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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Double-Blind, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: Ruxolitinib cream
* Drug: Vehicle cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized 1:1 to 1 of 2 treatment groups (ruxolitinib 1.5% cream BID or vehicle cream BID).
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ruxolitinib Cream<br>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. | Drug: Ruxolitinib cream<br>* Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.<br>* Other names: INCB018424 cream;|
| Experimental: Vehicle Cream<br>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. | Drug: Vehicle cream<br>* Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in abscess and inflammatory nodules (AN) count at Week 16. | Defined as total count of abscess and inflammatory nodules. | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving AN50 | Defined as at least 50% reduction respectively in AN count relative to baseline. | Week 16 | 
| Proportion of participants achieving AN75 | Defined as at least 75% reduction respectively in AN count relative to baseline. | Week 16 | 
| Proportion of participants achieving AN90 | Defined as at least 90% reduction respectively in AN count relative to baseline. | Week 16 | 
| Proportion of participants achieving AN100 | Defined as 100% reduction respectively in AN count relative to baseline. | Week 16 | 
| Change from baseline in the Skin Pain Numeric Rating Scale (NRS) | Defined as skin pain severity on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) in the past 24 hours. | Week 16 | 
| Change from baseline in the Itch NRS score | The Itch NRS is defined as itch severity on an 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch) in the past 24 hours. | Week 16 | 
| Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR) | HiSCR is defined as at least 50% reduction in AN count with no increase in either abscess or draining fistula counts, relative to baseline. | Week 16 | 
| Change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) score | IHS4 score is calculated by the number of inflammatory nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). | Week 16 | 
| Number of Treatment Emergent Adverse Events (TEAEs) | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment. | Up to 40 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hidradenitis suppurativa, skin disease, ruxolitinb cream