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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa, Acne Inversa

In brief

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).

Key facts

Study ID

NCT04476043

Run by

Incyte Corporation

People needed

209

Starts

2020-08-25

Expected to finish

2023-08-16

Last updated by the study team

2025-08-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Investigative Site 005 — Hoover, Alabama, United States
• Investigative Site 003 — Gilbert, Arizona, United States
• Investigative Site 011 — Phoenix, Arizona, United States
• Investigative Site 014 — Fountain Valley, California, United States
• Investigative Site 010 — Fremont, California, United States
• Investigative Site 012 — Huntington Beach, California, United States
• Investigative Site 022 — Newbury Park, California, United States
• Investigative Site 009 — Sacramento, California, United States
• Investigative Site 025 — Cromwell, Connecticut, United States
• Investigative Site 015 — Coral Gables, Florida, United States
• Investigative Site 021 — Miami, Florida, United States
• Investigative Site 006 — Tampa, Florida, United States
• Investigative Site 001 — Tampa, Florida, United States
• Investigative Site 016 — Atlanta, Georgia, United States
• Investigative Site 002 — West Lafayette, Indiana, United States
• Investigative Site 027 — Baton Rouge, Louisiana, United States
• Investigative Site 023 — New Orleans, Louisiana, United States
• Investigative Site 013 — Boston, Massachusetts, United States
• Investigative Site 004 — Fort Gratiot, Michigan, United States
• Investigative Site 019 — St Louis, Missouri, United States
• Investigative Site 026 — The Bronx, New York, United States
• Investigative Site 008 — Chapel Hill, North Carolina, United States
• Investigative Site 017 — Winston-Salem, North Carolina, United States
• Investigative Site 007 — Hershey, Pennsylvania, United States
• Investigative Site 018 — Bellaire, Texas, United States

Full record on ClinicalTrials.gov

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