Trial Outcomes & Findings for Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects (NCT NCT03627767)

Last Updated: 2021-09-20

Results Overview

Percentage of participants with loss of response requiring rescue treatment during double blind period was determined. Loss of response denoted as flare and was define as a loss of at least 50% of EASI total score at Week 12 and with an IGA score of 2 or higher. EASI quantifies severity of participant's atopic dermatitis (AD) based on both severity of lesion clinical signs and % of body surface area (BSA) affected. EASI is a composite scoring by AD clinical evaluator of degree of erythema, induration/papulation, excoriation, and lichenification for each of 4 body regions. EASI total score range from 0.0 to 72.0, with higher scores representing greater severity of AD. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores = more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate and 4 = severe.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1235 participants

Primary outcome timeframe

From Day 1 of up to Week 40 of double blind period

Results posted on

2021-09-20

Participant Flow

Total 1235 participants were enrolled in 236 sites in 21 countries. Study started from 11 June 2018 and completed on 07 October 2020.

Study Baseline: was defined as the last observation collected on or prior to Day 1 (first dose day) of study treatment. Randomization Baseline: was defined as the last observation collected between last dose of run-in treatment and Day 1 (first dose day) of randomized treatment. Rescue Baseline: was defined as the last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment.

Participant milestones

Participant milestones
Measure	PF-04965842 200 mg OL Participants received 12 weeks induction treatment of 200 milligram (mg) oral tablets (each tablet of 100 mg) PF-04965842 once daily (QD) during an OL run-in period. Responders at the end of the 12-week OL run-in period entered the 40 week, double-blind (DB), maintenance treatment period. Responder criteria was defined as a) achieving an Investigator's Global Assessment (IGA) of clear (0) or almost clear (1) (on a 5-point scale), b) a reduction from IGA baseline of greater than or equal to (\>= 2) points, and c) reaching an Eczema Area and Severity Index (EASI)-75 response compared to baseline score. Baseline score was the IGA score and EASI score obtained prior to dosing on Day 1. Non-responders had a choice to enroll into the PF-04965842 Long Term Extension (LTE) study B7451015 (NCT03422822) otherwise, they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to Placebo DB Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg Rescue Period Participants who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during open-label Rescue Period for up to 12 weeks. After completing the 12-week rescue period, participants had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Participants who discontinued early from treatment, or who were otherwise ineligible for the LTE study, were followed-up for 4 week in this study.
Open-label (OL) Run-in Period (12 Weeks) STARTED	1235	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks) Treated	1233	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks) COMPLETED	798	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks) NOT COMPLETED	437	0	0	0	0
Double-blind Treatment Period (40 Weeks) STARTED	0	267	265	266	0
Double-blind Treatment Period (40 Weeks) Participants Entered Rescue Period	0	208	109	44	0
Double-blind Treatment Period (40 Weeks) Completed After Entering Rescue Period	0	201	99	41	0
Double-blind Treatment Period (40 Weeks) Completed Without Entering Rescue Period	0	43	134	187	0
Double-blind Treatment Period (40 Weeks) COMPLETED	0	251	243	231	0
Double-blind Treatment Period (40 Weeks) NOT COMPLETED	0	16	22	35	0
Open-label Rescue Period (12 Weeks) STARTED	0	0	0	0	361
Open-label Rescue Period (12 Weeks) Met Protocol-defined Flare Criteria	0	0	0	0	351
Open-label Rescue Period (12 Weeks) COMPLETED	0	0	0	0	341
Open-label Rescue Period (12 Weeks) NOT COMPLETED	0	0	0	0	20

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-04965842 200 mg OL Participants received 12 weeks induction treatment of 200 milligram (mg) oral tablets (each tablet of 100 mg) PF-04965842 once daily (QD) during an OL run-in period. Responders at the end of the 12-week OL run-in period entered the 40 week, double-blind (DB), maintenance treatment period. Responder criteria was defined as a) achieving an Investigator's Global Assessment (IGA) of clear (0) or almost clear (1) (on a 5-point scale), b) a reduction from IGA baseline of greater than or equal to (\>= 2) points, and c) reaching an Eczema Area and Severity Index (EASI)-75 response compared to baseline score. Baseline score was the IGA score and EASI score obtained prior to dosing on Day 1. Non-responders had a choice to enroll into the PF-04965842 Long Term Extension (LTE) study B7451015 (NCT03422822) otherwise, they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to Placebo DB Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg Rescue Period Participants who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during open-label Rescue Period for up to 12 weeks. After completing the 12-week rescue period, participants had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Participants who discontinued early from treatment, or who were otherwise ineligible for the LTE study, were followed-up for 4 week in this study.
Open-label (OL) Run-in Period (12 Weeks) Adverse Event	48	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks) Death	1	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks) Lack of Efficacy	315	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks) Lost to Follow-up	13	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks) Protocol Violation	11	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks) Withdrawal by Subject	40	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks) Medication Error Without Associated Adverse Event	1	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks) Withdrawal By Parent/Guardian	2	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks) Other	4	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks) Randomized but not treated	2	0	0	0	0
Double-blind Treatment Period (40 Weeks) Adverse Event	0	6	7	19	0
Double-blind Treatment Period (40 Weeks) Lost to Follow-up	0	0	2	3	0
Double-blind Treatment Period (40 Weeks) Protocol Violation	0	1	5	2	0
Double-blind Treatment Period (40 Weeks) Withdrawal by Subject	0	9	6	10	0
Double-blind Treatment Period (40 Weeks) Withdrawal By Parent/Guardian	0	0	1	0	0
Double-blind Treatment Period (40 Weeks) Other	0	0	1	1	0
Open-label Rescue Period (12 Weeks) Adverse Event	0	0	0	0	9
Open-label Rescue Period (12 Weeks) Lost to Follow-up	0	0	0	0	1
Open-label Rescue Period (12 Weeks) Withdrawal by Subject	0	0	0	0	9
Open-label Rescue Period (12 Weeks) Other	0	0	0	0	1

Baseline Characteristics

Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-04965842 200 mg OL to Placebo DB n=267 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=265 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=266 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	Total n=798 Participants Total of all reporting groups
Age, Customized <18 years	49 Participants n=93 Participants	49 Participants n=4 Participants	47 Participants n=27 Participants	145 Participants n=483 Participants
Age, Customized Between 18 and 65 years	210 Participants n=93 Participants	206 Participants n=4 Participants	207 Participants n=27 Participants	623 Participants n=483 Participants
Age, Customized >=65 years	8 Participants n=93 Participants	10 Participants n=4 Participants	12 Participants n=27 Participants	30 Participants n=483 Participants
Sex: Female, Male Female	126 Participants n=93 Participants	117 Participants n=4 Participants	116 Participants n=27 Participants	359 Participants n=483 Participants
Sex: Female, Male Male	141 Participants n=93 Participants	148 Participants n=4 Participants	150 Participants n=27 Participants	439 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	65 Participants n=93 Participants	62 Participants n=4 Participants	52 Participants n=27 Participants	179 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	200 Participants n=93 Participants	203 Participants n=4 Participants	214 Participants n=27 Participants	617 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	7 Participants n=483 Participants
Race (NIH/OMB) Asian	38 Participants n=93 Participants	41 Participants n=4 Participants	45 Participants n=27 Participants	124 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	14 Participants n=93 Participants	9 Participants n=4 Participants	10 Participants n=27 Participants	33 Participants n=483 Participants
Race (NIH/OMB) White	209 Participants n=93 Participants	208 Participants n=4 Participants	204 Participants n=27 Participants	621 Participants n=483 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants	10 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	3 Participants n=483 Participants

PRIMARY outcome

Timeframe: From Day 1 of up to Week 40 of double blind period

Population: Full analysis set-randomized (FAS-RA) included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Missing event times were considered as right censored (CAR) on last date of randomized treatment.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=267 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=265 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=266 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Percentage of Participants With Loss of Response: Double-blind (DB) Period	77.5 percentage of participants	39.6 percentage of participants	16.5 percentage of participants

PRIMARY outcome

Timeframe: From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window was extended +/- 45 Days due to COVID 19)

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Missing event times were considered as right censored (CAR) on last date of randomized treatment. Here 'Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.

Time (in days) to loss of response based on achieving IGA \>=2 was measured from date of first dose of randomized treatment until last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) and based on EASI, loss of at least 50% of EASI response at Week 12 and IGA score of 2 or higher. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores=more severity), reflecting global consideration of erythema, induration and scaling with scores 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. EASI composite score evaluates degree of erythema, induration/papulation, excoriation, and lichenification.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=207 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=105 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=44 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Time to Loss of Response: Double-blind Period	28.0 days Interval 28.0 to 29.0	323.0 days Interval 282.0 to 323.0	NA days Median and 95% CI were not estimable as there were only few participant who had events.

SECONDARY outcome

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least one dose of study medication within the double-blind phase. Missing event times were considered as right censored (CAR) on last date of randomized treatment. Here, Overall 'Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Time (in days) to loss of response based on achieving IGA \>=2 (for the first time) as measured from date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue). IGA assesses severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=247 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=183 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=145 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period	27.0 days 95% Confidence Interval 26.0 • Interval 26.0 to 28.0	78.0 days 95% Confidence Interval 32.0 • Interval 32.0 to 112.0	201.0 days 95% Confidence Interval 177.0 • Interval 177.0 to 282.0

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified time points.

IGA assessed severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep dark red lesions.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=267 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=264 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=266 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period Week 12	99.6 percentage of participants Interval 98.9 to 100.0	99.6 percentage of participants Interval 98.9 to 100.0	99.2 percentage of participants Interval 98.2 to 100.0
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period Week 16	15.4 percentage of participants Interval 11.0 to 19.7	55.5 percentage of participants Interval 49.5 to 61.5	77.8 percentage of participants Interval 72.8 to 82.8
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period Week 28	10.5 percentage of participants Interval 6.8 to 14.2	45.0 percentage of participants Interval 39.0 to 51.0	61.8 percentage of participants Interval 55.9 to 67.7
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period Week 40	10.6 percentage of participants Interval 6.9 to 14.3	42.3 percentage of participants Interval 36.3 to 48.3	57.1 percentage of participants Interval 51.1 to 63.2
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period Week 52	11.7 percentage of participants Interval 7.9 to 15.6	36.8 percentage of participants Interval 30.9 to 42.7	54.1 percentage of participants Interval 48.0 to 60.2

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\] and lichenification \[L\]) was scored separately for each of 4 body regions (head and neck \[h\], upper limbs \[u\], trunk \[t\] \[including axillae and groin\] and lower limbs \[l\] \[including buttocks\]) on 4-point scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score = 0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); where A = area score. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=267 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=264 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=266 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 12	100.0 percentage of participants Interval 98.6 to 100.0	100.0 percentage of participants Interval 98.6 to 100.0	100.0 percentage of participants Interval 98.6 to 100.0
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 16	40.8 percentage of participants Interval 34.9 to 46.7	83.3 percentage of participants Interval 78.8 to 87.8	96.2 percentage of participants Interval 94.0 to 98.5
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 28	22.8 percentage of participants Interval 17.8 to 27.9	68.1 percentage of participants Interval 62.4 to 73.7	85.9 percentage of participants Interval 81.7 to 90.1
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 40	16.6 percentage of participants Interval 12.1 to 21.1	57.3 percentage of participants Interval 51.3 to 63.3	74.9 percentage of participants Interval 69.6 to 80.2
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 52	15.9 percentage of participants Interval 11.5 to 20.3	50.8 percentage of participants Interval 44.7 to 56.9	71.2 percentage of participants Interval 65.7 to 76.7

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score = 0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll). Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=267 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=264 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=266 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 12	99.2 percentage of participants Interval 98.2 to 100.0	100.0 percentage of participants Interval 98.6 to 100.0	99.6 percentage of participants Interval 98.9 to 100.0
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 16	27.0 percentage of participants Interval 21.6 to 32.3	76.0 percentage of participants Interval 70.9 to 81.2	92.5 percentage of participants Interval 89.3 to 95.7
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 28	18.0 percentage of participants Interval 13.4 to 22.6	60.4 percentage of participants Interval 54.4 to 66.3	80.5 percentage of participants Interval 75.7 to 85.3
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 40	15.1 percentage of participants Interval 10.8 to 19.4	54.2 percentage of participants Interval 48.2 to 60.3	71.8 percentage of participants Interval 66.3 to 77.3
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 52	14.0 percentage of participants Interval 9.8 to 18.2	46.5 percentage of participants Interval 40.4 to 52.6	65.8 percentage of participants Interval 60.0 to 71.6

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score = 0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=267 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=264 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=266 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 12	84.6 percentage of participants Interval 80.2 to 88.9	87.1 percentage of participants Interval 83.1 to 91.2	86.4 percentage of participants Interval 82.3 to 90.5
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 16	13.9 percentage of participants Interval 9.7 to 18.0	51.3 percentage of participants Interval 45.3 to 57.4	77.1 percentage of participants Interval 72.0 to 82.1
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 28	10.5 percentage of participants Interval 6.8 to 14.2	46.9 percentage of participants Interval 40.9 to 53.0	64.5 percentage of participants Interval 58.7 to 70.3
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 40	12.1 percentage of participants Interval 8.2 to 16.0	41.5 percentage of participants Interval 35.5 to 47.5	58.7 percentage of participants Interval 52.7 to 64.7
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 52	10.6 percentage of participants Interval 6.9 to 14.3	37.6 percentage of participants Interval 31.7 to 43.5	54.5 percentage of participants Interval 48.4 to 60.6

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=267 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=264 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=266 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 52	4.5 percentage of participants Interval 2.0 to 7.1	18.6 percentage of participants Interval 13.9 to 23.4	28.8 percentage of participants Interval 23.3 to 34.3
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 12	30.5 percentage of participants Interval 24.9 to 36.0	30.3 percentage of participants Interval 24.8 to 35.8	28.3 percentage of participants Interval 22.9 to 33.7
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 16	3.7 percentage of participants Interval 1.5 to 6.0	15.2 percentage of participants Interval 10.9 to 19.5	28.9 percentage of participants Interval 23.5 to 34.4
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 28	4.1 percentage of participants Interval 1.7 to 6.5	16.5 percentage of participants Interval 12.0 to 21.1	30.2 percentage of participants Interval 24.6 to 35.7
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 40	4.5 percentage of participants Interval 2.0 to 7.0	15.8 percentage of participants Interval 11.3 to 20.2	30.1 percentage of participants Interval 24.5 to 35.7

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated worse disease status.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=258 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=254 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=250 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 12	82.2 percentage of participants Interval 77.2 to 87.1	84.0 percentage of participants Interval 79.3 to 88.6	81.9 percentage of participants Interval 76.9 to 86.9
Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 16	15.9 percentage of participants Interval 11.4 to 20.4	54.6 percentage of participants Interval 48.4 to 60.7	75.6 percentage of participants Interval 70.3 to 80.9
Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 28	11.6 percentage of participants Interval 7.7 to 15.5	45.0 percentage of participants Interval 38.9 to 51.2	66.9 percentage of participants Interval 61.0 to 72.8
Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 40	10.1 percentage of participants Interval 6.4 to 13.8	39.4 percentage of participants Interval 33.4 to 45.4	55.7 percentage of participants Interval 49.5 to 61.9
Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 52	8.3 percentage of participants Interval 4.9 to 11.7	27.6 percentage of participants Interval 21.7 to 33.6	49.0 percentage of participants Interval 42.2 to 55.9

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

4 body regions evaluated: head and neck, upper limbs, trunk (including axillae, groin/genitals), lower limbs (including buttocks) excluding scalp, palms, soles. BSA calculated by handprint method. Number (No) of handprints (size of participant's hand with fingers in closed position) fitting in affected area of a body region was estimated. Maximum No of handprints were 10, 20, 30, 40 for head and neck, upper limbs, trunk, and lower limbs respectively. Surface area (SA) of body region equivalent to 1 handprint: 1 handprint=10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. %Change BSA for a body region was calculated as=total No of handprints in a body region\* %SA equivalent to 1 handprint. %BSA for an individual: arithmetic mean of %BSA of all 4 body regions, ranged from 0-100%, higher values=greater AD severity.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=266 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=264 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=265 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 12	-95.6 percent change Interval -100.0 to -88.5	-96.7 percent change Interval -100.0 to -91.5	-96.7 percent change Interval -100.0 to -89.2
Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 16	-68.5 percent change Interval -89.8 to -37.5	-90.9 percent change Interval -97.6 to -78.3	-96.3 percent change Interval -100.0 to -88.7
Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 28	-85.2 percent change Interval -95.8 to -63.5	-93.8 percent change Interval -99.5 to -81.4	-96.4 percent change Interval -100.0 to -85.7
Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 40	-91.2 percent change Interval -100.0 to -77.9	-95.8 percent change Interval -100.0 to -83.5	-96.8 percent change Interval -100.0 to -88.8
Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 52	-91.5 percent change Interval -100.0 to -77.9	-96.9 percent change Interval -100.0 to -83.4	-96.9 percent change Interval -100.0 to -88.2

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3); severity scores added to give B (0-18). C: pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\*B/2+C; range (0-103); higher values=worse outcome.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=265 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=264 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=265 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 12	-84.0 percent change Interval -94.7 to -73.5	-84.4 percent change Interval -95.2 to -74.9	-84.4 percent change Interval -93.8 to -74.2
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 16	-50.4 percent change Interval -68.3 to -32.1	-71.7 percent change Interval -87.8 to -60.5	-83.6 percent change Interval -95.1 to -70.6
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 28	-63.4 percent change Interval -81.9 to -48.3	-77.8 percent change Interval -90.2 to -62.6	-83.8 percent change Interval -97.4 to -66.4
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 40	-74.4 percent change Interval -89.5 to -60.6	-77.1 percent change Interval -94.1 to -64.3	-84.6 percent change Interval -98.6 to -68.4
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 52	-73.3 percent change Interval -89.8 to -58.0	-82.5 percent change Interval -97.7 to -64.1	-83.2 percent change Interval -100.0 to -69.1

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region-head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\*B/2+C; range (0-103); higher values=worse outcome.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=264 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=264 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=261 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period Sleep Loss VAS: Change at Week 28	1.3 units on a scale Interval 0.9 to 1.7	0.6 units on a scale Interval 0.4 to 0.9	0.2 units on a scale Interval 0.0 to 0.4
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period Sleep Loss VAS: Change at Week 40	1.3 units on a scale Interval 0.8 to 1.8	0.6 units on a scale Interval 0.3 to 0.9	0.2 units on a scale Interval 0.0 to 0.4
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period Pruritus VAS: Change at Week 12	-6.1 units on a scale Interval -6.3 to -5.9	-6.1 units on a scale Interval -6.3 to -5.9	-6.1 units on a scale Interval -6.3 to -5.9
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period Pruritus VAS: Change at Week 16	3.4 units on a scale Interval 3.0 to 3.7	1.2 units on a scale Interval 1.0 to 1.5	0.2 units on a scale Interval -0.1 to 0.4
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period Pruritus VAS: Change at Week 28	2.4 units on a scale Interval 1.9 to 2.9	1.1 units on a scale Interval 0.8 to 1.4	0.5 units on a scale Interval 0.3 to 0.8
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period Pruritus VAS: Change at Week 40	2.2 units on a scale Interval 1.6 to 2.8	1.2 units on a scale Interval 0.9 to 1.6	0.4 units on a scale Interval 0.1 to 0.7
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period Pruritus VAS: Change at Week 52	1.8 units on a scale Interval 1.2 to 2.4	1.3 units on a scale Interval 0.9 to 1.6	0.5 units on a scale Interval 0.2 to 0.8
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period Sleep Loss VAS: Change at Week 12	-5.0 units on a scale Interval -5.2 to -4.8	-5.0 units on a scale Interval -5.2 to -4.8	-5.1 units on a scale Interval -5.3 to -4.9
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period Sleep Loss VAS: Change at Week 16	2.3 units on a scale Interval 2.0 to 2.6	0.5 units on a scale Interval 0.3 to 0.8	0.0 units on a scale Interval -0.2 to 0.2
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period Sleep Loss VAS: Change at Week 52	1.2 units on a scale Interval 0.7 to 1.8	0.9 units on a scale Interval 0.5 to 1.2	0.3 units on a scale Interval 0.0 to 0.5

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\*B/2+C; range (0-103); higher values=worse outcome.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=266 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=264 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=266 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 12	97.4 percentage of participants Interval 95.4 to 99.3	98.5 percentage of participants Interval 97.0 to 100.0	97.0 percentage of participants Interval 94.9 to 99.0
Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 16	25.6 percentage of participants Interval 20.3 to 30.8	72.0 percentage of participants Interval 66.6 to 77.4	89.1 percentage of participants Interval 85.4 to 92.8
Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 28	15.8 percentage of participants Interval 11.4 to 20.2	56.8 percentage of participants Interval 50.7 to 62.8	75.7 percentage of participants Interval 70.5 to 80.9
Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 40	14.4 percentage of participants Interval 10.2 to 18.6	51.2 percentage of participants Interval 45.1 to 57.2	69.0 percentage of participants Interval 63.3 to 74.6
Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 52	14.8 percentage of participants Interval 10.5 to 19.1	44.6 percentage of participants Interval 38.5 to 50.6	65.8 percentage of participants Interval 60.0 to 71.6

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\*B/2+C; range (0-103); higher values=worse outcome.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=266 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=264 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=266 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 12	73.6 percentage of participants Interval 68.3 to 78.9	75.0 percentage of participants Interval 69.8 to 80.2	71.3 percentage of participants Interval 65.9 to 76.8
Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 16	9.4 percentage of participants Interval 5.9 to 12.9	38.3 percentage of participants Interval 32.4 to 44.1	67.3 percentage of participants Interval 61.7 to 72.9
Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 28	7.5 percentage of participants Interval 4.3 to 10.7	37.8 percentage of participants Interval 31.9 to 43.7	56.3 percentage of participants Interval 50.3 to 62.3
Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 40	8.3 percentage of participants Interval 5.0 to 11.7	32.7 percentage of participants Interval 27.0 to 38.4	47.7 percentage of participants Interval 41.6 to 53.8
Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 52	7.6 percentage of participants Interval 4.4 to 10.8	31.8 percentage of participants Interval 26.1 to 37.5	45.9 percentage of participants Interval 39.8 to 52.0

SECONDARY outcome

Timeframe: Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12

Population: Full analysis set-rescue (FAS-RE) included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified time points.

IGA assessed severity of AD on a 5-point scale (0-4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0=clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=342 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period Rescue Week 2	30.7 percentage of participants Interval 25.8 to 35.7	—	—
Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period Rescue Week 4	54.6 percentage of participants Interval 49.3 to 59.9	—	—
Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period Rescue Week 8	60.2 percentage of participants Interval 55.0 to 65.4	—	—
Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period Rescue Week 12	64.1 percentage of participants Interval 59.0 to 69.2	—	—

SECONDARY outcome

Timeframe: Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12

Population: FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=348 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period Change at Rescue Week 2	-71.1 percent change 95% Confidence Interval -73.7 • Interval -73.7 to -68.5	—	—
Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period Change at Rescue Week 4	-82.0 percent change 95% Confidence Interval -84.2 • Interval -84.2 to -79.7	—	—
Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period Change at Rescue Week 8	-86.4 percent change 95% Confidence Interval -88.2 • Interval -88.2 to -84.6	—	—
Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period Change at Rescue Week 12	-87.3 percent change 95% Confidence Interval -89.4 • Interval -89.4 to -85.3	—	—

SECONDARY outcome

Timeframe: Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=272 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Percentage of Participants Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period Rescue Week 2	56.6 percentage of participants Interval 50.7 to 62.5	—	—
Percentage of Participants Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period Rescue Week 4	63.2 percentage of participants Interval 57.2 to 69.2	—	—
Percentage of Participants Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period Rescue Week 8	67.2 percentage of participants Interval 61.4 to 73.0	—	—
Percentage of Participants Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period Rescue Week 12	56.2 percentage of participants Interval 48.3 to 64.1	—	—

SECONDARY outcome

Timeframe: Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12

4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin/genitals) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Overall % BSA for an individual % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=348 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period Change at Rescue Week 2	-62.8 percent change Interval -66.0 to -59.6	—	—
Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period Change at Rescue Week 4	-76.4 percent change Interval -79.1 to -73.7	—	—
Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period Change at Rescue Week 8	-82.1 percent change Interval -84.5 to -79.6	—	—
Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period Change at Rescue Week 12	-83.3 percent change Interval -86.0 to -80.5	—	—

SECONDARY outcome

Timeframe: Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12

Population: FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment.. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\*B/2+C; range (0-103); higher values=worse outcome.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=347 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period Pruritus VAS: Change at Rescue Week 2	-57.3 percent change 95% Confidence Interval -61.7 • Interval -61.7 to -52.9	—	—
Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period Pruritus VAS: Change at Rescue Week 4	-67.5 percent change 95% Confidence Interval -71.3 • Interval -71.3 to -63.7	—	—
Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period Pruritus VAS: Change at Rescue Week 8	-68.6 percent change 95% Confidence Interval -73.6 • Interval -73.6 to -63.7	—	—
Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period Pruritus VAS: Change at Rescue Week 12	-67.3 percent change 95% Confidence Interval -72.8 • Interval -72.8 to -61.8	—	—
Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period Sleep Loss VAS: Change at Rescue Week 2	-62.5 percent change 95% Confidence Interval -69.1 • Interval -69.1 to -55.9	—	—
Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period Sleep Loss VAS: Change at Rescue Week 4	-72.4 percent change 95% Confidence Interval -78.6 • Interval -78.6 to -66.3	—	—
Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period Sleep Loss VAS: Change at Rescue Week 8	-75.8 percent change 95% Confidence Interval -82.0 • Interval -82.0 to -69.5	—	—
Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period Sleep Loss VAS: Change at Rescue Week 12	-74.5 percent change 95% Confidence Interval -81.4 • Interval -81.4 to -67.5	—	—

SECONDARY outcome

Timeframe: Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12

SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\*B/2+C; range (0-103); higher values=worse outcome.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=339 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period Rescue Week 2	55.0 percentage of participants Interval 49.6 to 60.3	—	—
Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period Rescue Week 4	76.1 percentage of participants Interval 71.6 to 80.6	—	—
Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period Rescue Week 8	79.6 percentage of participants Interval 75.3 to 83.9	—	—
Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period Rescue Week 12	79.8 percentage of participants Interval 75.5 to 84.1	—	—

SECONDARY outcome

Timeframe: Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12

SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\*B/2+C; range (0-103); higher values=worse outcome.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=339 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period Rescue Week 2	16.9 percentage of participants Interval 12.9 to 21.0	—	—
Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period Rescue Week 4	33.9 percentage of participants Interval 28.9 to 39.0	—	—
Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period Rescue Week 8	44.4 percentage of participants Interval 39.1 to 49.7	—	—
Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period Rescue Week 12	45.4 percentage of participants Interval 40.1 to 50.7	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

Participant responded to the following question: "Overall, how would you describe your Atopic Dermatitis right now?" on a 5-point scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=254 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=262 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=259 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 52	7.6 percentage of participants Interval 4.3 to 10.8	25.8 percentage of participants Interval 20.4 to 31.1	39.7 percentage of participants Interval 33.6 to 45.8
Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 12	61.7 percentage of participants Interval 55.7 to 67.7	64.5 percentage of participants Interval 58.7 to 70.3	59.7 percentage of participants Interval 53.7 to 65.7
Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 16	5.9 percentage of participants Interval 3.0 to 8.8	29.8 percentage of participants Interval 24.2 to 35.3	48.3 percentage of participants Interval 42.2 to 54.3
Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 28	6.3 percentage of participants Interval 3.3 to 9.3	30.9 percentage of participants Interval 25.3 to 36.5	46.9 percentage of participants Interval 40.8 to 53.0
Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Week 40	7.5 percentage of participants Interval 4.3 to 10.8	26.1 percentage of participants Interval 20.7 to 31.4	42.0 percentage of participants Interval 35.9 to 48.1

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for adults, aged 18 years and above.

DLQI was a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=217 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=215 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=217 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 12	-13.5 units on a scale 95% Confidence Interval -13.9 • Interval -13.9 to -13.0	-13.4 units on a scale 95% Confidence Interval -13.8 • Interval -13.8 to -12.9	-13.5 units on a scale 95% Confidence Interval -14.0 • Interval -14.0 to -13.1
Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 16	6.9 units on a scale 95% Confidence Interval 6.1 • Interval 6.1 to 7.8	1.9 units on a scale 95% Confidence Interval 1.2 • Interval 1.2 to 2.5	0.4 units on a scale 95% Confidence Interval -0.2 • Interval -0.2 to 1.0
Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 28	6.1 units on a scale 95% Confidence Interval 5.0 • Interval 5.0 to 7.1	2.1 units on a scale 95% Confidence Interval 1.4 • Interval 1.4 to 2.7	0.9 units on a scale 95% Confidence Interval 0.3 • Interval 0.3 to 1.5
Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 40	4.4 units on a scale 95% Confidence Interval 3.0 • Interval 3.0 to 5.7	2.5 units on a scale 95% Confidence Interval 1.7 • Interval 1.7 to 3.2	1.1 units on a scale 95% Confidence Interval 0.5 • Interval 0.5 to 1.8
Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 52	3.6 units on a scale 95% Confidence Interval 2.1 • Interval 2.1 to 5.0	2.8 units on a scale 95% Confidence Interval 2.0 • Interval 2.0 to 3.6	0.9 units on a scale 95% Confidence Interval 0.2 • Interval 0.2 to 1.6

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 28, 40 and 52

CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all , 1 = only a little, 2 = quite a lot, 3 = very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give CDLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=49 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=48 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=47 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 12	-9.8 units on a scale 95% Confidence Interval -10.6 • Interval -10.6 to -8.9	-9.2 units on a scale 95% Confidence Interval -10.0 • Interval -10.0 to -8.3	-9.3 units on a scale 95% Confidence Interval -10.2 • Interval -10.2 to -8.5
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 16	5.9 units on a scale 95% Confidence Interval 4.4 • Interval 4.4 to 7.5	1.7 units on a scale 95% Confidence Interval 0.5 • Interval 0.5 to 2.9	-0.3 units on a scale 95% Confidence Interval -1.4 • Interval -1.4 to 0.8
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 28	1.5 units on a scale 95% Confidence Interval -0.2 • Interval -0.2 to 3.2	1.6 units on a scale 95% Confidence Interval 0.6 • Interval 0.6 to 2.6	0.4 units on a scale 95% Confidence Interval -0.5 • Interval -0.5 to 1.3
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 40	2.1 units on a scale 95% Confidence Interval 0.3 • Interval 0.3 to 3.8	1.7 units on a scale 95% Confidence Interval 0.7 • Interval 0.7 to 2.7	0.0 units on a scale 95% Confidence Interval -0.9 • Interval -0.9 to 0.9
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 52	2.3 units on a scale 95% Confidence Interval 0.3 • Interval 0.3 to 4.4	1.3 units on a scale 95% Confidence Interval 0.0 • Interval 0.0 to 2.6	0.4 units on a scale 95% Confidence Interval -0.6 • Interval -0.6 to 1.4

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=266 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=263 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=264 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 12	-2.7 units on a scale 95% Confidence Interval -3.0 • Interval -3.0 to -2.3	-2.6 units on a scale 95% Confidence Interval -2.9 • Interval -2.9 to -2.3	-2.6 units on a scale 95% Confidence Interval -2.9 • Interval -2.9 to -2.3
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 16	1.4 units on a scale 95% Confidence Interval 1.0 • Interval 1.0 to 1.8	0.3 units on a scale 95% Confidence Interval 0.0 • Interval 0.0 to 0.6	0.0 units on a scale 95% Confidence Interval -0.3 • Interval -0.3 to 0.3
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 28	1.0 units on a scale 95% Confidence Interval 0.5 • Interval 0.5 to 1.5	0.4 units on a scale 95% Confidence Interval 0.1 • Interval 0.1 to 0.7	0.1 units on a scale 95% Confidence Interval -0.2 • Interval -0.2 to 0.4
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 40	1.0 units on a scale 95% Confidence Interval 0.4 • Interval 0.4 to 1.6	0.4 units on a scale 95% Confidence Interval 0.1 • Interval 0.1 to 0.8	0.1 units on a scale 95% Confidence Interval -0.3 • Interval -0.3 to 0.4
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 52	0.8 units on a scale 95% Confidence Interval 0.2 • Interval 0.2 to 1.4	0.4 units on a scale 95% Confidence Interval 0.1 • Interval 0.1 to 0.8	0.2 units on a scale 95% Confidence Interval -0.1 • Interval -0.1 to 0.5

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=266 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=263 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=264 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 12	-2.0 units on a scale 95% Confidence Interval -2.3 • Interval -2.3 to -1.7	-1.6 units on a scale 95% Confidence Interval -1.9 • Interval -1.9 to -1.3	-1.7 units on a scale 95% Confidence Interval -2.0 • Interval -2.0 to -1.4
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 16	1.4 units on a scale 95% Confidence Interval 1.0 • Interval 1.0 to 1.8	0.0 units on a scale 95% Confidence Interval -0.3 • Interval -0.3 to 0.3	0.0 units on a scale 95% Confidence Interval -0.2 • Interval -0.2 to 0.3
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 28	0.7 units on a scale 95% Confidence Interval 0.2 • Interval 0.2 to 1.1	0.3 units on a scale 95% Confidence Interval 0.0 • Interval 0.0 to 0.5	0.1 units on a scale 95% Confidence Interval -0.2 • Interval -0.2 to 0.4
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 40	0.8 units on a scale 95% Confidence Interval 0.2 • Interval 0.2 to 1.4	-0.1 units on a scale 95% Confidence Interval -0.4 • Interval -0.4 to 0.3	0.2 units on a scale 95% Confidence Interval -0.1 • Interval -0.1 to 0.5
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 52	0.4 units on a scale 95% Confidence Interval -0.1 • Interval -0.1 to 0.9	-0.1 units on a scale 95% Confidence Interval -0.4 • Interval -0.4 to 0.2	0.1 units on a scale 95% Confidence Interval -0.2 • Interval -0.2 to 0.3

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

POEM was a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item scored as following: no days = 0, 1-2 days = 1, 3-4 days = 2, 5-6 days = 3 and, every day = 4. The total POEM score ranges from 0 to 28, where higher score indicated greater severity.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=265 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=263 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=263 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 28	8.3 units on a scale 95% Confidence Interval 6.9 • Interval 6.9 to 9.7	3.7 units on a scale 95% Confidence Interval 2.8 • Interval 2.8 to 4.6	1.6 units on a scale 95% Confidence Interval 0.8 • Interval 0.8 to 2.4
Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 12	-15.4 units on a scale 95% Confidence Interval -16.0 • Interval -16.0 to -14.8	-15.8 units on a scale 95% Confidence Interval -16.4 • Interval -16.4 to -15.2	-15.4 units on a scale 95% Confidence Interval -16.0 • Interval -16.0 to -14.8
Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 16	9.8 units on a scale 95% Confidence Interval 8.9 • Interval 8.9 to 10.7	3.7 units on a scale 95% Confidence Interval 3.0 • Interval 3.0 to 4.4	0.6 units on a scale 95% Confidence Interval -0.1 • Interval -0.1 to 1.2
Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 40	7.4 units on a scale 95% Confidence Interval 5.8 • Interval 5.8 to 9.1	4.8 units on a scale 95% Confidence Interval 3.9 • Interval 3.9 to 5.8	1.9 units on a scale 95% Confidence Interval 1.1 • Interval 1.1 to 2.8
Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 52	7.3 units on a scale 95% Confidence Interval 5.4 • Interval 5.4 to 9.2	4.9 units on a scale 95% Confidence Interval 3.8 • Interval 3.8 to 6.0	2.2 units on a scale 95% Confidence Interval 1.3 • Interval 1.3 to 3.2

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \[darker or lighter\], bleeding from skin, seeping or oozing fluid from skin \[other than blood\], and skin swelling). Participants had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.

Outcome measures

Outcome measures
Measure	PF-04965842 200 mg OL to Placebo DB n=254 Participants Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=260 Participants Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=254 Participants Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 12	-4.1 units on a scale 95% Confidence Interval -4.3 • Interval -4.3 to -3.9	-4.2 units on a scale 95% Confidence Interval -4.4 • Interval -4.4 to -4.0	-4.2 units on a scale 95% Confidence Interval -4.4 • Interval -4.4 to -4.0
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 16	2.1 units on a scale 95% Confidence Interval 1.9 • Interval 1.9 to 2.2	0.8 units on a scale 95% Confidence Interval 0.6 • Interval 0.6 to 0.9	0.1 units on a scale 95% Confidence Interval -0.1 • Interval -0.1 to 0.3
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 28	2.3 units on a scale 95% Confidence Interval 2.0 • Interval 2.0 to 2.6	1.0 units on a scale 95% Confidence Interval 0.8 • Interval 0.8 to 1.2	0.1 units on a scale 95% Confidence Interval -0.1 • Interval -0.1 to 0.3
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 40	2.0 units on a scale 95% Confidence Interval 1.7 • Interval 1.7 to 2.4	1.0 units on a scale 95% Confidence Interval 0.8 • Interval 0.8 to 1.3	0.3 units on a scale 95% Confidence Interval 0.0 • Interval 0.0 to 0.5
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period Change at Week 52	1.9 units on a scale 95% Confidence Interval 1.5 • Interval 1.5 to 2.3	1.2 units on a scale 95% Confidence Interval 0.9 • Interval 0.9 to 1.4	0.2 units on a scale 95% Confidence Interval 0.0 • Interval 0.0 to 0.5

Adverse Events

PF-04965842 200 mg OL

Serious events: 20 serious events

Other events: 482 other events

Deaths: 1 deaths

PF-04965842 200 mg OL to Placebo DB

Serious events: 3 serious events

Other events: 158 other events

Deaths: 0 deaths

PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB

Serious events: 9 serious events

Other events: 130 other events

Deaths: 0 deaths

PF-04965842 200 mg OL to PF-04965842 200 mg DB

Serious events: 14 serious events

Other events: 152 other events

Deaths: 0 deaths

PF-04965842 200 mg Rescue Period

Serious events: 4 serious events

Other events: 75 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PF-04965842 200 mg OL n=1233 participants at risk Participants received 12 weeks induction treatment of 200 mg oral tablets (each tablet of 100 mg) PF-04965842 QD during an OL run-in period. Responders at the end of the 12-week open-label run-in period entered the 40 weeks, DB, maintenance treatment period. Responder criteria was defined as a) achieving an IGA of clear (0) or almost clear (1) (on a 5-point scale), b) a reduction from IGA baseline of \>= 2 points, and c) reaching an EASI-75 response compared to baseline score. Baseline score was the IGA score and EASI score obtained prior to dosing on Day 1. Non-responders had a choice to enroll into the PF-04965842 LTE study B7451015 (NCT03422822) otherwise, they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to Placebo DB n=267 participants at risk Responders from open-label run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=265 participants at risk Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=266 participants at risk Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg Rescue Period n=351 participants at risk Participants who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during open-label Rescue Period for up to 12 weeks. After completing the 12-week rescue period, participants had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Participants who discontinued early from treatment, or who were otherwise ineligible for the LTE study, were followed-up for 4 week in this study.
Congenital, familial and genetic disorders Vitello-intestinal duct remnant	0.00% 0/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Microcytic anaemia	0.08% 1/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Thrombocytopenia	0.08% 1/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Nervous system disorders Seizure	0.00% 0/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Eye disorders Cataract	0.08% 1/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Eye disorders Retinal detachment	0.08% 1/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Eye disorders Retinal vein thrombosis	0.00% 0/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Eye disorders Ulcerative keratitis	0.08% 1/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Inguinal hernia	0.00% 0/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Renal and urinary disorders Ureterolithiasis	0.08% 1/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.37% 1/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.28% 1/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.24% 3/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.57% 2/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.08% 1/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Myositis	0.08% 1/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypokalaemia	0.08% 1/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Abscess neck	0.00% 0/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Appendicitis	0.08% 1/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Cellulitis	0.16% 2/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Diverticulitis	0.00% 0/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Eczema herpeticum	0.00% 0/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Gastrointestinal viral infection	0.00% 0/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.37% 1/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Hepatitis E	0.00% 0/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Periodontitis	0.08% 1/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Peritonsillar abscess	0.00% 0/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Pharyngitis	0.08% 1/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.28% 1/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Pneumonia	0.08% 1/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.37% 1/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Skin infection	0.08% 1/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Ligament injury	0.08% 1/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Meniscus injury	0.08% 1/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.08% 1/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
General disorders Chest pain	0.08% 1/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Immune system disorders Anaphylactic reaction	0.00% 0/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Reproductive system and breast disorders Adnexa uteri cyst	0.00% 0/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.38% 1/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Reproductive system and breast disorders Metrorrhagia	0.08% 1/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	0.00% 0/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.

Other adverse events

Other adverse events
Measure	PF-04965842 200 mg OL n=1233 participants at risk Participants received 12 weeks induction treatment of 200 mg oral tablets (each tablet of 100 mg) PF-04965842 QD during an OL run-in period. Responders at the end of the 12-week open-label run-in period entered the 40 weeks, DB, maintenance treatment period. Responder criteria was defined as a) achieving an IGA of clear (0) or almost clear (1) (on a 5-point scale), b) a reduction from IGA baseline of \>= 2 points, and c) reaching an EASI-75 response compared to baseline score. Baseline score was the IGA score and EASI score obtained prior to dosing on Day 1. Non-responders had a choice to enroll into the PF-04965842 LTE study B7451015 (NCT03422822) otherwise, they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to Placebo DB n=267 participants at risk Responders from open-label run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB n=265 participants at risk Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg OL to PF-04965842 200 mg DB n=266 participants at risk Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	PF-04965842 200 mg Rescue Period n=351 participants at risk Participants who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during open-label Rescue Period for up to 12 weeks. After completing the 12-week rescue period, participants had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Participants who discontinued early from treatment, or who were otherwise ineligible for the LTE study, were followed-up for 4 week in this study.
Investigations Blood creatine phosphokinase increased	3.5% 43/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	4.1% 11/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	6.8% 18/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	9.4% 25/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	2.6% 9/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Nervous system disorders Headache	9.7% 119/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	11.6% 31/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	9.1% 24/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	11.7% 31/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	3.4% 12/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Nausea	16.1% 199/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	16.5% 44/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	13.2% 35/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	18.4% 49/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	3.4% 12/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Acne	5.5% 68/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	7.1% 19/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	8.3% 22/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	11.7% 31/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	2.0% 7/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Dermatitis atopic	3.6% 45/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	33.0% 88/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	21.1% 56/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	13.5% 36/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	3.7% 13/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Nasopharyngitis	6.2% 77/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	9.7% 26/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	10.2% 27/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	10.5% 28/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	4.8% 17/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Infections and infestations Upper respiratory tract infection	5.1% 63/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	9.7% 26/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	8.3% 22/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	8.3% 22/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	6.0% 21/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	3.4% 42/1233 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	2.6% 7/267 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	4.5% 12/265 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	5.6% 15/266 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.	1.1% 4/351 • From screening up to 28 days after last dose of study treatment (maximum up to Week 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.

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