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

Hidradenitis Suppurativa (HS) Clinical Trial

— STOP-HS1  

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: NCT05620823
• Other study ID #: INCB 54707-301
• Status: Recruiting
• Phase: Phase 3
• Start date: December 19, 2022
• 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:

• Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit.
• Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits
• HS lesions in at least 2 distinct anatomical areas (examples include but are not limited to left and right axilla or left and right inguinocrural fold), 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the screening and baseline visits
• Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their HS).
• Agreement to NOT use topical and systemic antibiotics for treatment of HS during the placebo-controlled period.
• Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the placebo-controlled period. Note: Over-the-counter soap and water is allowed.
• Agreement to use contraception
• Willing and able to comply with the study protocol and procedures.
• Further inclusion criteria apply.

Exclusion Criteria:

• Presence of > 20 draining tunnels (fistulas) at either the screening or baseline visit.
• Women who are pregnant (or who are considering pregnancy) or breastfeeding.
• Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
• Laboratory values outside of the protocol-defined ranges.
• Further 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
Austria	Investigative Site AT304	Graz
Austria	Investigative Site 00A	Innsbruck
Austria	Investigative Site AT306	Innsbruck
Austria	Investigative Site AT302	Linz
Austria	Investigative Site AT305	Vienna
Austria	Investigative Site AT301	Wien
Belgium	Investigative Site BE304	Brussels
Belgium	Investigative Site BE300	Bruxelles
Belgium	Investigative Site BE306	Gent
Belgium	Investigative Site BE301	Ghent
Belgium	Investigative Site BE305	Leuven
Belgium	Investigative Site BE302	Liege
Belgium	Investigative Site BE303	Namur
Canada	Investigative Site CA304	Barrie	Ontario
Canada	Investigative Site CA308	Hamilton	Ontario
Canada	Investigative Site CA306	Laval	Quebec
Canada	Investigative Site CA303	London	Ontario
Canada	Investigative Site CA307	Montreal	Quebec
Canada	Investigative Site CA302	Peterborough	Ontario
Canada	Investigative Site CA301	Winnipeg	Manitoba
Czechia	Investigative Site CZ301	Ostrava - Poruba
Czechia	Investigative Site CZ300	Praha 5
France	Investigative Site FR305	Bordeaux
France	Investigative Site FR303	Brest Cedex 2
France	Investigative Site FR307	Le Mans Cedex
France	Investigative Site FR304	Marseille
France	Investigative Site FR302	Nantes Cedex 1
France	Investigative Site FR300	Paris
France	Investigative Site FR301	Saint Priest En Jarez
France	Investigative Site FR306	Toulouse Cedex 9
Germany	Investigative Site DE305	Darmstadt
Germany	Investigative Site DE302	Dresden
Germany	Investigative Site DE306	Duesseldorf
Germany	Investigative Site DE301	Frankfurt Am Main
Germany	Investigative Site DE303	Hamburg
Germany	Investigative Site DE300	Hannover
Germany	Investigative Site DE304	Langenau
Germany	Investigative Site DE307	Memmingen
Greece	Investigative Site GR300	Athens
Greece	Investigative Site GR303	Athens
Greece	Investigative Site GR301	Thessaloniki
Greece	Investigative Site GR302	Thessaloniki
Japan	Investigative Site JP304	Itabashi-ku
Japan	Investigative Site JP305	Kurume-shi
Japan	Investigative Site JP300	Kyoto-shi
Japan	Investigative Site JP301	Nakagami-gun
Japan	Investigative Site JP303	Niigata-shi
Japan	Investigative Site JP307	Nishinomiya-shi
Japan	Investigative Site JP308	Sapporo-shi
Japan	Investigative Site JP302	Sendai-shi
Japan	Investigative Site JP309	Shinjuku-ku
Japan	Investigative Site JP306	Tsukuba-shi
Netherlands	Investigative Site NL302	Breda
Netherlands	Investigative Site NL303	Groningen
Netherlands	Investigative Site NL301	Rotterdam
Poland	Investigative Site PL304	Ostrowiec
Poland	Investigative Site PL303	Poznan
Poland	Investigative Site PL301	Wroclaw
Poland	Investigative Site PL302	Wroclaw
Spain	Investigative Site ES302	Badalona
Spain	Investigative Site ES303	Barcelona
Spain	Investigative Site ES301	Granada
Spain	Investigative Site ES305	Madrid
Spain	Investigative Site ES300	Pontevedra
Spain	Investigative Site ES304	Santiago de Compostela
United States	Investigative Site US318	Beverly	Massachusetts
United States	Investigative Site US306	Boca Raton	Florida
United States	Investigative Site US320	Boca Raton	Florida
United States	Investigative Site US304	Boston	Massachusetts
United States	Investigative Site US310	Brighton	Massachusetts
United States	Investigative Site US327	Chicago	Illinois
United States	Investigative Site US314	Cincinnati	Ohio
United States	Investigative Site US312	Cleveland	Ohio
United States	Investigative Site US325	Columbia	Maryland
United States	Investigative Site US307	Fort Smith	Arkansas
United States	Investigative Site US317	Hialeah	Florida
United States	Investigative Site US324	Kew Gardens	New York
United States	Investigative Site US315	Laguna Niguel	California
United States	Investigative Site US326	Los Angeles	California
United States	Investigative Site US311	Marietta	Georgia
United States	Investigative Site US329	Milwaukee	Wisconsin
United States	Investigative Site US313	Norfolk	Virginia
United States	Investigative Site US321	North Miami Beach	Florida
United States	Investigative Site US316	Orlando	Florida
United States	Investigative Site US303	Phoenix	Arizona
United States	Investigative Site US300	Plano	Texas
United States	Investigative Site US301	Portland	Oregon
United States	Investigative Site US302	Saint Louis	Missouri
United States	Investigative Site US323	San Francisco	California
United States	Investigative Site US319	Skokie	Illinois
United States	Investigative Site US308	Spokane	Washington
United States	Investigative Site US328	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czechia,  France,  Germany,  Greece,  Japan,  Netherlands,  Poland,  Spain, 

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 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 at each visit	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 at each visit.	Defined as mean change of Abscess count relative to baseline.	54 weeks
Secondary	Percentage change from baseline in abscess count at every visit	Percent change from baseline in number of abscess(es)	54 weeks
Secondary	Mean change from baseline in inflammatory nodule count at each visit	Defined as mean change of inflammatory nodule count relative to baseline.	54 weeks
Secondary	Percentage change from baseline in inflammatory nodule count at each visit.	Defined as percent change from baseline in number of inflammatory nodule(s)	54 weeks
Secondary	Mean change from baseline in draining tunnel count at each visit.	Defined as mean change of draining tunnel count relative to baseline.	54 weeks
Secondary	Percentage change from baseline in draining tunnel count at each visit.	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 at Week 24 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