Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa

Completed · Phase 2

Conditions studied: Hidradenitis Suppurativa

In brief

The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants with Hidradenitis Suppurativa. This is a randomized 16-week double-blind, vehicle-controlled (DBVC) study followed by a 16 week open label extension period (OLE) with an active treatment for participants who complete the DBVC period.

Key facts

Study ID

NCT05635838

Run by

Incyte Corporation

People needed

69

Starts

2022-12-07

Expected to finish

2024-03-14

Last updated by the study team

2024-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of HS based on clinical history and physical examination for at least 3 months.
• Diagnosis of HS (Hurley I or II) with the following:
• A total AN count of 3 to ≤ 10, with no draining tunnels at screening and baseline visits. AND
• The AN count at the screening AND baseline visits:
• AN of 3 should affect at least 1 distinct anatomical area
• AN of > 3 to ≤ 10 should affect at least 2 distinct anatomical areas.
• Baseline Skin Pain or Itch NRS score ≥ 1.
• Agreement to NOT use topical and systemic antibiotics for treatment of HS during the study.
• Agreement to NOT use a diluted beach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the study.
• Willingness to avoid pregnancy or fathering children

You may not qualify if…

• Presence of draining tunnels at screening or at baseline visits.
• Concurrent conditions and history of other diseases:
• Active ongoing inflammatory diseases of the skin other than HS that might confound the evaluation of HS.
• Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of HS AN or compromise participant safety.
• Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome).
• Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.
• Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox, clinically infected AD, or impetigo) within 2 weeks before baseline.
• Laboratory values outside of the protocol-defined criteria.
• Use of any prohibited medications per protocol-defined criteria.
• Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
• Other exclusion criteria may apply.

Where it is running

• Medical Dermatology Specialists Phoenix — Phoenix, Arizona, United States
• First Oc Dermatology — Fountain Valley, California, United States
• Skin Care Research, Llc Scr Hollywood — Boca Raton, Florida, United States
• Forcare Clinical Research — Tampa, Florida, United States
• Marietta Dermatology the Skin Cancer Center Marietta — Marietta, Georgia, United States
• Delricht Research — Baton Rouge, Louisiana, United States
• Delricht Research — New Orleans, Louisiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Revival Research Institute, Llc Troy — Troy, Michigan, United States
• Dr Bobby Buka, Md Greenwich Village — New York, New York, United States
• Dermatology Associates of Plymouth Meeting — Plymouth Meeting, Pennsylvania, United States
• International Clinical Research Tennessee Llc — Murfreesboro, Tennessee, United States
• Austin Institute For Clinical Research Aicr Pflugerville — Pflugerville, Texas, United States
• Progressive Clinical Research — San Antonio, Texas, United States
• Dermatology Specialists of Spokane — Spokane, Washington, United States
• Wiseman Dermatology Research Inc — Winnipeg, Manitoba, Canada
• Dr.Wei Jing Loo Medicine Professional Corp — London, Ontario, Canada
• Lynderm Research Inc — Markham, Ontario, Canada
• Skin Centre For Dermatology — Peterborough, Ontario, Canada
• Xlr8 Medical Research — Windsor, Ontario, Canada

Full record on ClinicalTrials.gov

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