Loading clinical trials...

To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa

NCT04476043•Incyte Corporation

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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.

Locations (40)

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

Key Dates

Start Date

August 25, 2020

Primary Completion Date

December 15, 2021

Completion Date

August 16, 2023

Last Updated

August 12, 2025

Enrollment

209

ACTUAL participants

Conditions

Hidradenitis SuppurativaAcne Inversa

Interventions

INCB054707

DRUG

Placebo

DRUG

A Study With CIT-013 in HS Patients

NCT06993233

Hidradenitis Suppurativa (HS)

View study

RECRUITINGPHASE1

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

NCT06888193

Moderate to Severe Plaque PsoriasisPsoriatic Arthritis+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study With CIT-013 in HS Patients

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

Pelashield™ PainGuard™ vs Restrata® in HS Surgery

An Open-label, Single-arm Study to Evaluate Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents With Moderate to Severe Hidradenitis Suppurativa (VELA-TEEN)

Study to Collect in a Real-world populatIon Data on the Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS) in Routine Clinical Practice in the Russian Federation

A 16-Week Study to Learn About the Study Medicine Called Ritlecitinib in Adults With Long Lasting Painful Red Skin Lumps, Known by the Medical Term, Hidradenitis Suppurativa, or HS.