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

Phase 2

Completed

Conditions: Hidradenitis Suppurativa

Interventions: Drug: Ruxolitinib cream
Drug: Vehicle cream

Registration Number: NCT05635838

Lead Sponsor: Incyte Corporation

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 69

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ruxolitinib Cream	Ruxolitinib cream	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.
Vehicle Cream	Vehicle cream	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16	Baseline; Week 16	The mixed model repeated measure (MMRM) included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16	Baseline; Week 16	AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, in AN count relative to Baseline.
Change From Baseline to Week 16 in Total AN Count in Anatomical Areas With Pre-existing ANs at Baseline	Baseline; Week 16	Pre-existing ANs at Baseline were defined as abscesses and/or inflammatory nodules present at Baseline. All new ANs identified during the study in an anatomical area that had pre-existing ANs at Baseline were counted. Any new ANs identified in an anatomical area that was initially free of ANs at Baseline were not counted. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.
Change From Baseline in Skin Pain Numeric Rating Scale (NRS) Score at Week 16	Baseline; Week 16	The Skin Pain NRS is a daily participant-reported measure (24-hour recall) of the worst level of skin pain related to Hidradenitis Suppurativa. The participants rated the pain severity of their Hidradenitis Suppurativa by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described their worst level of pain in the past 24 hours. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.
Change From Baseline in Itch NRS Score at Week 16	Baseline; Week 16	The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity related to Hidradenitis Suppurativa. The participants rated the itch severity of their Hidradenitis Suppurativa by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.
Percentage of Participants Who Achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16	Baseline; Week 16	HiSCR was defined as at least a 50% reduction in AN count with no increase in either abscess or draining fistula counts, relative to Baseline.
Change From Baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16	Baseline; Week 16	The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. IHS4 score was 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). Scores: mild=0-3; moderate=4-10; severe ≥11. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) in the Double-blind, Vehicle-controlled (DBVC) Period	up to Week 16 plus 30 days	An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Number of Participants With Any Grade 3 or Higher TEAE in the DBVC Period	up to Week 16 plus 30 days	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Number of Participants With Any TEAE in the Open-label Extension (OLE) Period	from Week 17 up to Week 32 plus 30 days	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Number of Participants With Any Grade 3 or Higher TEAE in the OLE Period	from Week 17 up to Week 32 plus 30 days	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using CTCAE v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.

Trial Locations

Locations (19): Revival Research Institute, Llc Troy
🇺🇸
Troy, Michigan, United States
International Clinical Research Tennessee Llc
🇺🇸
Murfreesboro, Tennessee, United States
Dermatology Associates of Plymouth Meeting
🇺🇸
Plymouth Meeting, Pennsylvania, United States
Austin Institute For Clinical Research Aicr Pflugerville
🇺🇸
Pflugerville, Texas, United States
Dermatology Specialists of Spokane
🇺🇸
Spokane, Washington, United States
Dr Bobby Buka, Md Greenwich Village
🇺🇸
New York, New York, United States
Skin Centre For Dermatology
🇨🇦
Peterborough, Ontario, Canada
Dr.Wei Jing Loo Medicine Professional Corp
🇨🇦
London, Ontario, Canada
Wiseman Dermatology Research Inc
🇨🇦
Winnipeg, Manitoba, Canada
Xlr8 Medical Research
🇨🇦
Windsor, Ontario, Canada
Progressive Clinical Research
🇺🇸
San Antonio, Texas, United States
Medical Dermatology Specialists Phoenix
🇺🇸
Phoenix, Arizona, United States
First Oc Dermatology
🇺🇸
Fountain Valley, California, United States
Skin Care Research, Llc Scr Hollywood
🇺🇸
Boca Raton, Florida, United States
Forcare Clinical Research
🇺🇸
Tampa, Florida, United States
Marietta Dermatology the Skin Cancer Center Marietta
🇺🇸
Marietta, Georgia, United States
Delricht Research
🇺🇸
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Lynderm Research Inc
🇨🇦
Markham, Ontario, Canada