CompletedPhase 2
Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
Key facts
- Who runs it
- Incyte Corporation
- Where
- Baton Rouge, Boca Raton, Boston, Fountain Valley, Marietta, Murfreesboro, New Orleans, New York, Pflugerville, Phoenix, Plymouth Meeting, San Antonio, Spokane, Tampa, and Troy, United StatesSee the 15 sitesAlso in 1 other country, 5 sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 69 people enrolled
- Started
- 7 Dec 2022
- Ended
- 14 Mar 2024
- Type of study
- Interventional, 2 groups
- Treatments tested
- Ruxolitinib cream
- Vehicle cream
- Record updated
- 1 November 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Use of any prohibited medications per protocol-defined criteria
- 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
- Presence of draining tunnels at screening or at baseline visits
- Pregnant or lactating participants, or those considering pregnancy during the period of their study participation
- Other exclusion criteria may apply
Where in United States
Also in 1 other country, 5 sites
- DelRicht ResearchBaton Rouge, United StatesNo longer taking part
- Skin Care Research, Llc Scr HollywoodBoca Raton, United StatesNo longer taking part
- Beth Israel Deaconess Medical CenterBoston, United StatesNo longer taking part
- First OC DermatologyFountain Valley, United StatesNo longer taking part
- Marietta Dermatology & The Skin Cancer Center - MariettaMarietta, United StatesNo longer taking part
- International Clinical Research - Tennessee LLCMurfreesboro, United StatesNo longer taking part
- Delricht ResearchNew Orleans, United StatesNo longer taking part
- Dr Bobby Buka, Md Greenwich VillageNew York, United StatesNo longer taking part
- Austin Institute For Clinical Research Aicr PflugervillePflugerville, United StatesNo longer taking part
- Medical Dermatology Specialists PhoenixPhoenix, United StatesNo longer taking part
- Dermatology Associates of Plymouth MeetingPlymouth Meeting, United StatesNo longer taking part
- Progressive Clinical ResearchSan Antonio, United StatesNo longer taking part
- Dermatology Specialists of SpokaneSpokane, United StatesNo longer taking part
- ForCare Clinical ResearchTampa, United StatesNo longer taking part
- Revival Research Institute, Llc TroyTroy, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Ruxolitinib CreamTreatment being tested
Ruxolitinib 1.5% cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.
- Vehicle CreamTreatment being tested
Vehicle cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 2, Double-Blind, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
- Record updated
- 1 November 2024