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

Hidradenitis Suppurativa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05635838
• Other study ID #: INCB 18424-221
• Status: Completed
• Phase: Phase 2
• Start date: December 7, 2022
• Est. completion date: March 14, 2024

Study information

• Verified date: March 2024
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: March 14, 2024
• Est. primary completion date: October 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
• Vehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

Locations

Country	Name	City	State
Canada	Dr.Wei Jing Loo Medicine Professional Corp	London	Ontario
Canada	Lynderm Research Inc	Markham	Ontario
Canada	Skin Centre For Dermatology	Peterborough	Ontario
Canada	Xlr8 Medical Research	Windsor	Ontario
Canada	Wiseman Dermatology Research Inc	Winnipeg	Manitoba
United States	Delricht Research	Baton Rouge	Louisiana
United States	Skin Care Research, Llc Scr Hollywood	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	First Oc Dermatology	Fountain Valley	California
United States	Marietta Dermatology the Skin Cancer Center Marietta	Marietta	Georgia
United States	International Clinical Research Tennessee Llc	Murfreesboro	Tennessee
United States	Delricht Research	New Orleans	Louisiana
United States	Dr Bobby Buka, Md Greenwich Village	New York	New York
United States	Austin Institute For Clinical Research Aicr Pflugerville	Pflugerville	Texas
United States	Medical Dermatology Specialists Phoenix	Phoenix	Arizona
United States	Dermatology Associates of Plymouth Meeting	Plymouth Meeting	Pennsylvania
United States	Progressive Clinical Research	San Antonio	Texas
United States	Dermatology Specialists of Spokane	Spokane	Washington
United States	Forcare Clinical Research	Tampa	Florida
United States	Revival Research Institute, Llc Troy	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of participants achieving AN50	Defined as at least 50% reduction respectively in AN count relative to baseline.	Week 16
Secondary	Proportion of participants achieving AN75	Defined as at least 75% reduction respectively in AN count relative to baseline.	Week 16
Secondary	Proportion of participants achieving AN90	Defined as at least 90% reduction respectively in AN count relative to baseline.	Week 16
Secondary	Proportion of participants achieving AN100	Defined as 100% reduction respectively in AN count relative to baseline.	Week 16
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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