A Study to Evaluate the Efficacy and Safety of INCB054707... | NCT05061693

ID	Type	Description	Link
2021-006329-23	EudraCT Number

Label	Type	Description	Intervention Names
INCB054707 Dose A	Experimental	Participants will receive INCB054707 Dose A for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).	Drug: INCB054707
INCB054707 Dose B	Experimental	Participants will receive INCB054707 Dose B for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).	Drug: INCB054707
INCB054707 Dose C	Experimental	Participants will receive INCB054707 Dose C for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).	Drug: INCB054707
Placebo followed by INCB054707 Dose B or C	Placebo Comparator	Participants will receive placebo for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
INCB054707	Drug	Oral; Tablet	INCB054707 Dose A INCB054707 Dose B INCB054707 Dose C

Measure	Description	Time Frame
Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16	Each evening, the participants assessed their worst level of itch during the past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable). The Baseline Itch NRS score was determined by averaging the 7 daily Itch NRS scores before Day 1 (i.e., Day -7 to Day -1). If ≥4 of the 7 days of the daily Itch NRS scores were missing prior to Day 1, then the Baseline Itch NRS score was set to "missing." The by-visit Itch NRS score for postbaseline visits was determined by averaging the 7 daily Itch NRS scores before the visit day. If 4 or more daily Itch NRS scores out of the 7 days before the visit day were missing, the Itch NRS score at the visit was set to missing.	Baseline; Week 16

Measure	Description	Time Frame
Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) (IGA Score of 0 or 1 With a ≥2-grade Improvement From Baseline) at Week 16	The IGA for chronic prurigo considers the number of pruriginous lesions, which includes papules, nodules, plaques, umbilicated ulcers, and ulcers, and uses them as an overall severity rating on a scale of 0 to 4. 0: clear; no pruriginous lesions (0 lesions). 1: almost clear; rare palpable pruriginous lesions (approximately 1-5 lesions). 2: mild; few palpable pruriginous lesions (approximately 6-19 lesions). 3: moderate: many palpable pruriginous lesions (approximately 20-100 lesions). 4: severe; abundant palpable pruriginous lesions (over 100 lesions). The IGA-TS is defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline.

Name	Affiliation	Role
Kathleen Butler, MD	Incyte Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigative Site US010		Phoenix	Arizona	85006	United States
Investigative Site US024

ID	Title	Description
FG000	PC Period: Placebo	On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
FG001	PC Period: Povorcitinib 15 mg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 6, 2022	Aug 2, 2024

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16

Each evening, the participants assessed their worst level of itch during the past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable). The Baseline Itch NRS score was determined by averaging the 7 daily Itch NRS scores before Day 1 (i.e., Day -7 to Day -1). If ≥4 of the 7 days of the daily Itch NRS scores were missing prior to Day 1, then the Baseline Itch NRS score was set to "missing." The by-visit Itch NRS score for postbaseline visits was determined by averaging the 7 daily Itch NRS scores before the visit day. If 4 or more daily Itch NRS scores out of the 7 days before the visit day were missing, the Itch NRS score at the visit was set to missing.

Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups for this population were defined according to the treatment assignment at randomization. Missing post-Baseline values and rescue therapy recipients for all subsequent visits after the initiation date of rescue therapy were imputed as nonresponders. The 95% confidence interval was based on the Clopper-Pearson exact method.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline; Week 16

ID	Title	Description
OG000	Placebo	On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
OG001	Povorcitinib 15 mg	On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
OG002	Povorcitinib 45 mg	On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
OG003	Povorcitinib 75 mg	On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.

Units	Counts
Participants	OG00037 OG00136 OG00236 OG003

Title

Denominators

Categories

Title	Measurements
	OG0008.1(1.7 to 21.9) OG00136.1(20.8 to 53.8) OG00244.4(27.9 to 61.9) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic	Exact Logistic regression: (response at Week 16 = treatment + stratification factor [Day 1 Investigator's Global Assessment score (3 or 4)])	0.0061		Odds Ratio (OR)	7.1			2-Sided	95	1.6	45.4					Superiority
OG000 OG001

Secondary

Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) (IGA Score of 0 or 1 With a ≥2-grade Improvement From Baseline) at Week 16

The IGA for chronic prurigo considers the number of pruriginous lesions, which includes papules, nodules, plaques, umbilicated ulcers, and ulcers, and uses them as an overall severity rating on a scale of 0 to 4. 0: clear; no pruriginous lesions (0 lesions). 1: almost clear; rare palpable pruriginous lesions (approximately 1-5 lesions). 2: mild; few palpable pruriginous lesions (approximately 6-19 lesions). 3: moderate: many palpable pruriginous lesions (approximately 20-100 lesions). 4: severe; abundant palpable pruriginous lesions (over 100 lesions). The IGA-TS is defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline.

ITT Population. Missing post-Baseline values were imputed as non-responders. The 95% confidence interval was based on the Clopper-Pearson exact method.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline; Week 16

ID	Title	Description
OG000	Placebo	On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
OG001	Povorcitinib 15 mg	On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.

Secondary

Time to ≥4-point Improvement From Baseline in Itch NRS Score

ITT Population. The time to a ≥4-point improvement from Baseline in itch NRS score was estimated using the Kaplan-Meier method. The confidence interval for the median time to a ≥4-point improvement from Baseline was calculated using the method of Brookmeyer and Crowley. Only participants with available data were analyzed.

Posted

Median

95% Confidence Interval

days

up to 122 days

ID	Title	Description
OG000	Placebo	On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
OG001	Povorcitinib 15 mg	On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.

Secondary

PC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug.

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

Posted

Count of Participants

Participants

up to 152 days

ID	Title	Description
OG000	Placebo	On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
OG001	Povorcitinib 15 mg	On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
OG002

Secondary

PC Period: Number of Participants With Any ≥Grade 3 TEAE

A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and serious adverse event (SAE) reported during the study and assigned it to 1 of the following categories. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.

Safety Population

Posted

Count of Participants

Participants

up to 152 days

ID	Title	Description
OG000	Placebo	On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
OG001	Povorcitinib 15 mg	On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.

Secondary

Extension Period: Number of Participants With Any TEAE

An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug.

Extension Evaluable Population: all participants who received at least 1 dose of povorcitinib during the Extension Period

Posted

Count of Participants

Participants

up to 215 days

ID	Title	Description
OG000	Placebo to Povorcitinib 45 mg	Participants who received placebo during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch Numerical Rating Scale (NRS) score and Investigator's Global Assessment-Treatment Success (IGA-TS) who did not receive rescue therapy during the placebo-controlled period.
OG001	Povorcitinib 15 mg to 45 mg	Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.

Secondary

Extension Period: Number of Participants With Any ≥Grade 3 TEAE

Extension Evaluable Population

Posted

Count of Participants

Participants

up to 215 days

ID	Title	Description
OG000	Placebo to Povorcitinib 45 mg	Participants who received placebo during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch Numerical Rating Scale (NRS) score and Investigator's Global Assessment-Treatment Success (IGA-TS) who did not receive rescue therapy during the placebo-controlled period.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.	0	37	1	37	14	37
EG001	Povorcitinib 15 mg	On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.	1	36	2	36	17	36
EG002	Povorcitinib 45 mg	On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.	0	35	4	35	19	35
EG003	Povorcitinib 75 mg	On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.	0	37	3	37	22	37
EG004	Placebo to Povorcitinib 45 mg	Participants who received placebo during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch Numerical Rating Scale (NRS) score and Investigator's Global Assessment-Treatment Success (IGA-TS) who did not receive rescue therapy during the placebo-controlled period.	0	1	0	1	0	1
EG005	Povorcitinib 15 mg to 45 mg	Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.	0	4	0	4	3	4
EG006	Povorcitinib 45 mg to 45 mg	Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for an additional 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.	0	8	0	8	5	8
EG007	Povorcitinib 75 mg to 45 mg	Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period.	0	15	1	15	6	15
EG008	Placebo to Povorcitinib 75 mg	Participants who received placebo during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.	0	30	0	30	15	30
EG009	Povorcitinib 15 mg to 75 mg	Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.	0	25	1	25	15	25
EG010	Povorcitinib 45 mg to 75 mg	Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.	0	23	2	23	13	23
EG011	Povorcitinib 75 mg to 75 mg	Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for an additional 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder.	0	18	3	18	13	18

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG0031 events1 affected37 at risk EG0040 events0 affected1 at risk EG0050 events0 affected4 at risk EG0060 events0 affected8 at risk EG0070 events0 affected15 at risk EG0080 events0 affected30 at risk EG0090 events0 affected25 at risk EG0100 events0 affected23 at risk EG0110 events0 affected18 at risk
Anxiety	Psychiatric disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Appendicitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected35 at risk EG003
COVID-19	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Death	General disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0011 events1 affected36 at risk EG0020 events0 affected35 at risk EG003
Erysipelas	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected35 at risk EG003
Mastitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected35 at risk EG003
Neurodermatitis	Skin and subcutaneous tissue disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Pneumonia	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Tooth infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected35 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0011 events1 affected36 at risk EG0020 events0 affected35 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Aspergillus test positive	Investigations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG0030 events0 affected37 at risk EG0040 events0 affected1 at risk EG0050 events0 affected4 at risk EG0060 events0 affected8 at risk EG0071 events1 affected15 at risk EG0080 events0 affected30 at risk EG0090 events0 affected25 at risk EG0100 events0 affected23 at risk EG0110 events0 affected18 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0012 events2 affected36 at risk EG0023 events3 affected35 at risk EG003
Blepharitis	Eye disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 27	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected35 at risk EG003
Bronchitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0022 events2 affected35 at risk EG003
COVID-19	Infections and infestations	MedDRA 27	Systematic Assessment	EG0002 events2 affected37 at risk EG0012 events2 affected36 at risk EG0022 events2 affected35 at risk EG003
Cellulitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Chest pain	General disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0022 events2 affected35 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0011 events1 affected36 at risk EG0021 events1 affected35 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0011 events1 affected36 at risk EG0022 events2 affected35 at risk EG003
Cystitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected35 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Dizziness	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected35 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0011 events1 affected36 at risk EG0022 events2 affected35 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Ear discomfort	Ear and labyrinth disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Eyelid folliculitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Fatigue	General disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected37 at risk EG0017 events5 affected36 at risk EG0023 events3 affected35 at risk EG003
Folliculitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0011 events1 affected36 at risk EG0021 events1 affected35 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0022 events2 affected35 at risk EG003
Headache	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0017 events6 affected36 at risk EG0028 events6 affected35 at risk EG003
Herpes simplex	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Hypertension	Vascular disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected35 at risk EG003
Influenza	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected35 at risk EG003
Joint capsule rupture	Injury, poisoning and procedural complications	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Lichen myxoedematosus	Skin and subcutaneous tissue disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Loose tooth	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Migraine	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0004 events3 affected37 at risk EG0012 events2 affected36 at risk EG0024 events2 affected35 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0015 events4 affected36 at risk EG0021 events1 affected35 at risk EG003
Neurodermatitis	Skin and subcutaneous tissue disorders	MedDRA 27	Systematic Assessment	EG0003 events3 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0011 events1 affected36 at risk EG0021 events1 affected35 at risk EG003
Oral herpes	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected35 at risk EG003
Perioral dermatitis	Skin and subcutaneous tissue disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Platelet count decreased	Investigations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Pneumonia	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Polyneuropathy	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Presyncope	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Pulpitis dental	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected35 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Sinusitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Skin candida	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Skin infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Tooth infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Trichoglossia	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0011 events1 affected36 at risk EG0020 events0 affected35 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected37 at risk EG0011 events1 affected36 at risk EG0020 events0 affected35 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Weight increased	Investigations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected35 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected37 at risk EG0011 events1 affected36 at risk EG0020 events0 affected35 at risk EG003
Abscess	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Animal scratch	Injury, poisoning and procedural complications	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Ankylosing spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 27	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0011 events1 affected36 at risk EG0020 events0 affected35 at risk EG003
Heavy menstrual bleeding	Reproductive system and breast disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected35 at risk EG003
Myelocyte count increased	Investigations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Platelet count increased	Investigations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Seizure	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 27	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 27	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected35 at risk EG003

ID	Title	Description
BG000	Placebo	On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16.
BG001	Povorcitinib 15 mg	On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
BG002	Povorcitinib 45 mg	On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
BG003	Povorcitinib 75 mg	On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16.
BG004	Total	Total of all reporting groups