A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)

Hidradenitis Suppurativa (HS) Clinical Trial

— STOP-HS2  

Official title:

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05620836
• Other study ID #: INCB 54707-302
• Status: Recruiting
• Phase: Phase 3
• Start date: February 22, 2023
• Est. completion date: January 30, 2026

Study information

• Verified date: May 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo-controlled period, followed by a 42-week extension period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 30, 2026
• Est. primary completion date: March 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female participants = 18 years of age.
• Diagnosis of moderate to severe HS = 3 months prior to Screening visit.
• HS lesions present in = 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the Screening and Baseline visits.
• Total abscess and inflammatory nodule (AN) count = 5 at both the Screening and Baseline visits.
• History of inadequate response to an appropriate course of at least 1 conventional systemic therapy for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for HS)
• Agree to not use certain topical antiseptics on the areas affected by HS lesions during the placebo-controlled period.
• Willingness to avoid pregnancy or fathering children.
• Other inclusion criteria apply.

Exclusion Criteria:

• Draining tunnel count of > 20 at Screening or Baseline visits.
• Women who are pregnant (or who are considering pregnancy) or breastfeeding.
• Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
• Evidence of infection with TB, HBV, HCV or HIV.
• History of failure to JAK inhibitor treatment of any inflammatory disease.
• Laboratory values outside of the protocol-defined ranges.
• Other exclusion criteria apply.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa
• Hidradenitis Suppurativa (HS)

Intervention

Drug:
• Povorcitinib
Oral, Tablet
• Placebo
Oral, Tablet

Locations

Country	Name	City	State
Australia	Investigative Site AU202	Benowa	Queensland
Australia	Investigative Site AU201	Carlton	Victoria
Australia	Investigative Site AU205	Kogarah	New South Wales
Australia	Investigative Site AU203	Kotara	New South Wales
Australia	Investigative Site AU200	Liverpool	New South Wales
Australia	Investigative Site AU204	Melbourne	Victoria
Australia	Investigative Site AU206	Woolloongabba	Queensland
Australia	Investigative Site AU207	Woolloongabba	Queensland
Bulgaria	Investigative Site BG200	Sofia
Bulgaria	Investigative Site BG202	Sofia
Bulgaria	Investigative Site BG203	Sofia
Bulgaria	Investigative Site BG204	Sofia
Bulgaria	Investigative Site BG201	Stara Zagora
Canada	Investigative Site CA202	Calgary	Alberta
Canada	Investigative Site CA204	Edmonton	Alberta
Canada	Investigative Site CA205	Fredericton	New Brunswick
Canada	Investigative Site CA207	Mississauga	Ontario
Canada	Investigative Site CA209	Quebec
Canada	Investigative Site CA208	Richmond Hill	Ontario
Canada	Investigative Site CA206	St-jérôme	Quebec
Canada	Investigative Site CA203	St. John's
Canada	Investigative Site CA200	Surrey	British Columbia
Denmark	Investigative Site DK200	Århus N
Denmark	Investigative Site DK201	Roskilde
France	Investigative Site FR200	Antony
France	Investigative Site FR205	Dijon
France	Investigative Site FR204	Lyon
France	Investigative Site FR203	Nice Cedex 3
France	Investigative Site FR206	Reims
France	Investigative Site FR202	Rouen Cedex
France	Investigative Site FR201	Toulon
Germany	Investigative Site DE202	Berlin
Germany	Investigative Site DE203	Bochum
Germany	Investigative Site DE201	Dessau
Germany	Investigative Site DE207	Erlangen
Germany	Investigative Site US225	Frankfurt Am Main	MA
Germany	Investigative Site DE208	Gottingen
Germany	Investigative Site DE205	Heidelberg
Germany	Investigative Site DE200	Kiel
Germany	Investigative Site DE204	Luebeck
Germany	Investigative Site DE206	Mainz
Italy	Investigative Site IT200	Ancona
Italy	Investigative Site IT204	Brescia
Italy	Investigative Site IT207	Catania
Italy	Investigative Site IT202	Milano
Italy	Investigative Site IT203	Napoli
Italy	Investigative Site IT206	Pisa
Italy	Investigative Site IT205	Roma
Italy	Investigative Site IT201	Rozzano
Poland	Investigative Site PL203	Lublin
Poland	Investigative Site PL200	Rzeszow
Poland	Investigative Site PL201	Warszawa
Poland	Investigative Site PL202	Warszawa
Spain	Investigative Site ES203	Alicante
Spain	Investigative Site ES202	Las Palmas de Gran Canaria
Spain	Investigative Site ES201	Madrid
Spain	Investigative Site ES204	Madrid
Spain	Investigative Site ES205	Madrid
Spain	Investigative Site ES200	Manises
United Kingdom	Investigative Site GB202	Birmingham
United Kingdom	Investigative Site GB200	Dudley
United Kingdom	Investigative Site GB201	Leeds
United Kingdom	Investigative Site GB204	London
United Kingdom	Investigative Site GB203	Salford
United States	Investigative Site US243	Albuquerque	New Mexico
United States	Investigative Site US214	Arkansas	Arkansas
United States	Investigative Site US235	Arlington	Texas
United States	Investigative Site US224	Baltimore	Maryland
United States	Investigative Site US218	Bellaire	Texas
United States	Investigative Site US208	Beverly	Massachusetts
United States	Investigative Site US215	Bexley	Ohio
United States	Investigative Site US228	Brandon	Florida
United States	Investigative Site US205	Chapel Hill	North Carolina
United States	Investigative Site US203	Columbus	Ohio
United States	Investigative Site US213	Detroit	Michigan
United States	Investigative Site US242	Fayetteville	Arkansas
United States	Investigative Site US230	Hightstown	New Jersey
United States	Investigative Site US206	Indianapolis	Indiana
United States	Investigative Site US241	Iowa City	Iowa
United States	Investigative Site US223	Los Angeles	California
United States	Investigative Site US209	Louisville	Kentucky
United States	Investigative Site US227	Margate	Florida
United States	Investigative Site US207	Metairie	Louisiana
United States	Investigative Site US204	Miami	Florida
United States	Investigative Site US236	Miami	Florida
United States	Investigative Site US212	Minneapolis	Minnesota
United States	Investigative Site US232	Murfreesboro	Tennessee
United States	Investigative Site US229	New Orleans	Louisiana
United States	Investigative Site US202	New York	New York
United States	Investigative Site US200	Ocala	Florida
United States	Investigative Site US239	Omaha	Nebraska
United States	Investigative Site US238	Pflugerville	Texas
United States	Investigative Site US221	Quincy	Massachusetts
United States	Investigative Site US210	Rochester	New York
United States	Investigative Site US234	San Antonio	Texas
United States	Investigative Site US226	San Diego	California
United States	Investigative Site US222	San Francisco	California
United States	Investigative Site US237	Scottsdale	Arizona
United States	Investigative Site US240	Scottsdale	Arizona
United States	Investigative Site US201	Tampa	Florida
United States	Investigative Site US233	Washington	District of Columbia
United States	Investigative Site US217	Waterford	Michigan
United States	Investigative Site US220	West Dundee	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  Denmark,  France,  Germany,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)	HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.	Week 12
Secondary	Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)	HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.	Week 12
Secondary	Proportion of participants with flare	Participants who experience at least 1 flare over 12 weeks; flare is defined as at least a 25% increase in the total abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline.	12 Weeks
Secondary	Proportion of participants with a = 3-point decrease in Skin Pain Numeric Rating Scale (NRS) score among participants with baseline Skin Pain NRS score = 3	Participants with a Skin Pain score of at least 3 at baseline and who experience at least a 3-point decrease in Skin Pain score at Week 12, relative to baseline. Skin Pain is an 11-point NRS, ranging from 0 (no skin pain) to 10 (worst skin pain).	Week 12
Secondary	Proportion of participants who achieve Skin Pain NRS30 at Week 12 among participants with baseline Skin Pain NRS score = 3.	Participants with a Skin Pain score of at least 3 at baseline and who achieve at Week 12 Skin Pain NRS30, defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.	Week 12
Secondary	Proportion of participants with a = 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score	Participants with a baseline FACIT-F score = 48 and who experience at least a 4-point increase in FACIT-F score at Week 12, relative to baseline. The FACIT-F scale is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days, with scores ranging from 0 (worst fatigue) to 52 (no fatigue).	Week 12
Secondary	Mean change from baseline in Dermatology Life Quality Index (DLQI) score	The DLQI is a skin disease specific questionnaire aimed at the evaluation of how symptoms and treatment affect participants' health-related quality of life (QoL). The DLQI total score ranges from 0 to 30, with higher scores indicating lower skin health related QoL.	54 weeks
Secondary	Mean change from baseline in abscess count	Defined as mean change of abscess(es) count relative to baseline.	54 weeks
Secondary	Percentage change from baseline in abscess count	Percent Change from baseline in number of abscess(es)	54 weeks
Secondary	Mean change from baseline in inflammatory nodule count	Defined as mean change of inflammatory nodule count relative to baseline.	54 weeks
Secondary	Percentage change from baseline in inflammatory nodule count	Defined as percent change from baseline in number of inflammatory nodule(s)	54 weeks
Secondary	Mean change from baseline in draining tunnel count	Defined as mean change of draining tunnel count relative to baseline.	54 weeks
Secondary	Percentage change from baseline in draining tunnel count	Defined as Percent change from baseline in number of draining tunnel(s)	54 weeks
Secondary	Extension Period: Proportion of participants who achieve HiSCR	HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.	Week 24
Secondary	Extension Period: Proportion of participants who achieve HiSCR75	HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.	Week 24
Secondary	Extension Period: Proportion of participants with flare	Participants who experience at least 1 flare over the period under assessment; flare is defined as at least a 25% increase in the total abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline.	From Week 12 through Week 24
Secondary	Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score = 3.	Skin Pain NRS30 defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.	Week 24
Secondary	Extension Period: Proportion of participants who achieve HiSCR	HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.	Week 54
Secondary	Extension Period: Proportion of participants who achieve HiSCR75	HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.	Week 54
Secondary	Extension Period: Proportion of participants with flare	Participants who experience at least 1 flare over the period under assessment; flare is defined as at least a 25% increase in the total abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline	From Week 12 through Week 54
Secondary	Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score = 3.	Participants with a Skin Pain score of at least 3 at baseline and who achieve Skin Pain NRS30, defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.	Week 54
Secondary	Extension Period: Proportion of participants who achieve maintenance of HiSCR or greater response at each visit	Maintenance of response defined as participants who achieve HiSCR at Week 12 and maintain it or achieve greater response at each visit during the EXT period.	From Week 12 through Week 54
Secondary	Extension Period: Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit	Maintenance of response defined as participants who achieve HiSCR75 at Week 12 and maintain it or achieve greater response at each visit during the EXT period.	From Week 12 through Week 54