Clinical trial NCT05635838: Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
Official title: A Phase 2, Double-Blind, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis suppurativa
skin disease
ruxolitinb cream
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2022-12-02
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1 to 1 of 2 treatment groups (ruxolitinib 1.5% cream BID or vehicle cream BID).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16
timeFrame: Baseline; Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16
timeFrame: Baseline; Week 16
measure: Change From Baseline to Week 16 in Total AN Count in Anatomical Areas With Pre-existing ANs at Baseline
timeFrame: Baseline; Week 16
measure: Change From Baseline in Skin Pain Numeric Rating Scale (NRS) Score at Week 16
timeFrame: Baseline; Week 16
measure: Change From Baseline in Itch NRS Score at Week 16
timeFrame: Baseline; Week 16
measure: Percentage of Participants Who Achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
timeFrame: Baseline; Week 16
measure: Change From Baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16
timeFrame: Baseline; Week 16
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) in the Double-blind, Vehicle-controlled (DBVC) Period
timeFrame: up to Week 16 plus 30 days
measure: Number of Participants With Any Grade 3 or Higher TEAE in the DBVC Period
timeFrame: up to Week 16 plus 30 days
measure: Number of Participants With Any TEAE in the Open-label Extension (OLE) Period
timeFrame: from Week 17 up to Week 32 plus 30 days
measure: Number of Participants With Any Grade 3 or Higher TEAE in the OLE Period
timeFrame: from Week 17 up to Week 32 plus 30 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists Phoenix
state: Arizona
city: Fountain Valley
country: United States
facility: First Oc Dermatology
state: California
city: Boca Raton
country: United States
facility: Skin Care Research, Llc Scr Hollywood
state: Florida
city: Tampa
country: United States
facility: Forcare Clinical Research
state: Florida
city: Marietta
country: United States
facility: Marietta Dermatology the Skin Cancer Center Marietta
state: Georgia
city: Baton Rouge
country: United States
facility: Delricht Research
state: Louisiana
city: New Orleans
country: United States
facility: Delricht Research
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Troy
country: United States
facility: Revival Research Institute, Llc Troy
state: Michigan
city: New York
country: United States
facility: Dr Bobby Buka, Md Greenwich Village
state: New York
city: Plymouth Meeting
country: United States
facility: Dermatology Associates of Plymouth Meeting
state: Pennsylvania
city: Murfreesboro
country: United States
facility: International Clinical Research Tennessee Llc
state: Tennessee
city: Pflugerville
country: United States
facility: Austin Institute For Clinical Research Aicr Pflugerville
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane
state: Washington
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc
state: Manitoba
city: London
country: Canada
facility: Dr.Wei Jing Loo Medicine Professional Corp
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Peterborough
country: Canada
facility: Skin Centre For Dermatology
state: Ontario
city: Windsor
country: Canada
facility: Xlr8 Medical Research
state: Ontario
Study officials:
References: