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

Incyte Corporation69 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hidradenitis Suppurativa

Interventions

Ruxolitinib creamDRUG

Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.

Vehicle creamDRUG

Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (20)

Medical Dermatology Specialists Phoenix

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at 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.

Time frame: Baseline; Week 16

Secondary Outcomes

Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at 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.

Time frame: Baseline; Week 16

Change From Baseline to Week 16 in Total AN Count in Anatomical Areas With Pre-existing ANs at Baseline

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.

Time frame: Baseline; Week 16

Change From Baseline in Skin Pain Numeric Rating Scale (NRS) Score at 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.

Data from ClinicalTrials.gov

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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

Baton Rouge, Louisiana, United States

Delricht Research

New Orleans, Louisiana, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Revival Research Institute, Llc Troy

Troy, Michigan, United States

Dr Bobby Buka, Md Greenwich Village

New York, New York, United States

...and 10 more locations

Time frame: Baseline; Week 16

Change From Baseline in Itch NRS Score at 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.

Time frame: Baseline; Week 16

Percentage of Participants Who Achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at 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.

Time frame: Baseline; Week 16

Change From Baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) Score at 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.

Time frame: Baseline; Week 16

Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) in the Double-blind, Vehicle-controlled (DBVC) Period

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.

Time frame: up to Week 16 plus 30 days

Number of Participants With Any Grade 3 or Higher TEAE in the DBVC Period

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.

Time frame: up to Week 16 plus 30 days

Number of Participants With Any TEAE in the Open-label Extension (OLE) Period

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.

Time frame: from Week 17 up to Week 32 plus 30 days

Number of Participants With Any Grade 3 or Higher TEAE in the OLE Period

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.

Time frame: from Week 17 up to Week 32 plus 30 days