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A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa

NCT05620823•Incyte Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit.
•Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits
•HS lesions in at least 2 distinct anatomical areas (examples include but are not limited to left and right axilla or left and right inguinocrural fold), 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the screening and baseline visits
•Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their HS).
•Agreement to NOT use topical and systemic antibiotics for treatment of HS during the placebo-controlled period.
•Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the placebo-controlled period. Note: Over-the-counter soap and water is allowed.
•Agreement to use contraception
•Willing and able to comply with the study protocol and procedures.

Exclusion Criteria

•Presence of \> 20 draining tunnels (fistulas) at either the screening or baseline visit.
•Women who are pregnant (or who are considering pregnancy) or breastfeeding.
•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.
•Laboratory values outside of the protocol-defined ranges.

Locations (104)

Investigative Site US303

Phoenix, Arizona, United States

Investigative Site US335

Arkansas City, Arkansas, United States

Investigative Site US307

Fort Smith, Arkansas, United States

Investigative Site US315

Laguna Niguel, California, United States

Investigative Site US326

Los Angeles, California, United States

Investigative Site US323

San Francisco, California, United States

Investigative Site US306

Boca Raton, Florida, United States

Investigative Site US320

Boca Raton, Florida, United States

Investigative Site US317

Hialeah, Florida, United States

Investigative Site US338

Margate, Florida, United States

Key Dates

Start Date

December 19, 2022

Primary Completion Date

February 3, 2025

Completion Date

December 23, 2025

Last Updated

February 10, 2026

Enrollment

608

ACTUAL participants

Conditions

Hidradenitis Suppurativa (HS)

Interventions

Povorcitinib

DRUG

Placebo

DRUG

A Study With CIT-013 in HS Patients

NCT06993233

Hidradenitis Suppurativa (HS)

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RECRUITINGNA

Pelashield™ PainGuard™ vs Restrata® in HS Surgery

NCT07316192

Hidradenitis Suppurativa (HS)

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RECRUITINGPHASE1

1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa)

NCT07155239

Hidradenitis Suppurativa (HS)

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: February 10, 2026Data 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.

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A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa

Inclusion Criteria

Exclusion Criteria

A Study With CIT-013 in HS Patients

Pelashield™ PainGuard™ vs Restrata® in HS Surgery

1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa)

A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic

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