mg QD, 30 mg QD, and placebo). The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

Outcome measures

Outcome measures
Measure	PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD n=100 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 10 mg QD n=81 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) n=21 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	PF-06700841 60 mg QD Followed by Placebo Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).	PF-06700841 30 mg QD Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.	PF-06700841 30 mg QD Followed by 10 mg QD Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 30 mg QD Followed by 100 mg QW Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	Placebo Participants received 12 weeks of blinded matching placebo QD tablets.
Change From Baseline in PASI Scores at Week 4 by Induction Dose	-13.17 units on a scale Interval -14.2 to -12.15	-12.16 units on a scale Interval -13.31 to -11.02	-4.17 units on a scale Interval -6.38 to -1.97	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 6, 8, 10, 14, 16

Population: All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data for each specified time point after non-responder imputation applied.

Outcome measures

Outcome measures
Measure	PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 10 mg QD n=29 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) n=26 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	PF-06700841 60 mg QD Followed by Placebo n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).	PF-06700841 30 mg QD n=29 Participants Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.	PF-06700841 30 mg QD Followed by 10 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 30 mg QD Followed by 100 mg QW n=30 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	Placebo n=23 Participants Participants received 12 weeks of blinded matching placebo QD tablets.
Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16 Week 1	0 percentage of participants Interval 0.0 to 11.29	6.9 percentage of participants Interval 1.24 to 20.16	7.7 percentage of participants Interval 1.38 to 22.29	4.0 percentage of participants Interval 0.2 to 17.61	0 percentage of participants Interval 0.0 to 9.81	4.0 percentage of participants Interval 0.2 to 17.61	0 percentage of participants Interval 0.0 to 9.5	0 percentage of participants Interval 0.0 to 12.21
Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16 Week 2	8.0 percentage of participants Interval 1.44 to 23.1	13.8 percentage of participants Interval 4.85 to 28.84	26.9 percentage of participants Interval 13.38 to 44.68	12.0 percentage of participants Interval 3.35 to 28.17	3.4 percentage of participants Interval 0.18 to 15.34	8.0 percentage of participants Interval 1.44 to 23.1	0 percentage of participants Interval 0.0 to 9.5	0 percentage of participants Interval 0.0 to 12.21
Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16 Week 4	24.0 percentage of participants Interval 11.01 to 41.95	41.4 percentage of participants Interval 25.89 to 58.25	61.5 percentage of participants Interval 43.57 to 77.43	36.0 percentage of participants Interval 20.24 to 54.39	27.6 percentage of participants Interval 14.53 to 44.29	24.0 percentage of participants Interval 11.01 to 41.95	36.7 percentage of participants Interval 22.11 to 53.31	0 percentage of participants Interval 0.0 to 12.21
Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16 Week 6	44.0 percentage of participants Interval 26.99 to 62.14	41.4 percentage of participants Interval 25.89 to 58.25	65.4 percentage of participants Interval 47.38 to 80.6	36.0 percentage of participants Interval 20.24 to 54.39	51.7 percentage of participants Interval 35.2 to 67.97	28.0 percentage of participants Interval 13.95 to 46.22	26.7 percentage of participants Interval 14.02 to 42.99	8.7 percentage of participants Interval 1.57 to 24.92
Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16 Week 8	60.0 percentage of participants Interval 41.68 to 76.44	37.9 percentage of participants Interval 22.93 to 54.88	65.4 percentage of participants Interval 47.38 to 80.6	32.0 percentage of participants Interval 17.03 to 50.36	65.5 percentage of participants Interval 48.57 to 79.95	20.0 percentage of participants Interval 8.23 to 37.54	40.0 percentage of participants Interval 24.95 to 56.61	8.7 percentage of participants Interval 1.57 to 24.92
Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16 Week 10	48.0 percentage of participants Interval 30.51 to 65.86	24.1 percentage of participants Interval 11.92 to 40.6	61.5 percentage of participants Interval 43.57 to 77.43	32.0 percentage of participants Interval 17.03 to 50.36	72.4 percentage of participants Interval 55.71 to 85.47	28.0 percentage of participants Interval 13.95 to 46.22	46.7 percentage of participants Interval 30.85 to 63.01	13.0 percentage of participants Interval 3.65 to 30.36
Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16 Week 14	48.0 percentage of participants Interval 30.51 to 65.86	17.2 percentage of participants Interval 7.05 to 32.89	34.6 percentage of participants Interval 19.4 to 52.62	16.0 percentage of participants Interval 5.66 to 32.96	75.9 percentage of participants Interval 59.4 to 88.08	16.0 percentage of participants Interval 5.66 to 32.96	16.7 percentage of participants Interval 6.81 to 31.9	8.7 percentage of participants Interval 1.57 to 24.92
Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16 Week 16	36.0 percentage of participants Interval 20.24 to 54.39	10.3 percentage of participants Interval 2.88 to 24.61	30.8 percentage of participants Interval 16.33 to 48.7	20.0 percentage of participants Interval 8.23 to 37.54	58.6 percentage of participants Interval 41.75 to 74.11	12.0 percentage of participants Interval 3.35 to 28.17	16.7 percentage of participants Interval 6.81 to 31.9	8.7 percentage of participants Interval 1.57 to 24.92

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16

Population: All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data for each specified time point after non-responder imputation applied.

A PASI50 response is a 50% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

Outcome measures

Outcome measures
Measure	PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 10 mg QD n=29 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) n=26 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	PF-06700841 60 mg QD Followed by Placebo n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).	PF-06700841 30 mg QD n=29 Participants Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.	PF-06700841 30 mg QD Followed by 10 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 30 mg QD Followed by 100 mg QW n=30 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	Placebo n=23 Participants Participants received 12 weeks of blinded matching placebo QD tablets.
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 1	12.0 percentage of participants Interval 3.35 to 28.17	13.8 percentage of participants Interval 4.85 to 28.84	19.2 percentage of participants Interval 7.9 to 36.26	20.0 percentage of participants Interval 8.23 to 37.54	10.3 percentage of participants Interval 2.88 to 24.61	8.0 percentage of participants Interval 1.44 to 23.1	3.3 percentage of participants Interval 0.17 to 14.86	0 percentage of participants Interval 0.0 to 12.21
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 2	44.0 percentage of participants Interval 26.99 to 62.14	37.9 percentage of participants Interval 22.93 to 54.88	46.2 percentage of participants Interval 29.21 to 63.79	32.0 percentage of participants Interval 17.03 to 50.36	41.4 percentage of participants Interval 25.89 to 58.25	20.0 percentage of participants Interval 8.23 to 37.54	33.3 percentage of participants Interval 19.33 to 49.94	0 percentage of participants Interval 0.0 to 12.21
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 4	60.0 percentage of participants Interval 41.68 to 76.44	69.0 percentage of participants Interval 52.1 to 82.75	69.2 percentage of participants Interval 51.3 to 83.67	68.0 percentage of participants Interval 49.64 to 82.97	69.0 percentage of participants Interval 52.1 to 82.75	60.0 percentage of participants Interval 41.68 to 76.44	66.7 percentage of participants Interval 50.06 to 80.67	13.0 percentage of participants Interval 3.65 to 30.36
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 6	72.0 percentage of participants Interval 53.78 to 86.05	62.1 percentage of participants Interval 45.12 to 77.07	73.1 percentage of participants Interval 55.32 to 86.62	68.0 percentage of participants Interval 49.64 to 82.97	82.8 percentage of participants Interval 67.11 to 92.95	60.0 percentage of participants Interval 41.68 to 76.44	63.3 percentage of participants Interval 46.69 to 77.89	26.1 percentage of participants Interval 12.02 to 45.1
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 8	72.0 percentage of participants Interval 53.78 to 86.05	55.2 percentage of participants Interval 38.44 to 71.07	73.1 percentage of participants Interval 55.32 to 86.62	52.0 percentage of participants Interval 34.14 to 69.49	86.2 percentage of participants Interval 71.16 to 95.15	56.0 percentage of participants Interval 37.86 to 73.01	63.3 percentage of participants Interval 46.69 to 77.89	17.4 percentage of participants Interval 6.17 to 35.49
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 10	68.0 percentage of participants Interval 49.64 to 82.97	44.8 percentage of participants Interval 28.93 to 61.56	73.1 percentage of participants Interval 55.32 to 86.62	48.0 percentage of participants Interval 30.51 to 65.86	86.2 percentage of participants Interval 71.16 to 95.15	48.0 percentage of participants Interval 30.51 to 65.86	56.7 percentage of participants Interval 40.16 to 72.13	17.4 percentage of participants Interval 6.17 to 35.49
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 12	68.0 percentage of participants Interval 49.64 to 82.97	44.8 percentage of participants Interval 28.93 to 61.56	69.2 percentage of participants Interval 51.3 to 83.67	52.0 percentage of participants Interval 34.14 to 69.49	89.7 percentage of participants Interval 75.39 to 97.12	48.0 percentage of participants Interval 30.51 to 65.86	53.3 percentage of participants Interval 36.99 to 69.15	21.7 percentage of participants Interval 8.98 to 40.39
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 14	64.0 percentage of participants Interval 45.61 to 79.76	44.8 percentage of participants Interval 28.93 to 61.56	61.5 percentage of participants Interval 43.57 to 77.43	48.0 percentage of participants Interval 30.51 to 65.86	89.7 percentage of participants Interval 75.39 to 97.12	36.0 percentage of participants Interval 20.24 to 54.39	36.7 percentage of participants Interval 22.11 to 53.31	26.1 percentage of participants Interval 12.02 to 45.1
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 16	60.0 percentage of participants Interval 41.68 to 76.44	34.5 percentage of participants Interval 20.05 to 51.43	53.8 percentage of participants Interval 36.21 to 70.79	40.0 percentage of participants Interval 23.56 to 58.32	79.3 percentage of participants Interval 63.2 to 90.58	40.0 percentage of participants Interval 23.56 to 58.32	36.7 percentage of participants Interval 22.11 to 53.31	21.7 percentage of participants Interval 8.98 to 40.39

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16

Population: All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data for each specified time point after non-responder imputation applied.

A PASI90 response is a 90% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

Outcome measures

Outcome measures
Measure	PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 10 mg QD n=29 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) n=26 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	PF-06700841 60 mg QD Followed by Placebo n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).	PF-06700841 30 mg QD n=29 Participants Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.	PF-06700841 30 mg QD Followed by 10 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 30 mg QD Followed by 100 mg QW n=30 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	Placebo n=23 Participants Participants received 12 weeks of blinded matching placebo QD tablets.
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 1	0 percentage of participants Interval 0.0 to 11.29	3.4 percentage of participants Interval 0.18 to 15.34	0 percentage of participants Interval 0.0 to 10.88	0 percentage of participants Interval 0.0 to 11.29	0 percentage of participants Interval 0.0 to 9.81	0 percentage of participants Interval 0.0 to 11.29	0 percentage of participants Interval 0.0 to 9.5	0 percentage of participants Interval 0.0 to 12.21
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 2	0 percentage of participants Interval 0.0 to 11.29	3.4 percentage of participants Interval 0.18 to 15.34	7.7 percentage of participants Interval 1.38 to 22.29	0 percentage of participants Interval 0.0 to 11.29	0 percentage of participants Interval 0.0 to 9.81	0 percentage of participants Interval 0.0 to 11.29	0 percentage of participants Interval 0.0 to 9.5	0 percentage of participants Interval 0.0 to 12.21
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 4	12.0 percentage of participants Interval 3.35 to 28.17	20.7 percentage of participants Interval 9.42 to 36.8	42.3 percentage of participants Interval 25.84 to 60.16	16.0 percentage of participants Interval 5.66 to 32.96	6.9 percentage of participants Interval 1.24 to 20.16	8.0 percentage of participants Interval 1.44 to 23.1	3.3 percentage of participants Interval 0.17 to 14.86	0 percentage of participants Interval 0.0 to 12.21
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 6	16.0 percentage of participants Interval 5.66 to 32.96	20.7 percentage of participants Interval 9.42 to 36.8	26.9 percentage of participants Interval 13.38 to 44.68	12.0 percentage of participants Interval 3.35 to 28.17	24.1 percentage of participants Interval 11.92 to 40.6	8.0 percentage of participants Interval 1.44 to 23.1	20.0 percentage of participants Interval 9.09 to 35.7	0 percentage of participants Interval 0.0 to 12.21
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 8	24.0 percentage of participants Interval 11.01 to 41.95	17.2 percentage of participants Interval 7.05 to 32.89	30.8 percentage of participants Interval 16.33 to 48.7	8.0 percentage of participants Interval 1.44 to 23.1	34.5 percentage of participants Interval 20.05 to 51.43	4.0 percentage of participants Interval 0.2 to 17.61	16.7 percentage of participants Interval 6.81 to 31.9	0 percentage of participants Interval 0.0 to 12.21
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 10	28.0 percentage of participants Interval 13.95 to 46.22	17.2 percentage of participants Interval 7.05 to 32.89	26.9 percentage of participants Interval 13.38 to 44.68	8.0 percentage of participants Interval 1.44 to 23.1	34.5 percentage of participants Interval 20.05 to 51.43	8.0 percentage of participants Interval 1.44 to 23.1	13.3 percentage of participants Interval 4.69 to 27.96	4.3 percentage of participants Interval 0.22 to 19.02
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 12	36.0 percentage of participants Interval 20.24 to 54.39	13.8 percentage of participants Interval 4.85 to 28.84	26.9 percentage of participants Interval 13.38 to 44.68	8.0 percentage of participants Interval 1.44 to 23.1	51.7 percentage of participants Interval 35.2 to 67.97	8.0 percentage of participants Interval 1.44 to 23.1	10.0 percentage of participants Interval 2.78 to 23.86	4.3 percentage of participants Interval 0.22 to 19.02
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 14	28.0 percentage of participants Interval 13.95 to 46.22	13.8 percentage of participants Interval 4.85 to 28.84	11.5 percentage of participants Interval 3.22 to 27.19	8.0 percentage of participants Interval 1.44 to 23.1	37.9 percentage of participants Interval 22.93 to 54.88	4.0 percentage of participants Interval 0.2 to 17.61	13.3 percentage of participants Interval 4.69 to 27.96	4.3 percentage of participants Interval 0.22 to 19.02
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 16	20.0 percentage of participants Interval 8.23 to 37.54	3.4 percentage of participants Interval 0.18 to 15.34	15.4 percentage of participants Interval 5.43 to 31.82	4.0 percentage of participants Interval 0.2 to 17.61	27.6 percentage of participants Interval 14.53 to 44.29	8.0 percentage of participants Interval 1.44 to 23.1	10.0 percentage of participants Interval 2.78 to 23.86	4.3 percentage of participants Interval 0.22 to 19.02

SECONDARY outcome

Timeframe: Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 14, 16

Population: "Number of participants analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo). "Number analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had observed PASI data for each specified time point.

The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

Outcome measures

Outcome measures
Measure	PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 10 mg QD n=29 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) n=26 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	PF-06700841 60 mg QD Followed by Placebo n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).	PF-06700841 30 mg QD n=29 Participants Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.	PF-06700841 30 mg QD Followed by 10 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 30 mg QD Followed by 100 mg QW n=30 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	Placebo n=23 Participants Participants received 12 weeks of blinded matching placebo QD tablets.
Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16 Week 1	-5.74 units on a scale Interval -7.61 to -3.86	-4.60 units on a scale Interval -6.06 to -3.14	-5.85 units on a scale Interval -7.62 to -4.08	-5.37 units on a scale Interval -7.59 to -3.15	-3.97 units on a scale Interval -5.0 to -2.95	-4.41 units on a scale Interval -6.18 to -2.64	-3.46 units on a scale Interval -4.64 to -2.28	-1.35 units on a scale Interval -2.03 to -0.66
Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16 Week 2	-9.44 units on a scale Interval -11.74 to -7.15	-8.35 units on a scale Interval -10.07 to -6.63	-10.79 units on a scale Interval -13.05 to -8.52	-9.49 units on a scale Interval -12.4 to -6.58	-7.86 units on a scale Interval -9.38 to -6.35	-7.79 units on a scale Interval -9.79 to -5.79	-7.93 units on a scale Interval -9.64 to -6.22	-2.28 units on a scale Interval -3.21 to -1.36
Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16 Week 4	-12.85 units on a scale Interval -15.76 to -9.94	-12.19 units on a scale Interval -14.57 to -9.81	-14.11 units on a scale Interval -16.37 to -11.86	-13.91 units on a scale Interval -16.98 to -10.85	-11.72 units on a scale Interval -13.61 to -9.83	-12.88 units on a scale Interval -15.49 to -10.27	-13.06 units on a scale Interval -15.58 to -10.53	-4.02 units on a scale Interval -6.04 to -2.0
Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16 Week 6	-15.00 units on a scale Interval -18.3 to -11.71	-12.12 units on a scale Interval -14.53 to -9.71	-15.00 units on a scale Interval -17.35 to -12.66	-13.85 units on a scale Interval -16.62 to -11.08	-14.30 units on a scale Interval -16.24 to -12.36	-14.33 units on a scale Interval -17.47 to -11.19	-14.17 units on a scale Interval -16.92 to -11.41	-5.52 units on a scale Interval -7.58 to -3.45
Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16 Week 8	-15.94 units on a scale Interval -19.4 to -12.49	-11.09 units on a scale Interval -12.9 to -9.27	-14.97 units on a scale Interval -17.66 to -12.27	-12.87 units on a scale Interval -15.69 to -10.04	-15.82 units on a scale Interval -17.81 to -13.84	-14.27 units on a scale Interval -17.51 to -11.03	-13.83 units on a scale Interval -16.79 to -10.87	-6.56 units on a scale Interval -8.61 to -4.51
Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16 Week 10	-16.54 units on a scale Interval -20.54 to -12.54	-9.89 units on a scale Interval -12.16 to -7.61	-15.52 units on a scale Interval -18.09 to -12.96	-11.64 units on a scale Interval -14.92 to -8.37	-16.65 units on a scale Interval -18.64 to -14.66	-14.98 units on a scale Interval -18.43 to -11.53	-12.97 units on a scale Interval -16.19 to -9.74	-6.78 units on a scale Interval -9.2 to -4.37
Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16 Week 14	-15.47 units on a scale Interval -19.88 to -11.06	-8.11 units on a scale Interval -10.69 to -5.53	-13.31 units on a scale Interval -16.73 to -9.89	-9.45 units on a scale Interval -12.96 to -5.94	-16.14 units on a scale Interval -18.16 to -14.12	-10.44 units on a scale Interval -13.33 to -7.55	-11.03 units on a scale Interval -14.61 to -7.44	-6.98 units on a scale Interval -9.81 to -4.14
Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16 Week 16	-14.16 units on a scale Interval -18.68 to -9.64	-6.59 units on a scale Interval -9.09 to -4.09	-13.00 units on a scale Interval -16.6 to -9.4	-7.83 units on a scale Interval -11.56 to -4.11	-14.38 units on a scale Interval -16.74 to -12.01	-9.62 units on a scale Interval -13.08 to -6.16	-9.13 units on a scale Interval -13.94 to -4.33	-6.76 units on a scale Interval -9.8 to -3.72

SECONDARY outcome

Timeframe: Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16

The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.

Outcome measures

Outcome measures
Measure	PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 10 mg QD n=29 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) n=26 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	PF-06700841 60 mg QD Followed by Placebo n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).	PF-06700841 30 mg QD n=29 Participants Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.	PF-06700841 30 mg QD Followed by 10 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 30 mg QD Followed by 100 mg QW n=30 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	Placebo n=23 Participants Participants received 12 weeks of blinded matching placebo QD tablets.
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 16	-57.28 percent change Interval -72.02 to -42.54	-38.48 percent change Interval -51.85 to -25.1	-60.56 percent change Interval -72.71 to -48.42	-36.63 percent change Interval -51.43 to -21.83	-74.18 percent change Interval -83.22 to -65.15	-44.58 percent change Interval -58.96 to -30.19	-42.29 percent change Interval -59.96 to -24.63	-38.79 percent change Interval -51.92 to -25.66
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 1	-26.70 percent change Interval -33.8 to -19.6	-24.66 percent change Interval -33.24 to -16.08	-30.25 percent change Interval -39.07 to -21.44	-23.33 percent change Interval -30.84 to -15.82	-20.92 percent change Interval -26.82 to -15.01	-17.50 percent change Interval -23.91 to -11.1	-15.42 percent change Interval -20.68 to -10.16	-6.90 percent change Interval -10.5 to -3.3
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 2	-43.66 percent change Interval -52.81 to -34.52	-44.17 percent change Interval -52.75 to -35.59	-54.27 percent change Interval -64.17 to -44.36	-42.58 percent change Interval -51.17 to -33.98	-40.89 percent change Interval -47.94 to -33.83	-32.46 percent change Interval -39.75 to -25.16	-35.89 percent change Interval -42.69 to -29.09	-12.81 percent change Interval -18.29 to -7.33
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 4	-57.16 percent change Interval -67.35 to -46.97	-63.02 percent change Interval -72.12 to -53.91	-72.41 percent change Interval -82.31 to -62.51	-64.71 percent change Interval -72.81 to -56.61	-60.76 percent change Interval -68.38 to -53.14	-53.93 percent change Interval -62.59 to -45.28	-58.99 percent change Interval -67.94 to -50.03	-25.17 percent change Interval -34.24 to -16.09
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 6	-66.07 percent change Interval -76.06 to -56.08	-63.31 percent change Interval -73.99 to -52.62	-75.96 percent change Interval -84.68 to -67.25	-65.06 percent change Interval -74.15 to -55.97	-73.91 percent change Interval -80.62 to -67.19	-58.57 percent change Interval -66.76 to -50.37	-63.17 percent change Interval -72.37 to -53.96	-33.49 percent change Interval -44.16 to -22.83
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 8	-70.11 percent change Interval -80.95 to -59.27	-62.25 percent change Interval -72.42 to -52.07	-77.05 percent change Interval -86.69 to -67.41	-59.88 percent change Interval -69.78 to -49.97	-81.04 percent change Interval -86.69 to -75.4	-58.32 percent change Interval -66.39 to -50.25	-61.38 percent change Interval -71.8 to -50.96	-37.76 percent change Interval -47.73 to -27.8
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 10	-70.72 percent change Interval -83.32 to -58.12	-57.55 percent change Interval -69.11 to -46.0	-78.46 percent change Interval -85.82 to -71.09	-53.81 percent change Interval -64.41 to -43.22	-84.82 percent change Interval -89.5 to -80.15	-61.23 percent change Interval -69.29 to -53.17	-57.24 percent change Interval -68.8 to -45.69	-39.68 percent change Interval -50.92 to -28.44
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 12	-71.94 percent change Interval -84.67 to -59.21	-58.52 percent change Interval -69.38 to -47.67	-74.42 percent change Interval -84.98 to -63.87	-51.49 percent change Interval -63.21 to -39.78	-88.68 percent change Interval -93.13 to -84.22	-57.81 percent change Interval -68.52 to -47.1	-58.57 percent change Interval -70.05 to -47.09	-40.27 percent change Interval -52.68 to -27.86
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 Week 14	-64.15 percent change Interval -78.24 to -50.05	-47.87 percent change Interval -62.17 to -33.56	-63.20 percent change Interval -74.36 to -52.05	-44.30 percent change Interval -57.51 to -31.09	-83.39 percent change Interval -89.74 to -77.04	-47.84 percent change Interval -60.18 to -35.49	-47.52 percent change Interval -59.86 to -35.18	-39.48 percent change Interval -52.09 to -26.88

SECONDARY outcome

Timeframe: From first dose of study treatment (Day 1) up to Week 20

Population: All participants who received at least 1 dose of investigational product (PF-06700841 or placebo).

An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or an important medical event. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.

Outcome measures

Outcome measures
Measure	PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 10 mg QD n=29 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) n=26 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	PF-06700841 60 mg QD Followed by Placebo n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).	PF-06700841 30 mg QD n=29 Participants Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.	PF-06700841 30 mg QD Followed by 10 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 30 mg QD Followed by 100 mg QW n=30 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	Placebo n=23 Participants Participants received 12 weeks of blinded matching placebo QD tablets.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Treatment-emergent AEs	19 Participants	21 Participants	18 Participants	18 Participants	21 Participants	16 Participants	23 Participants	13 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Treatment-emergent SAEs	2 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose of study treatment (Day 1) up to Week 20

Population: All participants who received at least 1 dose of investigational product (PF-06700841 or placebo).

The number of participants who discontinued from the study due to treatment-emergent AEs is presented. Note for data reported under this Outcome Measure: Per sponsor reporting standard, pregnancy was counted as AE for AE data tables while it was counted separately in the disposition data table (Participant Flow Module).

Outcome measures

Outcome measures
Measure	PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 10 mg QD n=29 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) n=26 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	PF-06700841 60 mg QD Followed by Placebo n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).	PF-06700841 30 mg QD n=29 Participants Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.	PF-06700841 30 mg QD Followed by 10 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 30 mg QD Followed by 100 mg QW n=30 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	Placebo n=23 Participants Participants received 12 weeks of blinded matching placebo QD tablets.
Number of Participants Who Discontinued From the Study Due to Treatment-Emergent AEs	2 Participants	4 Participants	1 Participants	2 Participants	0 Participants	2 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1 pre-dose), Weeks 4 and 12

Lipid panel included low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, total cholesterol, and triglycerides.

Outcome measures

Outcome measures
Measure	PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 10 mg QD n=29 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) n=26 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	PF-06700841 60 mg QD Followed by Placebo n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).	PF-06700841 30 mg QD n=29 Participants Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.	PF-06700841 30 mg QD Followed by 10 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 30 mg QD Followed by 100 mg QW n=30 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	Placebo n=23 Participants Participants received 12 weeks of blinded matching placebo QD tablets.
Change From Baseline in Blood Lipid Level at Weeks 4 and 12 Triglycerides, Week 4	34.74 milligram per deciliter (mg/dL) Interval -8.43 to 77.91	29.68 milligram per deciliter (mg/dL) Interval 10.42 to 48.94	8.04 milligram per deciliter (mg/dL) Interval -20.07 to 36.15	8.92 milligram per deciliter (mg/dL) Interval -21.83 to 39.66	-65.11 milligram per deciliter (mg/dL) Interval -204.94 to 74.72	19.60 milligram per deciliter (mg/dL) Interval -3.04 to 42.24	-59.75 milligram per deciliter (mg/dL) Interval -157.79 to 38.29	15.26 milligram per deciliter (mg/dL) Interval -11.07 to 41.6
Change From Baseline in Blood Lipid Level at Weeks 4 and 12 LDL Cholesterol, Week 4	15.91 milligram per deciliter (mg/dL) Interval 7.95 to 23.86	11.27 milligram per deciliter (mg/dL) Interval 4.31 to 18.23	15.00 milligram per deciliter (mg/dL) Interval -0.63 to 30.63	15.88 milligram per deciliter (mg/dL) Interval 6.63 to 25.12	8.96 milligram per deciliter (mg/dL) Interval 0.99 to 16.92	-2.21 milligram per deciliter (mg/dL) Interval -11.04 to 6.63	7.60 milligram per deciliter (mg/dL) Interval -4.39 to 19.59	-6.28 milligram per deciliter (mg/dL) Interval -10.56 to -2.0
Change From Baseline in Blood Lipid Level at Weeks 4 and 12 LDL Cholesterol, Week 12	8.71 milligram per deciliter (mg/dL) Interval 1.04 to 16.39	6.00 milligram per deciliter (mg/dL) Interval -4.73 to 16.73	-0.74 milligram per deciliter (mg/dL) Interval -11.67 to 10.2	6.85 milligram per deciliter (mg/dL) Interval -2.06 to 15.76	14.10 milligram per deciliter (mg/dL) Interval 6.63 to 21.57	-5.33 milligram per deciliter (mg/dL) Interval -18.24 to 7.57	3.95 milligram per deciliter (mg/dL) Interval -7.79 to 15.7	-4.00 milligram per deciliter (mg/dL) Interval -9.71 to 1.71
Change From Baseline in Blood Lipid Level at Weeks 4 and 12 HDL Cholesterol, Week 4	12.09 milligram per deciliter (mg/dL) Interval 8.07 to 16.11	9.14 milligram per deciliter (mg/dL) Interval 5.84 to 12.45	10.92 milligram per deciliter (mg/dL) Interval 7.38 to 14.46	8.58 milligram per deciliter (mg/dL) Interval 5.84 to 11.33	6.36 milligram per deciliter (mg/dL) Interval 3.91 to 8.8	6.76 milligram per deciliter (mg/dL) Interval 2.93 to 10.59	9.39 milligram per deciliter (mg/dL) Interval 7.03 to 11.75	0.00 milligram per deciliter (mg/dL) Interval -5.14 to 5.14
Change From Baseline in Blood Lipid Level at Weeks 4 and 12 HDL Cholesterol, Week 12	5.00 milligram per deciliter (mg/dL) Interval 1.29 to 8.71	5.48 milligram per deciliter (mg/dL) Interval 1.66 to 9.29	2.48 milligram per deciliter (mg/dL) Interval -0.31 to 5.26	-0.24 milligram per deciliter (mg/dL) Interval -2.55 to 2.08	4.74 milligram per deciliter (mg/dL) Interval 1.3 to 8.18	4.37 milligram per deciliter (mg/dL) Interval 1.04 to 7.7	2.88 milligram per deciliter (mg/dL) Interval -0.24 to 5.99	-2.73 milligram per deciliter (mg/dL) Interval -6.32 to 0.85
Change From Baseline in Blood Lipid Level at Weeks 4 and 12 Total Cholesterol, Week 4	34.39 milligram per deciliter (mg/dL) Interval 24.01 to 44.77	29.46 milligram per deciliter (mg/dL) Interval 18.68 to 40.25	31.32 milligram per deciliter (mg/dL) Interval 15.2 to 47.44	26.33 milligram per deciliter (mg/dL) Interval 15.85 to 36.82	15.14 milligram per deciliter (mg/dL) Interval -0.16 to 30.45	10.36 milligram per deciliter (mg/dL) Interval -1.7 to 22.42	14.00 milligram per deciliter (mg/dL) Interval 0.14 to 27.86	-4.42 milligram per deciliter (mg/dL) Interval -10.9 to 2.06
Change From Baseline in Blood Lipid Level at Weeks 4 and 12 Total Cholesterol, Week 12	19.50 milligram per deciliter (mg/dL) Interval 9.95 to 29.05	15.67 milligram per deciliter (mg/dL) Interval 2.74 to 28.59	-1.86 milligram per deciliter (mg/dL) Interval -13.78 to 10.07	7.05 milligram per deciliter (mg/dL) Interval -3.25 to 17.35	20.37 milligram per deciliter (mg/dL) Interval 3.06 to 37.68	0.68 milligram per deciliter (mg/dL) Interval -14.51 to 15.87	4.33 milligram per deciliter (mg/dL) Interval -8.86 to 17.53	-6.40 milligram per deciliter (mg/dL) Interval -13.68 to 0.88
Change From Baseline in Blood Lipid Level at Weeks 4 and 12 Triglycerides, Week 12	27.86 milligram per deciliter (mg/dL) Interval -4.68 to 60.41	48.33 milligram per deciliter (mg/dL) Interval -32.67 to 129.34	-85.00 milligram per deciliter (mg/dL) Interval -213.81 to 43.81	2.67 milligram per deciliter (mg/dL) Interval -27.36 to 32.7	-18.96 milligram per deciliter (mg/dL) Interval -198.51 to 160.59	6.32 milligram per deciliter (mg/dL) Interval -19.21 to 31.84	-67.79 milligram per deciliter (mg/dL) Interval -185.53 to 49.95	1.87 milligram per deciliter (mg/dL) Interval -24.28 to 28.01

SECONDARY outcome

Timeframe: From first dose of study treatment (Day 1) up to Week 16

Population: All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had post-baseline laboratory data.

Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time \[PT\], PT/international normalized ratio; chemistry (total bilirubin, direct bilirubin, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, total cholesterol, LDL and HDL cholesterol, triglycerides, calcium, sodium, potassium, chloride, bicarbonate, glucose, creatine kinase, Cystatin C, glomerular filtration rate; urinalysis (pH, urine glucose, ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, bacteria, choriogonadotropin beta).

Outcome measures

Outcome measures
Measure	PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 10 mg QD n=29 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	PF-06700841 60 mg QD Followed by Placebo n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).	PF-06700841 30 mg QD n=28 Participants Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.	PF-06700841 30 mg QD Followed by 10 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 30 mg QD Followed by 100 mg QW n=30 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	Placebo n=23 Participants Participants received 12 weeks of blinded matching placebo QD tablets.
Number of Participants With Any Post-Baseline Laboratory Test Abnormalities	17 Participants	20 Participants	20 Participants	16 Participants	21 Participants	20 Participants	18 Participants	11 Participants

SECONDARY outcome

Timeframe: From first dose of study treatment (Day 1) up to Week 16

Population: All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had post-baseline vital signs data.

Vital signs categorical summarization criteria: 1) sitting systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); 2) sitting diastolic blood pressure (DBP) \<50 mmHg; 3) sitting pulse rate \<40 or \>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in sitting DBP greater than or equal to (\>=) 20 mmHg; 5) change from baseline (increase or decrease) in sitting SBP \>=30 mmHg.

Outcome measures

Outcome measures
Measure	PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 10 mg QD n=29 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	PF-06700841 60 mg QD Followed by Placebo n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).	PF-06700841 30 mg QD n=28 Participants Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.	PF-06700841 30 mg QD Followed by 10 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 30 mg QD Followed by 100 mg QW n=30 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	Placebo n=23 Participants Participants received 12 weeks of blinded matching placebo QD tablets.
Number of Participants With Post-Baseline Vital Sign Abnormalities Sitting pulse rate <40 bpm	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Vital Sign Abnormalities Sitting DBP <50 mm Hg	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Vital Sign Abnormalities Sitting DBP increase >=20 mm Hg	1 Participants	1 Participants	3 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Vital Sign Abnormalities Sitting DBP decrease >=20 mm Hg	3 Participants	0 Participants	2 Participants	2 Participants	1 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Post-Baseline Vital Sign Abnormalities Sitting SBP <90 mm Hg	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Vital Sign Abnormalities Sitting SBP increase >=30 mm Hg	1 Participants	3 Participants	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Vital Sign Abnormalities Sitting SBP decrease >=30 mm Hg	2 Participants	2 Participants	1 Participants	2 Participants	1 Participants	3 Participants	2 Participants	1 Participants
Number of Participants With Post-Baseline Vital Sign Abnormalities Sitting pulse rate >120 bpm	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose of study treatment (Day 1) up to Week 16

Population: All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had post-baseline ECG data.

ECG categorical summarization criteria: 1) QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): \>=140 milliseconds (msec), \>=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): \>=300 msec, \>=25% change when baseline is \> 200 msec or \>=50% change when baseline is less than or equal to (\<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of \>=500 msec; 4) QTc interval (QT corrected for heart rate): absolute value of 450 to \<480 msec, 480 to \<500 msec, \>=500 msec; a change from baseline of 30 to \<60 msec or \>=60 msec.

Outcome measures

Outcome measures
Measure	PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD n=24 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 10 mg QD n=29 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	PF-06700841 60 mg QD Followed by Placebo n=25 Participants Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).	PF-06700841 30 mg QD n=28 Participants Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.	PF-06700841 30 mg QD Followed by 10 mg QD n=25 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 30 mg QD Followed by 100 mg QW n=28 Participants Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	Placebo n=22 Participants Participants received 12 weeks of blinded matching placebo QD tablets.
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities %Change in QRS duration >=50%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities QT interval >=500 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities QTc >=450 to <480 msec	6 Participants	1 Participants	2 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities QTc >=480 to <500 msec	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities QTc >=500 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities QTc change >=30 to <60 msec	2 Participants	0 Participants	2 Participants	1 Participants	3 Participants	3 Participants	0 Participants	1 Participants
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities QTc change >=60 msec	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities PR interval >=300 msec	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities %Change in PR interval >=25/50%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities QRS duration >=140 msec	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD

Serious events: 2 serious events

Other events: 11 other events

Deaths: 1 deaths

PF-06700841 60 mg QD Followed by 10 mg QD

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

PF-06700841 60 mg QD Followed by Placebo

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

PF-06700841 30 mg QD

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

PF-06700841 30 mg QD Followed by 10 mg QD

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

PF-06700841 30 mg QD Followed by 100 mg QW

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD n=25 participants at risk Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 10 mg QD n=29 participants at risk Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) n=26 participants at risk Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	PF-06700841 60 mg QD Followed by Placebo n=25 participants at risk Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).	PF-06700841 30 mg QD n=29 participants at risk Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.	PF-06700841 30 mg QD Followed by 10 mg QD n=25 participants at risk Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 30 mg QD Followed by 100 mg QW n=30 participants at risk Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	Placebo n=23 participants at risk Participants received 12 weeks of blinded matching placebo QD tablets.
Blood and lymphatic system disorders Anaemia	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.4% 1/29 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/26 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/30 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/23 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Cardiac disorders Angina pectoris	4.0% 1/25 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/26 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/30 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/23 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
General disorders Chest pain	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/26 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	4.0% 1/25 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/30 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/23 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Pneumonia	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.8% 1/26 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/30 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/23 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Sepsis	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.8% 1/26 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/30 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/23 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Gun shot wound	4.0% 1/25 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/26 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/30 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/23 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.

Other adverse events

Other adverse events
Measure	PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD n=25 participants at risk Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 10 mg QD n=29 participants at risk Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) n=26 participants at risk Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	PF-06700841 60 mg QD Followed by Placebo n=25 participants at risk Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).	PF-06700841 30 mg QD n=29 participants at risk Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.	PF-06700841 30 mg QD Followed by 10 mg QD n=25 participants at risk Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).	PF-06700841 30 mg QD Followed by 100 mg QW n=30 participants at risk Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).	Placebo n=23 participants at risk Participants received 12 weeks of blinded matching placebo QD tablets.
Nervous system disorders Headache	4.0% 1/25 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.9% 2/29 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	11.5% 3/26 • Number of events 3 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	12.0% 3/25 • Number of events 3 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	13.8% 4/29 • Number of events 6 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	4.0% 1/25 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/30 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	4.3% 1/23 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.4% 1/29 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	11.5% 3/26 • Number of events 3 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	4.0% 1/25 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	8.0% 2/25 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/30 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/23 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Diarrhoea	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.4% 1/29 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/26 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	4.0% 1/25 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	4.0% 1/25 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	10.0% 3/30 • Number of events 4 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	4.3% 1/23 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Nausea	4.0% 1/25 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.4% 1/29 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.8% 1/26 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	8.0% 2/25 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.3% 1/30 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	8.7% 2/23 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
General disorders Fatigue	4.0% 1/25 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.4% 1/29 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.8% 1/26 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	8.0% 2/25 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	4.0% 1/25 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/30 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	4.3% 1/23 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Upper respiratory tract infection	8.0% 2/25 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.4% 1/29 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	19.2% 5/26 • Number of events 5 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	4.0% 1/25 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.9% 2/29 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	10.0% 3/30 • Number of events 3 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	4.3% 1/23 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Cheilitis	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/26 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.9% 2/29 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/30 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/23 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.4% 1/29 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.8% 1/26 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	4.0% 1/25 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	8.0% 2/25 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/30 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/23 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Bronchitis	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.9% 2/29 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/26 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.9% 2/29 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/30 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/23 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Nasopharyngitis	16.0% 4/25 • Number of events 4 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	10.3% 3/29 • Number of events 4 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	11.5% 3/26 • Number of events 3 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	12.0% 3/25 • Number of events 3 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	17.2% 5/29 • Number of events 6 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	24.0% 6/25 • Number of events 6 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	13.3% 4/30 • Number of events 5 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	13.0% 3/23 • Number of events 3 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Sinusitis	4.0% 1/25 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.8% 1/26 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	8.0% 2/25 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.3% 1/30 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/23 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Urinary tract infection	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.4% 1/29 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.8% 1/26 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	4.0% 1/25 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.7% 2/30 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/23 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Vascular disorders Hot flush	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/26 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	8.0% 2/25 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/30 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/23 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.8% 1/26 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	12.0% 3/25 • Number of events 4 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.4% 1/29 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.3% 1/30 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/23 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Acne	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.9% 2/29 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/26 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	8.0% 2/25 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.7% 2/30 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/23 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.8% 1/26 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.9% 2/29 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/30 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/23 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Irritability	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/26 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	8.0% 2/25 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/30 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/23 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Back pain	4.0% 1/25 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.9% 2/29 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/26 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.9% 2/29 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	8.0% 2/25 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.3% 1/30 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	8.7% 2/23 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	4.0% 1/25 • Number of events 3 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.9% 2/29 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/26 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.4% 1/29 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	4.0% 1/25 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.3% 1/30 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	4.3% 1/23 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Investigations Neutrophil count decreased	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.8% 1/26 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	6.9% 2/29 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.3% 1/30 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/23 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	3.4% 1/29 • Number of events 1 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/26 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/25 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/29 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	8.0% 2/25 • Number of events 2 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/30 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/23 • From first dose of study treatment up to 20 weeks The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER