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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05620836
Other study ID # INCB 54707-302
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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