Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo (NCT NCT04818346)

Last Updated: 2024-04-11

Results Overview

The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area \[BSA\]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites. Percent change was calculated as (\[post-Baseline value minus the Baseline value\] / Baseline value) x 100.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

171 participants

Primary outcome timeframe

Baseline; Week 24

Results posted on

2024-04-11

Participant Flow

This study was conducted in 28 sites in Canada and the United States.

Participant milestones

Participant milestones
Measure	Povorcitinib 75 mg Participants received oral povorcitinib 75 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period.	Placebo Participants received matching placebo QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period).	Povorcitinib 15 mg Participants received oral povorcitinib 15 milligrams (mg) once daily (QD) for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for 28 weeks (double-blind extension period).	Povorcitinib 45 mg Participants received oral povorcitinib 45 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 45 mg QD for an additional 28 weeks (double-blind extension period).
24-Week Placebo-controlled Period STARTED	42	43	43	43
24-Week Placebo-controlled Period COMPLETED	34	35	38	32
24-Week Placebo-controlled Period NOT COMPLETED	8	8	5	11
28-Week Double-blind Extension Period STARTED	34	35	37	32
28-Week Double-blind Extension Period COMPLETED	28	33	30	26
28-Week Double-blind Extension Period NOT COMPLETED	6	2	7	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Povorcitinib 75 mg Participants received oral povorcitinib 75 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period.	Placebo Participants received matching placebo QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period).	Povorcitinib 15 mg Participants received oral povorcitinib 15 milligrams (mg) once daily (QD) for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for 28 weeks (double-blind extension period).	Povorcitinib 45 mg Participants received oral povorcitinib 45 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 45 mg QD for an additional 28 weeks (double-blind extension period).
24-Week Placebo-controlled Period Adverse Event	3	1	2	0
24-Week Placebo-controlled Period Lost to Follow-up	1	3	2	3
24-Week Placebo-controlled Period Physician Decision	0	1	0	0
24-Week Placebo-controlled Period Protocol Violation	1	0	0	1
24-Week Placebo-controlled Period Withdrawal by Subject	2	1	1	6
24-Week Placebo-controlled Period Subject Terminated by Sponsor	0	1	0	0
24-Week Placebo-controlled Period Latent Tuberculosis; Unable to Provide Proof of Treatment	0	1	0	0
24-Week Placebo-controlled Period Use of Prohibited Concomitant Medication	0	0	0	1
24-Week Placebo-controlled Period Ineligible to Be Included in the Study Due to Abnormal Coagulation Profile	1	0	0	0
28-Week Double-blind Extension Period Adverse Event	1	1	0	1
28-Week Double-blind Extension Period Lost to Follow-up	1	1	2	1
28-Week Double-blind Extension Period Withdrawal by Subject	3	0	3	4
28-Week Double-blind Extension Period Non-compliance	0	0	1	0
28-Week Double-blind Extension Period Non-compliance with Study Drug	0	0	1	0
28-Week Double-blind Extension Period Scheduling Conflicts	1	0	0	0

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=43 Participants Participants received matching placebo QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period).	Povorcitinib 15 mg n=43 Participants Participants received oral povorcitinib 15 milligrams (mg) once daily (QD) for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for 28 weeks (double-blind extension period).	Povorcitinib 45 mg n=43 Participants Participants received oral povorcitinib 45 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 45 mg QD for an additional 28 weeks (double-blind extension period).	Povorcitinib 75 mg n=42 Participants Participants received oral povorcitinib 75 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period.	Total n=171 Participants Total of all reporting groups
Age, Continuous	48.6 years STANDARD_DEVIATION 12.92 • n=5 Participants	45.9 years STANDARD_DEVIATION 11.56 • n=7 Participants	50.2 years STANDARD_DEVIATION 11.61 • n=5 Participants	50.5 years STANDARD_DEVIATION 11.69 • n=4 Participants	48.8 years STANDARD_DEVIATION 11.99 • n=21 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	29 Participants n=7 Participants	21 Participants n=5 Participants	19 Participants n=4 Participants	93 Participants n=21 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	14 Participants n=7 Participants	22 Participants n=5 Participants	23 Participants n=4 Participants	78 Participants n=21 Participants
Race/Ethnicity, Customized White/Caucasian	34 Participants n=5 Participants	32 Participants n=7 Participants	38 Participants n=5 Participants	28 Participants n=4 Participants	132 Participants n=21 Participants
Race/Ethnicity, Customized Black/African-American	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	9 Participants n=21 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants	13 Participants n=21 Participants
Race/Ethnicity, Customized Mexican American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized African-European	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Middle Eastern	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Columbian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Captured as Hispanic in Database	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Mixed	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Mexican	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized East Indian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Did Not Identify with Options Provided	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White and Asian-Non-Japanese	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized South African	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White/Black	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized South American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Egyptian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Captured as Hispanic/Latino in Database	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	8 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants	7 Participants n=4 Participants	32 Participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	35 Participants n=5 Participants	36 Participants n=7 Participants	32 Participants n=5 Participants	34 Participants n=4 Participants	137 Participants n=21 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Bangladeshi	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Total Vitiligo Area Scoring Index (T-VASI)	28.31 scores on a scale STANDARD_DEVIATION 21.481 • n=5 Participants	27.13 scores on a scale STANDARD_DEVIATION 20.085 • n=7 Participants	23.64 scores on a scale STANDARD_DEVIATION 19.758 • n=5 Participants	22.65 scores on a scale STANDARD_DEVIATION 14.244 • n=4 Participants	25.45 scores on a scale STANDARD_DEVIATION 19.094 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline; Week 24

Population: Intent-to-Treat Population: all randomized participants. Treatment groups for this population were defined according to the treatment assignment at randomization. Mixed-effect model for repeated measures (MMRM) model: (percent change from Baseline = treatment + stratification factor \[T-BSA involvement 8%-20%/\>20%\] + visit + treatment\*visit + Baseline measurement + Baseline measurement\*visit). Only participants with available data were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=33 Participants Participants received matching placebo QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period).	Povorcitinib 15 mg n=38 Participants Participants received oral povorcitinib 15 milligrams (mg) once daily (QD) for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for 28 weeks (double-blind extension period).	Povorcitinib 45 mg n=33 Participants Participants received oral povorcitinib 45 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 45 mg QD for an additional 28 weeks (double-blind extension period).	Povorcitinib 75 mg n=36 Participants Participants received oral povorcitinib 75 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period).
Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24	2.29 percent change Standard Error 4.81	-19.12 percent change Standard Error 4.56	-17.78 percent change Standard Error 4.87	-15.73 percent change Standard Error 4.74

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: Intent-to-Treat Population. The 95% confidence interval was based on the Clopper-Pearson exact method. Only participants with available data were analyzed.

T-VASI50 was defined as a 50% or greater reduction from Baseline in T-VASI. The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive body regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area \[BSA\]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites.

Outcome measures

Outcome measures
Measure	Placebo n=43 Participants Participants received matching placebo QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period).	Povorcitinib 15 mg n=43 Participants Participants received oral povorcitinib 15 milligrams (mg) once daily (QD) for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for 28 weeks (double-blind extension period).	Povorcitinib 45 mg n=43 Participants Participants received oral povorcitinib 45 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 45 mg QD for an additional 28 weeks (double-blind extension period).	Povorcitinib 75 mg n=42 Participants Participants received oral povorcitinib 75 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period).
Percentage of Participants Achieving T-VASI50 at Week 24	2.3 percentage of participants Interval 0.1 to 12.3	9.3 percentage of participants Interval 2.6 to 22.1	11.6 percentage of participants Interval 3.9 to 25.1	4.8 percentage of participants Interval 0.6 to 16.2

SECONDARY outcome

Timeframe: up to Week 24

Population: Safety Population: all participants who received at least 1 dose of study drug. Treatment groups for this population were to have been determined according to the actual treatment the participant received on Day 1.

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up period.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Participants received matching placebo QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period).	Povorcitinib 15 mg n=43 Participants Participants received oral povorcitinib 15 milligrams (mg) once daily (QD) for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for 28 weeks (double-blind extension period).	Povorcitinib 45 mg n=41 Participants Participants received oral povorcitinib 45 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 45 mg QD for an additional 28 weeks (double-blind extension period).	Povorcitinib 75 mg n=42 Participants Participants received oral povorcitinib 75 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period).
Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	24 Participants	29 Participants	30 Participants	35 Participants

SECONDARY outcome

Timeframe: from Week 25 up to Week 76

Population: Extension Evaluable Population: all participants who received at least 1 dose of povorcitinib during the double-blind extension period

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up period.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Participants received matching placebo QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period).	Povorcitinib 15 mg n=37 Participants Participants received oral povorcitinib 15 milligrams (mg) once daily (QD) for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for 28 weeks (double-blind extension period).	Povorcitinib 45 mg n=32 Participants Participants received oral povorcitinib 45 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 45 mg QD for an additional 28 weeks (double-blind extension period).	Povorcitinib 75 mg n=34 Participants Participants received oral povorcitinib 75 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period).
Extension Period: Number of Participants With Any TEAE	27 Participants	28 Participants	21 Participants	31 Participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Povorcitinib 15 mg

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Povorcitinib 45 mg

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Povorcitinib 75 mg

Serious events: 1 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=42 participants at risk Participants received matching placebo QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period).	Povorcitinib 15 mg n=43 participants at risk Participants received oral povorcitinib 15 milligrams (mg) once daily (QD) for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for 28 weeks (double-blind extension period).	Povorcitinib 45 mg n=41 participants at risk Participants received oral povorcitinib 45 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 45 mg QD for an additional 28 weeks (double-blind extension period).	Povorcitinib 75 mg n=114 participants at risk Participants received placebo, oral povorcitinib 15 mg QD, or oral povorcitinib 75 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period).
Injury, poisoning and procedural complications Acetabulum fracture	2.4% 1/42 • Number of events 1 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).	0.00% 0/43 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).	0.00% 0/41 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).	0.00% 0/114 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).
Infections and infestations COVID-19	0.00% 0/42 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).	0.00% 0/43 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).	2.4% 1/41 • Number of events 1 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).	0.00% 0/114 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).
Injury, poisoning and procedural complications Pelvic fracture	2.4% 1/42 • Number of events 1 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).	0.00% 0/43 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).	0.00% 0/41 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).	0.00% 0/114 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).
Injury, poisoning and procedural complications Road traffic accident	2.4% 1/42 • Number of events 1 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).	0.00% 0/43 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).	0.00% 0/41 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).	0.00% 0/114 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).
Injury, poisoning and procedural complications Spinal fracture	2.4% 1/42 • Number of events 1 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).	0.00% 0/43 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).	0.00% 0/41 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).	0.00% 0/114 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).
Psychiatric disorders Substance-induced psychotic disorder	0.00% 0/42 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).	0.00% 0/43 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).	0.00% 0/41 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).	0.88% 1/114 • Number of events 1 • up to Week 76 Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).

Other adverse events

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Publication restrictions are in place

Restriction type: OTHER