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

Incyte

Status and phase: Completed; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Vehicle cream; Drug: Ruxolitinib cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT05635838

INCB 18424-221

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

  1. A total AN count of 3 to ≤ 10, with no draining tunnels at screening and baseline visits. AND
  2. 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:

  1. Active ongoing inflammatory diseases of the skin other than HS that might confound the evaluation of HS.
  2. 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.
  3. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome).
  4. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.
  5. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

69 participants in 2 patient groups

Ruxolitinib Cream

Experimental group

Description:

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.

Treatment:

Drug: Ruxolitinib cream

Vehicle Cream

Experimental group

Description:

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.

Treatment:

Drug: Vehicle cream