To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa

NCT04476043 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: INCB 54707-2042020-001981-13
• Study Type: interventional
• Target: 209
• Locations: 6 countries
• Sites: 40

Brief Summary

To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis suppurativa over a 16-week placebo-controlled treatment period followed by a 36-week open-label extension period. All eligible participants will be invited to continue treatment for an additional 48-week Long-term extension period (also open label).

Conditions

Hidradenitis Suppurativa; Acne Inversa

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16

  Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The mixed model repeated measure (MMRM) included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity \[Hurley Stage I, II, and III\] and geographical region \[North America and outside of North America\]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.

  Baseline; Week 16

Secondary Outcomes (10)

• Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16

  Baseline; Week 16

• Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12

  Baseline; Weeks 2, 4, 6, 8, and 12

• Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16

  Baseline; Weeks 2, 4, 6, 8, 12, and 16

• Mean Change From Baseline in the Severity of the Disease, as Assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4) Score, From Weeks 2 to 16

  Baseline; Weeks 2, 4, 6, 8, 12, and 16

• Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16

  Baseline; Weeks 2, 4, 6, 8, 12, and 16

Study Arms (4)

INCB054707 15 mg

EXPERIMENTAL

Participants will receive INCB054707 15 milligrams (mg) for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.

Drug: INCB054707

INCB054707 45 mg

EXPERIMENTAL

Participants will receive INCB054707 45 mg for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.

Drug: INCB054707

INCB054707 75 mg

EXPERIMENTAL

Participants will receive INCB054707 75 mg for 52 weeks in the Placebo-controlled Treatment Period (16 weeks) plus the Open-label Extension Period (36 weeks). Participants will have the option to continue open-label treatment for an additional 48 weeks.

Drug: INCB054707

Placebo followed by INCB054707 75 mg

PLACEBO COMPARATOR

Participants will receive placebo for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.

Drug: Placebo

Interventions

INCB054707 DRUG

Oral; Tablet

Also known as: Povorcitinib

INCB054707 15 mg; INCB054707 45 mg; INCB054707 75 mg

Placebo DRUG

Oral; Tablet

Placebo followed by INCB054707 75 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HS disease duration of at least 3 months before screening.
• Willingness to avoid pregnancy or fathering children.
• Active HS in at least 2 distinct anatomical areas.
• Participants agree NOT to use topical antiseptics on the areas affected by HS lesions during the placebo-controlled 16-week treatment period

You may not qualify if:

• Draining fistula count of \> 20 at screening or baseline.
• Women who are pregnant (or who are considering pregnancy) or lactating.
• 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.
• History of failure to treatment of inflammatory diseases with JAK inhibitors.
• Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
• Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.
• Laboratory values outside of the protocol-defined ranges.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (40)

Investigative Site 005

Hoover, Alabama, 35244, United States

Location

Investigative Site 003

Gilbert, Arizona, 85295, United States

Location

Investigative Site 011

Phoenix, Arizona, 85006, United States

Location

Investigative Site 014

Fountain Valley, California, 92708, United States

Location

Investigative Site 010

Fremont, California, 94538, United States

Location

Investigative Site 012

Huntington Beach, California, 92647, United States

Location

Investigative Site 022

Newbury Park, California, 91320, United States

Location

Investigative Site 009

Sacramento, California, 95815, United States

Location

Investigative Site 025

Cromwell, Connecticut, 06416, United States

Location

Investigative Site 015

Coral Gables, Florida, 33134, United States

Location

Investigative Site 021

Miami, Florida, 33136, United States

Location

Investigative Site 006

Tampa, Florida, 33614, United States

Location

Investigative Site 001

Tampa, Florida, 33624, United States

Location

Investigative Site 016

Atlanta, Georgia, 30328, United States

Location

Investigative Site 002

West Lafayette, Indiana, 47906, United States

Location

Investigative Site 027

Baton Rouge, Louisiana, 70808, United States

Location

Investigative Site 023

New Orleans, Louisiana, 70112, United States

Location

Investigative Site 013

Boston, Massachusetts, 02215, United States

Location

Investigative Site 004

Fort Gratiot, Michigan, 48059, United States

Location

Investigative Site 019

St Louis, Missouri, 63110, United States

Location

Investigative Site 026

The Bronx, New York, 10468, United States

Location

Investigative Site 008

Chapel Hill, North Carolina, 27516, United States

Location

Investigative Site 017

Winston-Salem, North Carolina, 27157, United States

Location

Investigative Site 007

Hershey, Pennsylvania, 17033, United States

Location

Investigative Site 018

Bellaire, Texas, 77401, United States

Location

Investigative Site 101

Calgary, Alberta, T1Y 0B4, Canada

Location

Investigative Site 102

Calgary, Alberta, T3A 0B2, Canada

Location

Investigative Site 304

Nantes, 44093, France

Location

Investigative Site 403

Berlin, 10117, Germany

Location

Investigative Site 401

Bochum, 44791, Germany

Location

Investigative Site 405

Dessau, 06847, Germany

Location

Investigative Site 406

Dresden, 01307, Germany

Location

Investigative Site 404

Erlangen, 91054, Germany

Location

Investigative Site 402

Frankfurt am Main, 60590, Germany

Location

Investigative Site 552

Rzeszów, 35-055, Poland

Location

Investigative Site 551

Wroclaw, 50-566, Poland

Location

Investigative Site 553

Wroclaw, 51-318, Poland

Location

Investigative Site 703

Granada, 18014, Spain

Location

Investigative Site 702

Madrid, 28007, Spain

Location

Investigative Site 701

Valencia, 46940, Spain

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 17, 2020
• Study Start: August 25, 2020
• Primary Completion: December 15, 2021
• Study Completion: August 16, 2023
• Last Updated: August 12, 2025
• Results First Posted: January 26, 2023

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

CA (2); DE (6); FR (1); ES (3); US (25); PL (3)