A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa

Hidradenitis Suppurativa (HS) Clinical Trial

— STOP-HS LTE  

Official title:

A Phase 3, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06212999
• Other study ID #: INCB 54707-312
• Secondary ID: 2023-507204-31-0
• Status: Recruiting
• Phase: Phase 3
• Start date: January 30, 2024
• Est. completion date: December 26, 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 long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa who completed the 54 weeks of study treatment within the originating parent Phase 3 studies (INCB 54707-301 [NCT05620823] or INCB 54707-302 [NCT05620836]).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 960
• Est. completion date: December 26, 2026
• Est. primary completion date: December 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Completion of the study treatment period of the originating parent study (INCB 54707-301 or INCB 54707-302).
• Agreement to use contraception.
• Willing and able to comply with the study protocol and procedures.
• Further inclusion criteria apply.

Exclusion Criteria:

• Participation in the extension study could expose the participant to an undue safety risk.
• Women who are pregnant (or who are considering pregnancy) or breastfeeding.
• Further exclusion criteria apply.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa
• Hidradenitis Suppurativa (HS)

Intervention

Drug:
• Povorcitinib
Oral; Tablet

Locations

Country	Name	City	State
Australia	Investigative Site AU202	Benowa	Queensland
Australia	Investigator Site AU201	Carlton	Victoria
Australia	Investigative Site AU205	Kogarah	New South Wales
Australia	Investigative Site AU203	Kotara	New South Wales
Australia	Investigator Site AU200	Liverpool	New South Wales
Australia	Investigative Site AU204	Melbourne	Victoria
Australia	Investigative Site AU206	Woolloongabba	Queensland
Australia	Investigative Site AU207	Woolloongabba	Queensland
Austria	Investigative Site AT304	Graz
Austria	Investigative Site AT306	Innsbruck
Austria	Investigative Site AT302	Linz
Austria	Investigative Site AT305	Vienna
Austria	Investigative Site AT300	Wien
Belgium	Investigative Site BE300	Brussels
Belgium	Investigative Site BE304	Brussels
Belgium	Investigative Site BE306	Gent
Belgium	Investigative Site BE301	Ghent
Belgium	Investigative Site BE305	Leuven
Belgium	Investigative Site BE302	Liege
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 CA304	Barrie	Ontario
Canada	Investigative Site CA202	Calgary	Alberta
Canada	Investigative Site CA204	Edmonton	Alberta
Canada	Investigative Site CA205	Fredericton	New Brunswick
Canada	Investigative Site CA303	London	Ontario
Canada	Investigative Site CA207	Mississauga	Ontario
Canada	Investigative Site CA307	Montreal	Quebec
Canada	Investigative Site CA302	Peterborough	Ontario
Canada	Investigative Site CA206	St-jérôme	Quebec
Canada	Investigative Site CA203	St. John's	Newfoundland and Labrador
Canada	Investigative Site CA200	Surrey	British Columbia
Canada	Investigative Site CA301	Winnipeg	Manitoba
Czechia	Investigative Site CZ301	Ostrava - Poruba
Czechia	Investigative Site CZ300	Praha 5
Denmark	Investigative Site DK200	Aarhus
Denmark	Investigative Site DK201	Roskilde
France	Investigative Site FR200	Antony
France	Investigative Site FR305	Bordeaux
France	Investigative Site FR303	Brest Cedex 2
France	Investigative Site FR205	Dijon
France	Investigative Site FR307	Le Mans Cedex 9
France	Investigative Site FR204	Lyon
France	Investigative Site FR304	Marseille Cedex 5
France	Investigative Site FR302	Nantes
France	Investigative Site FR203	Nice Cedex 3
France	Investigative Site FR300	Paris
France	Investigative Site FR206	Reims
France	Investigative Site FR202	Rouen
France	Investigative Site FR301	Saint-priest-en-jarez
France	Investigative Site FR201	Toulon
France	Investigative Site FR306	Toulouse
Germany	Investigative Site DE202	Berlin
Germany	Investigative Site DE203	Bochum
Germany	Investigative Site DE305	Darmstadt
Germany	Investigative Site DE201	Dessau
Germany	Investigative Site DE302	Dresden
Germany	Investigative Site DE306	Duesseldorf
Germany	Investigative Site DE207	Erlangen
Germany	Investigative Site DE301	Frankfurt
Germany	Investigative Site DE208	Gottingen
Germany	Investigative Site DE303	Hamburg
Germany	Investigative Site DE300	Hannover
Germany	Investigative Site DE200	Kiel
Germany	Investigative Site DE304	Langenau
Germany	Investigative Site DE205	Leipzig
Germany	Investigative Site DE204	Lubeck
Germany	Investigative Site DE307	Memmingen
Germany	Investigative Site DE206	Merzig
Greece	Investigative Site GR300	Athens
Greece	Investigative Site GR303	Athens
Greece	Investigative Site GR301	Thessaloniki
Greece	Investigative Site GR302	Thessaloniki
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	Rome
Italy	Investigative Site IT201	Rozzano
Japan	Investigative Site JP306	Ibaraki
Japan	Investigative Site JP304	Itabashi-ku
Japan	Investigative Site JP305	Kurume
Japan	Investigative Site JP300	Kyoto
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	Tokyo
Netherlands	Investigative Site NL302	Breda
Netherlands	Investigative Site NL303	Groningen
Netherlands	Investigative Site NL301	Rotterdam
Poland	Investigative Site PL203	Lublin
Poland	Investigative Site PL304	Ostrowiec
Poland	Investigative Site PL303	Poznan
Poland	Investigative Site PL200	Rzeszow
Poland	Investigative Site PL202	Warsaw
Poland	Investigative Site PL201	Warszawa
Poland	Investigative Site PL301	Wroclaw
Poland	Investigative Site PL302	Wroclaw
Spain	Investigative Site ES203	Alicante
Spain	Investigative Site ES302	Badalona
Spain	Investigative Site ES303	Barcelona
Spain	Investigative Site ES301	Granada
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 ES305	Madrid
Spain	Investigative Site ES300	Pontevedra
Spain	Investigative Site ES304	Santiago de Compostela
Spain	Investigative Site ES200	Valencia
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 US224	Baltimore	Maryland
United States	Investigative Site US229	Baton Rouge	Louisiana
United States	Investigative Site US305	Baton Rouge	Louisiana
United States	Investigative Site US218	Bellaire	Texas
United States	Investigative Site US225	Boston	Massachusetts
United States	Investigative Site US304	Boston	Massachusetts
United States	Investigative Site US228	Brandon	Florida
United States	Investigative Site US310	Brighton	Massachusetts
United States	Investigative Site US205	Chapel Hill	North Carolina
United States	Investigative Site US314	Cincinnati	Ohio
United States	Investigative Site US309	Clearwater	Florida
United States	Investigative Site US312	Cleveland	Ohio
United States	Investigative Site US203	Columbus	Ohio
United States	Investigative Site US215	Columbus	Ohio
United States	Investigative Site US230	East Windsor	New Jersey
United States	Investigative Site US324	Forest Hills	New York
United States	Investigative Site US213	Fort Gratiot	Michigan
United States	Investigative Site US307	Fort Smith	Arkansas
United States	Investigative Site US317	Hialeah	Florida
United States	Investigative Site US306	Hollywood	Florida
United States	Investigative Site US320	Hollywood	Florida
United States	Investigative Site US206	Indianapolis	Indiana
United States	Investigative Site US315	Laguna Niguel	California
United States	Investigative Site US223	Los Angeles	California
United States	Investigative Site US209	Louisville	Kentucky
United States	Investigative Site US316	Maitland	Florida
United States	Investigative Site US227	Margate	Florida
United States	Investigative Site US311	Marietta	Georgia
United States	Investigative Site US207	Metairie	Louisiana
United States	Investigative Site US204	Miami	Florida
United States	Investigator Site US212	Minneapolis	Minnesota
United States	Investigative Site US232	Murfreesboro	Tennessee
United States	Investigative Site US202	New York	New York
United States	Investigative Site US313	Norfolk	Virginia
United States	Investigative Site US321	North Miami Beach	Florida
United States	Investigative Site US200	Ocala	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 US318	Portsmouth	New Hampshire
United States	Investigative Site US221	Quincy	Massachusetts
United States	Investigative Site US210	Rochester	New York
United States	Investigative Site US214	Rogers	Arkansas
United States	Investigative Site US302	Saint Louis	Missouri
United States	Investigative Site US226	San Diego	California
United States	Investigative Site US222	San Francisco	California
United States	Investigative Site US319	Skokie	Illinois
United States	Investigative Site US308	Spokane	Washington
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,  Austria,  Belgium,  Bulgaria,  Canada,  Czechia,  Denmark,  France,  Germany,  Greece,  Italy,  Japan,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)	TEAE 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.	up to approximately 56 weeks
Secondary	Proportion of participants with Serious Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE is defined as any untoward medical occurrence that, at any dose, meet at least one of the following criteria: (a) results in death; (b) is life-threatening; (c) requires inpatient hospitalization or prolongation of existing hospitalization; (d) results in persistent or significant disability/incapacity; (e) is a congenital anomaly/birth defect; (f) is an important medical event.	up to approximately 56 weeks
Secondary	Proportion of participants with TEAEs leading to study drug discontinuation	Defined as any TEAE that leads to discontinuation of study drug.	up to approximately 56 weeks
Secondary	Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)	HiSCR is defined as at least a 50% reduction from baseline of parent study in the total abscess and inflammatory nodule (AN) count, with no increase from baseline of parent study in abscess or draining tunnel count.	up to approximately 56 weeks
Secondary	Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)	HiSCR75 is defined as at least a 75% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.	up to approximately 56 weeks
Secondary	Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)	HiSCR90 is defined as at least a 90% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.	up to approximately 56 weeks
Secondary	Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 100 (HiSCR100)	HiSCR100 is defined as a 100% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.	up to approximately 56 weeks
Secondary	Proportion of participants with flare at each visit	Flare is defined as at least a 25% increase in the total AN count with a minimum increase of 2 ANs relative to Week 54.	up to approximately 56 weeks
Secondary	Time to first flare	Time to first flare during the long-term extension study.	up to approximately 56 weeks
Secondary	Mean change from baseline of parent study in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each visit	The HiSQoL is a HS-specific, health-related quality of life (QoL) instrument. The HiSQoL total score ranges from 0 to 68, with higher scores indicating higher disease impact on QoL.	up to approximately 56 weeks
Secondary	Mean change from baseline of parent study 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.	up to approximately 56 weeks
Secondary	Proportion of participants with no increase in abscess and inflammatory nodule (AN) count relative to Week 54 at each visit		up to approximately 56 weeks
Secondary	Proportion of participants with no increase in abscess, inflammatory nodule, and draining tunnel (ANdT) count relative to Week 54 at each visit	ANdT count is defined as the total sum of abscesses, inflammatory nodules, and draining tunnels.	up to approximately 56 weeks
Secondary	Proportion of participants with no increase in draining tunnel count relative to Week 54 at each visit		up to approximately 56 weeks
Secondary	Proportion of participants with a total AN count of 0, 1, or 2 at each visit	AN count defined as the total sum of abscesses and inflammatory nodules.	up to approximately 56 weeks
Secondary	Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit	ANdT count is defined as the total sum of abscesses, inflammatory nodules, and draining tunnels.	up to approximately 56 weeks