Study Description
Brief Summary
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.
Condition or Disease
Hidradenitis Suppurativa
Study Design
| Study Type: | Interventional (Clinical Trial) |
| EstimatedĀ Enrollment: | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Double-Blind, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa |
| ActualĀ Study Start Date: | December 07, 2022 |
| EstimatedĀ Primary Completion Date: | December 3, 2023 |
| EstimatedĀ Study Completion Date: | March 25, 2024 |
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 ā¤ 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 ā¤ 10 should affect at least 2 distinct anatomical areas.
- Baseline Skin Pain or Itch NRS score ā„ 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.