Study Evaluating the Efficacy and Safety of Povorcitinib... | NCT05936567

ID	Type	Description	Link
2022-503062-72-00	Registry Identifier	EU CT Number

Label	Type	Description	Intervention Names
Povorcitinib Dose A	Experimental	Participants will receive dose A of povorcitinib for a 12 week period, followed by dose A for an additional 24 week period.	Drug: Povorcitinib
Povorcitinib Dose B	Experimental	Participants will receive dose B of povorcitinib for a 12 week period, followed by dose B for an additional 24 week period.	Drug: Povorcitinib
Povorcitinib Dose C	Experimental	Participants will receive dose C of povorcitinib for a 12 week period, followed by dose C for an additional 24 week period.	Drug: Povorcitinib
Placebo followed by Povorcitinib Dose A, B, or C	Experimental	Participants will receive placebo for a 12 week period, followed by randomization to either Dose A, Dose B, or Dose C for an additional 24 week period.	Drug: Povorcitinib Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Povorcitinib	Drug	oral; tablet	Placebo followed by Povorcitinib Dose A, B, or C Povorcitinib Dose A Povorcitinib Dose B Povorcitinib Dose C

Measure	Description	Time Frame
Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12	The UAS7 is defined as the 7-day sum of the individual, daily recorded scores for the hive severity score (HSS) and the itch severity score (ISS). The ISS7 is defined as the 7-day sum of the daily ISS scores (ranging from 0 to 3), and the HSS7 is defined as the 7-day sum of the daily HSS scores (ranging from 0 to 3). The UAS7 score is calculated as the sum of the available UAS scores, divided by the number of days that have a UAS score, multiplied by 7. The UAS7 (ranging from 0 to 42) is equal to the ISS7 (ranging from 0 to 21) plus the HSS7 (ranging from 0 to 21). Higher scores represent more intense/severe hives and itching. Change from baseline was calculated as the post-baseline value minus the baseline value.	Baseline; Week 12

Measure	Description	Time Frame
Percentage of Participants Who Achieved UAS7 ≤ 6 (Controlled Disease) at Week 12	The UAS7 is defined as the 7-day sum of the individual, daily recorded scores for the HSS and the ISS. The ISS7 is defined as the 7-day sum of the daily ISS scores (ranging from 0 to 3), and the HSS7 is defined as the 7-day sum of the daily HSS scores (ranging from 0 to 3). The UAS7 score is calculated as the sum of the available UAS scores, divided by the number of days that have a UAS score, multiplied by 7. The UAS7 (ranging from 0 to 42) is equal to the ISS7 (ranging from 0 to 21) plus the HSS7 (ranging from 0 to 21). Higher scores represent more intense/severe hives and itching.

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Center of Alabama		Birmingham	Alabama	35209	United States
Cahaba Dermatology

Label	URL
Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria	View source

ID	Title	Description
FG000	Placebo	Participants were randomized to receive placebo plus standard of care (SOC) with second-generation H1 antihistamines once daily (QD) for 12 weeks during the Placebo-controlled (PC) period.
FG001	Povorcitinib 15 mg QD to 15 mg QD

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 7, 2023	Feb 18, 2026

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

Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12

The UAS7 is defined as the 7-day sum of the individual, daily recorded scores for the hive severity score (HSS) and the itch severity score (ISS). The ISS7 is defined as the 7-day sum of the daily ISS scores (ranging from 0 to 3), and the HSS7 is defined as the 7-day sum of the daily HSS scores (ranging from 0 to 3). The UAS7 score is calculated as the sum of the available UAS scores, divided by the number of days that have a UAS score, multiplied by 7. The UAS7 (ranging from 0 to 42) is equal to the ISS7 (ranging from 0 to 21) plus the HSS7 (ranging from 0 to 21). Higher scores represent more intense/severe hives and itching. Change from baseline was calculated as the post-baseline value minus the baseline value.

Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Treatment groups were determined according to the treatment participants were assigned at the time of randomization. Only participants with available data were analyzed. Mixed model for repeated measures (MMRM): (change from baseline up to Week 12 = treatment + stratification factor [previous anti-immunoglobulin E use - Yes/No] + visit + treatment*visit + baseline measurement + baseline measurement*visit).

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline; Week 12

ID	Title	Description
OG000	Placebo	Participants were randomized to receive placebo plus standard of care (SOC) with second-generation H1 antihistamines once daily (QD) for 12 weeks during the Placebo-controlled (PC) period.
OG001	Povorcitinib 15 mg QD	Participants were randomized to receive povorcitinib 15 milligrams (mg) plus SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period.
OG002	Povorcitinib 45 mg QD	Participants were randomized to receive povorcitinib 45 mg plus SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period.
OG003	Povorcitinib 75 mg QD	Participants were randomized to receive povorcitinib 75 mg plus stable SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period.

Units	Counts
Participants	OG00023 OG00127 OG00227 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-17.90± 2.21 OG001-17.25± 2.09 OG002-19.83± 2.08 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		t-test, 2 sided		0.8298	nominal p-value	least squares mean difference	0.65	Standard Error of the Mean	3.04	2-Sided	95	-5.37	6.68					Superiority
OG000 OG002		t-test, 2 sided

Secondary

Percentage of Participants Who Achieved UAS7 ≤ 6 (Controlled Disease) at Week 12

The UAS7 is defined as the 7-day sum of the individual, daily recorded scores for the HSS and the ISS. The ISS7 is defined as the 7-day sum of the daily ISS scores (ranging from 0 to 3), and the HSS7 is defined as the 7-day sum of the daily HSS scores (ranging from 0 to 3). The UAS7 score is calculated as the sum of the available UAS scores, divided by the number of days that have a UAS score, multiplied by 7. The UAS7 (ranging from 0 to 42) is equal to the ISS7 (ranging from 0 to 21) plus the HSS7 (ranging from 0 to 21). Higher scores represent more intense/severe hives and itching.

Full Analysis Set. Missing postbaseline visits were imputed as non-responders during the PC period. The 95% confidence interval was based on the Clopper-Pearson exact method.

Posted

Number

95% Confidence Interval

percentage of participants

Week 12

ID	Title	Description
OG000	Placebo	Participants were randomized to receive placebo plus standard of care (SOC) with second-generation H1 antihistamines once daily (QD) for 12 weeks during the Placebo-controlled (PC) period.
OG001	Povorcitinib 15 mg QD	Participants were randomized to receive povorcitinib 15 milligrams (mg) plus SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period.
OG002

Secondary

Time to First Achievement of UAS7 ≤ 6 (Controlled Disease) During the Placebo-controlled (PC) Period

Full Analysis Set. Evaluable participants were defined as participants with a baseline UAS7 score and at least one post-baseline UAS7 score. The median time to first achievement of UAS7 ≤ 6 from baseline was estimated using the Kaplan-Meier method. The confidence interval for the median time to first achievement of UAS7 ≤ 6 from baseline was calculated using the method of Brookmeyer and Crowley.

Posted

Median

95% Confidence Interval

days

up to Week 12

ID	Title	Description
OG000	Placebo	Participants were randomized to receive placebo plus standard of care (SOC) with second-generation H1 antihistamines once daily (QD) for 12 weeks during the Placebo-controlled (PC) period.
OG001	Povorcitinib 15 mg QD	Participants were randomized to receive povorcitinib 15 milligrams (mg) plus SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period.

Secondary

Percentage of Participants With UAS7 = 0 at Week 12

The UAS7 is defined as the 7-day sum of the individual, daily recorded scores for the HSS and the ISS. The ISS7 is defined as the 7-day sum of the daily ISS scores (ranging from 0 to 3), and the HSS7 is defined as the 7-day sum of the daily HSS scores (ranging from 0 to 3). The UAS7 (ranging from 0 to 42) is equal to the ISS7 (ranging from 0 to 21) plus the HSS7 (ranging from 0 to 21). Higher scores represent more intense/severe hives and itching.

Full Analysis Set. Missing postbaseline visits were imputed as non-responders during the PC period. The 95% confidence interval was based on the Clopper-Pearson exact method.

Posted

Number

95% Confidence Interval

percentage of participants

Week 12

ID	Title	Description
OG000	Placebo	Participants were randomized to receive placebo plus standard of care (SOC) with second-generation H1 antihistamines once daily (QD) for 12 weeks during the Placebo-controlled (PC) period.
OG001	Povorcitinib 15 mg QD	Participants were randomized to receive povorcitinib 15 milligrams (mg) plus SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period.
OG002	Povorcitinib 45 mg QD

Secondary

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

An adverse event (AE) is defined as 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 was defined as an AE reported for the first time or the worsening of a pre-existing event after the first dose of study drug and until 60 days after the last dose of study drug.

Safety Population: all participants who received at least 1 dose of study drug. Treatment groups were determined according to the actual treatment the participants received regardless of assigned study drug treatment.

Posted

Count of Participants

Participants

up to Week 12

ID	Title	Description
OG000	Placebo	Participants were randomized to receive placebo plus standard of care (SOC) with second-generation H1 antihistamines once daily (QD) for 12 weeks during the Placebo-controlled (PC) period.
OG001	Povorcitinib 15 mg QD	Participants were randomized to receive povorcitinib 15 milligrams (mg) plus SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period.
OG002

Secondary

Extension Period: Number of Participants With Any TEAE

An AE is defined as 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 was defined as an AE reported for the first time or the worsening of a pre-existing event after the first dose of study drug and until 60 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

from Week 12 to Week 44

ID	Title	Description
OG000	Povorcitinib 15 mg QD to 15 mg QD	Participants were randomized to receive povorcitinib 15 milligrams (mg) plus SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period. At the start of the extension (EXT) period, participants initially randomized to placebo were randomly assigned to receive povorcitinib 15 mg QD for 24 weeks. All participants were required to maintain a stable dose of second-generation H1 antihistamine SOC during the study from the time of informed consent until the completion of the post-treatment follow-up visit. Participants returned for a follow-up visit approximately 60 days after their last dose of study drug.
OG001	Povorcitinib 45 mg QD to 45 mg QD

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	Participants were randomized to receive placebo plus standard of care (SOC) with second-generation H1 antihistamines once daily (QD) for 12 weeks during the Placebo-controlled (PC) period.	0	34	3	34	8	34
EG001	Povorcitinib 15 mg QD	Participants were randomized to receive povorcitinib 15 milligrams (mg) plus SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period.	0	33	0	33	10	33
EG002	Povorcitinib 45 mg QD	Participants were randomized to receive povorcitinib 45 mg plus SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period.	0	34	0	34	12	34
EG003	Povorcitinib 75 mg QD	Participants were randomized to receive povorcitinib 75 mg plus stable SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period.	1	35	0	35	17	35
EG004	Placebo to Povorcitinib 15 mg	Participants were randomized to receive placebo plus SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period. At the start of the EXT period, participants initially randomized to placebo were randomly assigned to receive povorcitinib 15 mg QD for 24 weeks. All participants were required to maintain a stable dose of second-generation H1 antihistamine SOC during the study from the time of informed consent until the completion of the post-treatment follow-up visit. Participants returned for a follow-up visit approximately 60 days after their last dose of study drug.	0	9	0	9	5	9
EG005	Placebo to Povorcitinib 45 mg	Participants were randomized to receive placebo plus SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period. At the start of the EXT period, participants initially randomized to placebo were randomly assigned to receive povorcitinib 45 mg QD for 24 weeks. All participants were required to maintain a stable dose of second-generation H1 antihistamine SOC during the study from the time of informed consent until the completion of the post-treatment follow-up visit. Participants returned for a follow-up visit approximately 60 days after their last dose of study drug.	0	7	0	7	5	7
EG006	Placebo to Povorcitinib 75 mg	Participants were randomized to receive placebo plus SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period. At the start of the EXT period, participants initially randomized to placebo were randomly assigned to receive povorcitinib 75 mg QD for 24 weeks. All participants were required to maintain a stable dose of second-generation H1 antihistamine SOC during the study from the time of informed consent until the completion of the post-treatment follow-up visit. Participants returned for a follow-up visit approximately 60 days after their last dose of study drug.	0	10	0	10	4	10
EG007	Povorcitinib 15 mg QD to 15 mg QD	Participants were randomized to receive povorcitinib 15 milligrams (mg) plus SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period. At the start of the extension (EXT) period, participants initially randomized to placebo were randomly assigned to receive povorcitinib 15 mg QD for 24 weeks. All participants were required to maintain a stable dose of second-generation H1 antihistamine SOC during the study from the time of informed consent until the completion of the post-treatment follow-up visit. Participants returned for a follow-up visit approximately 60 days after their last dose of study drug.	0	29	0	29	14	29
EG008	Povorcitinib 45 mg QD to 45 mg QD	Participants were randomized to receive povorcitinib 45 mg plus SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period. At the start of the EXT period, participants initially randomized to placebo were randomly assigned to receive povorcitinib 45 mg QD for 24 weeks. All participants were required to maintain a stable dose of second-generation H1 antihistamine SOC during the study from the time of informed consent until the completion of the post-treatment follow-up visit. Participants returned for a follow-up visit approximately 60 days after their last dose of study drug.	0	30	0	30	16	30
EG009	Povorcitinib 75 mg QD to 75 mg QD	Participants were randomized to receive povorcitinib 75 mg plus stable SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period. At the start of the EXT period, participants initially randomized to placebo were randomly assigned to receive povorcitinib 75 mg QD for 24 weeks. All participants were required to maintain a stable dose of second-generation H1 antihistamine SOC during the study from the time of informed consent until the completion of the post-treatment follow-up visit. Participants returned for a follow-up visit approximately 60 days after their last dose of study drug.	1	32	1	32	17	32

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected33 at risk EG0020 events0 affected34 at risk EG0030 events0 affected35 at risk EG0041 events1 affected9 at risk EG0050 events0 affected7 at risk EG0060 events0 affected10 at risk EG0072 events1 affected29 at risk EG0080 events0 affected30 at risk EG0091 events1 affected32 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected34 at risk EG0012 events2 affected33 at risk EG0022 events2 affected34 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected34 at risk EG0012 events2 affected33 at risk EG0021 events1 affected34 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003
COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected34 at risk EG0011 events1 affected33 at risk EG0021 events1 affected34 at risk EG003
Chronic spontaneous urticaria	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected33 at risk EG0020 events0 affected34 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003
Depression	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003
Fatigue	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0021 events1 affected34 at risk EG003
Folliculitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0021 events1 affected34 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003
Headache	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0004 events3 affected34 at risk EG0012 events2 affected33 at risk EG0027 events5 affected34 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0022 events2 affected34 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003
Hypermetropia	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003
Hypertension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0004 events2 affected34 at risk EG0013 events2 affected33 at risk EG0021 events1 affected34 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected33 at risk EG0020 events0 affected34 at risk EG003
Otitis media	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003
Sinusitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected34 at risk EG0011 events1 affected33 at risk EG0022 events2 affected34 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0012 events1 affected33 at risk EG0020 events0 affected34 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003

ID	Term
D014581	Urticaria
D000080223	Chronic Urticaria
D000799	Angioedema
D011537	Pruritus

ID	Term
D017445	Skin Diseases, Vascular
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D012877	Skin Manifestations
D012816	Signs and Symptoms

ID	Title	Description
BG000	Placebo	Participants were randomized to receive placebo plus standard of care (SOC) with second-generation H1 antihistamines once daily (QD) for 12 weeks during the Placebo-controlled (PC) period.
BG001	Povorcitinib 15 mg QD	Participants were randomized to receive povorcitinib 15 milligrams (mg) plus SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period.
BG002	Povorcitinib 45 mg QD	Participants were randomized to receive povorcitinib 45 mg plus SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period.
BG003	Povorcitinib 75 mg QD	Participants were randomized to receive povorcitinib 75 mg plus stable SOC with second-generation H1 antihistamines QD for 12 weeks during the PC period.
BG004	Total	Total of all reporting groups

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Activated partial thromboplastin time prolonged	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG0030 events0 affected35 at risk EG004
Bile duct stenosis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003
Major depression	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected34 at risk EG0010 events0 affected33 at risk EG0020 events0 affected34 at risk EG003