A Study to Evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis

Incyte Corporation241 enrolled

Overview

This study is being conducted to establish the efficacy of ruxolitinib cream in participants with moderate AD who had an inadequate response to, or are intolerant to, or contraindicated to topical corticosteroid (TCS)s and topical calcineurin inhibitor (TCI)s.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

241

Conditions

Atopic Dermatitis

Interventions

Ruxolitinib CreamDRUG

Ruxolitinib cream applied topically to the affected area as a thin film twice daily.

Vehicle CreamDRUG

Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults aged ≥ 18 years at screening (Note: Legal adult age for Korea is ≥ 19 years). * Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria. * AD duration of at least 2 years. * IGA score of 3 at screening and Day 1. * EASI score \> 7 at screening and Day 1. * Itch NRS score ≥ 4 at Day 1, defined as the average of the 7 days directly before Day 1, with Itch NRS values available for at least 4 of the 7 days. * %BSA (excluding the scalp) with AD involvement of at least 10% and up to 20% at screening and Day 1. * DLQI score \> 10 at screening and Day 1. * Documented recent history (within 12 months before the screening visit) of inadequate response, intolerance, or contraindication to TCSs and TCIs. * Agree to discontinue all agents used to treat AD from screening through the final follow up visit, except as outlined in the protocol. * Willingness to avoid pregnancy or fathering children based on the criteria as outlined in the protocol. Exclusion Criteria: * Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Day 1. * Concurrent conditions and history of other diseases as follows: * Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome). * Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Day 1. * Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox) within 1 week before Day 1. * Any other concomitant skin disorder (eg, generalized erythroderma, such as Netherton syndrome), pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety. * Presence of AD lesions only on the hands or feet without prior history of involvement of other classic areas of involvement such as the face or the flexural folds. * Other types of eczema within the 6 months prior to screening. Note: Seborrheic dermatitis on the scalp is allowed, as the scalp will not be treated with study cream. * Current or history of hepatitis B or C virus infection. * Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. * Any of the following clinical laboratory test results at screening: * Hemoglobin \< 10 g/dL. * Liver function tests: * AST or ALT ≥ 2 × ULN. * Alkaline phosphatase \> 1.5 × ULN. * Bilirubin \> 1.5 × ULN (isolated bilirubin \> 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%) with the exception of Gilbert's disease. * Estimated glomerular filtration rate \< 30 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration equation). * Positive serology test results for HIV antibody. * Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant. * Use of any of the following treatments within the indicated washout period before Day 1: * 5 half-lives or 12 weeks, whichever is longer: biologic agents. For biologic agents with washout periods longer than 12 weeks (eg, rituximab), consult the medical monitor. * 4 weeks: systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive (eg, JAK inhibitors) or immunomodulating agents (eg, mycophenolate or tacrolimus). * 2 weeks or 5 half-lives, whichever is longer - strong systemic CYP3A4 inhibitors. * 2 weeks: immunizations with live-attenuated vaccines; sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted). Note: COVID-19 vaccination is allowed. • 1 week: use of other topical treatments for AD, other than bland emollients (eg, Aveeno creams, ointments, sprays, soap substitutes), such as antipruritics (eg, doxepin cream), corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), antibiotics, or antibacterial cleansing body wash/soap. Note: Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study. * History of treatment failure with any systemic or topical JAK inhibitor (eg, ruxolitinib, tofacitinib, baricitinib, abrocitinib, upadacitinib) for AD or any other inflammatory condition. * Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 2 weeks prior to the baseline visit and/or intention to have such exposure during the study that is thought by the investigator to potentially impact the participant's AD. * Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before baseline with another investigational medication or current enrollment in another investigational drug protocol. * In the opinion of the investigator, are unable or unlikely to comply with the administration schedule, study evaluations, and procedures (eg, eDiary compliance). Other protocol-defined Inclusion/Exclusion Criteria may apply.

Locations (94)

Outcomes

Primary Outcomes

Percentage of Participants Achieving a ≥75% Improvement in the Eczema Area and Severity Index Score (EASI75) at Week 8

EASI75 was defined as achieving a ≥75% improvement in the EASI score compared to the baseline score. The EASI scoring system is a validated scoring system that grades the physical signs of atopic dermatitis (AD) to provide a measure of AD severity (ranging from 0 to 72). The disease severity strata for the EASI are: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe.

Time frame: Baseline; Week 8

Percentage of Participants With Investigator's Global Assessment Treatment Success (IGA-TS) at Week 8

IGA-TS was defined as achieving an IGA score of 0 or 1 with a ≥2-grade improvement from baseline. The IGA is an overall eczema severity rating on a 0 to 4 scale. 0: clear; no erythema or induration/papulation, no oozing/crusting; there may be minor residual discoloration. 1: almost clear; may be trace faint pink erythema, with almost no induration/papulation, and no oozing/crusting. 2: mild; may be faint pink erythema, with mild induration/papulation and no oozing/crusting. 3: moderate; may be pink-red erythema with moderate induration/papulation and may be some oozing/crusting. 4: severe; may be deep or bright red erythema with severe induration/papulation and with oozing/crusting.

Time frame: Baseline; Week 8

Secondary Outcomes

Percentage of Participants Achieving a ≥4-point Improvement in Itch Numeric Rating Scale (NRS) Score (ITCH4) From Baseline to Week 8

Time frame: Baseline; Week 8

Percentage of Participants Achieving ITCH4 From Baseline to Days 2, 3, and 7

Time frame: Baseline; Days 2, 3, and 7

Vehicle-controlled (VC) Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE )

Time frame: up to Week 12

Data from ClinicalTrials.gov

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Vehicle-controlled Extension Double-blind (VCE DB) Period: Number of Participants With Any TEAE

Time frame: up to 16 weeks (from Week 8 to Week 24)

VCE Escape Arm: Number of Participants With Any TEAE

Time frame: up to 150 days

VC Period: Number of Participants With Any ≥Grade 3 TEAE

Time frame: up to Week 12

VCE DB Period: Number of Participants With Any ≥Grade 3 TEAE

Time frame: up to 16 weeks (from Week 8 to Week 24)

VCE Escape Arm: Number of Participants With Any ≥Grade 3 TEAE

Time frame: up to 150 days

Double-blind Treatment Period: Percentage of Participants Achieving EASI75 From Baseline at Weeks 2, 4, 12, 16, 20, and 24

Time frame: Baseline; Weeks 2, 4, 12, 16, 20, and 24

VCE Escape Arm: Percentage of Participants Achieving EASI75 From Baseline at Weeks 12, 16, 20, and 24

Time frame: Baseline; Weeks 12, 16, 20, and 24

Double-blind Treatment Period: Percentage of Participants With IGA-TS From Baseline at Each Postbaseline Visit Except Week 8

Time frame: Baseline; Weeks 2, 4, 12, 16, 20, and 24

VCE Escape Arm: Percentage of Participants With IGA-TS From Baseline at Weeks 12, 16, 20, and 24

Time frame: Baseline; Weeks 12, 16, 20, and 24

Percentage of Participants Achieving ITCH4 From Baseline to Weeks 2 and 4

Time frame: Baseline; Weeks 2 and 4

Time to Achieve ITCH4 During the VC Period

Time frame: up to Week 8

Time to Achieve ITCH2 During the VC Period

Time frame: up to Week 8

Change From Baseline in Current Itch NRS Score at 5, 15, 30, 45, and 60 Minutes and 2, 4, and 6 Hours Post-initial Dose on Day 1

Time frame: Baseline; Day 1

Percentage of Participants Achieving at Least a 2-point Decrease From Baseline in Current Itch NRS Score at 5, 15, 30, 45, and 60 Minutes and 2, 4, and 6 Hours Post-Initial Dose on Day 1

Time frame: Baseline; Day 1

Percentage of Participants Achieving at Least a 4-point Decrease From Baseline in Current Itch NRS Score at 5, 15, 30, 45, and 60 Minutes and 2, 4, and 6 Hours Post-Initial Dose on Day 1

Time frame: Baseline; Day 1

Double-blind Treatment Period: Percentage of Participants Achieving EASI50 From Baseline at Weeks 2, 4, 8, 12, 16, 20, and 24

Time frame: Baseline; Weeks 2, 4, 12, 16, 20, and 24

Double-blind Treatment Period: Percentage of Participants With EASI90 From Baseline at Weeks 2, 4, 8, 12, 16, 20, and 24

Time frame: Baseline; Weeks 2, 4, 12, 16, 20, and 24

Double-blind Treatment Period: Percentage of Participants Achieving Both EASI75 and IGA-TS at Weeks 2, 4, 8, 12, 16, 20, and 24

Time frame: Baseline; Weeks 2, 4, 12, 16, 20, and 24

Change From Baseline for Atopic Dermatitis-affected %Body Surface Area (BSA) at Weeks 2, 4, and 8 of the Double-blind Treatment Period

Time frame: Baseline; Weeks 2, 4, and 8

Change From Baseline for Atopic Dermatitis-affected %BSA at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period

Time frame: Baseline; Weeks 12, 16, 20, and 24

Change From Baseline for the EASI Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period

Time frame: Baseline; Weeks 2, 4, and 8

Change From Baseline for the EASI Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period

Time frame: Baseline; Weeks 12, 16, 20, and 24

Change From Baseline for the SCORing Atopic Dermatitis (SCORAD) Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period

Time frame: Baseline; Weeks 2, 4, and 8

Change From Baseline for the SCORAD Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period

Time frame: Baseline; Weeks 12, 16, 20, and 24

Change From Baseline for Itch NRS Score at Days 1 Through 56 (8 Weeks)

Time frame: Baseline; Days 1 through 56 (8 weeks)

Change From Baseline for Skin Pain NRS Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period

Time frame: Baseline; Weeks 2, 4, and 8

Change From Baseline for Skin Pain NRS Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period

Time frame: Baseline; Weeks 12, 16, 20, and 24

Time to Open-label Escape Arm

Time frame: up to 16 weeks (from Week 8 to Week 24)

Percentage of Participants in the VCE DB Period Concurrently Meeting All of the Following Criteria: IGA Score ≥3, EASI Score ≥16, Itch NRS Score, ≥4, BSA ≥10%, and Dermatology Life Quality Index (DLQI) Score >10

Time frame: up to 16 weeks (from Week 8 to Week 24)

Time to Participants in the VCE DB Period Concurrently Meeting All of the Following Criteria: IGA Score ≥3, EASI Score ≥16, Itch NRS Score ≥4, BSA ≥10%, and DLQI Score >10

Time frame: up to 16 weeks (from Week 8 to Week 24)

Percentage of Participants Who Experienced a Relapse After Study Treatment Discontinuation

Time frame: up to 30 days following Week 24

Time to First Retreatment During the VCE DB Period

Time frame: up to 16 weeks (from Week 8 to Week 24)

Percentage of Time Off Study Treatment Due to Lesion Clearance During the VCE DB Period

Time frame: from Week 8 to Week 24

Percentage of Time on Study Treatment During the VCE DB Period

Time frame: from Week 8 to Week 24

Double-blind Treatment Period: Percentage of Participants Who Achieved a ≥4-point Improvement in Dermatology Life Quality Index (DLQI) From Baseline at Weeks 2, 4, 8, 12, 16, 20, and 24

Time frame: Baseline; Weeks 2, 4, 12, 16, 20, and 24

Change From Baseline in the DLQI Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period

Time frame: Baseline; Weeks 2, 4, and 8

Change From Baseline in the DLQI Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period

Time frame: Baseline; Weeks 12, 16, 20, and 24

Change From Baseline in the Patient-oriented Eczema Measure (POEM) Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period

Time frame: Baseline; Weeks 2, 4, and 8

Change From Baseline in the POEM Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period

Time frame: Baseline; Weeks 12, 16, 20, and 24

Change From Baseline in the EQ-5D-5L Visual Analog Scale Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period

Time frame: Baseline; Weeks 2, 4, and 8

Change From Baseline in the EQ-5D-5L Visual Analog Scale Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period

Time frame: Baseline; Weeks 12, 16, 20, and 24

Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Score at Weeks 2, 4, and 8 of the Double-blind Treatment Period

Time frame: Baseline; Weeks 2, 4, and 8

Change From Baseline in the HADS Score at Weeks 12, 16, 20, and 24 of the Double-blind Treatment Period

Time frame: Baseline; Weeks 12, 16, 20, and 24

Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Sleep-Related Impairment (8a: 7-day Recall) Score at Weeks 2, 4, and 8

Time frame: Baseline; Weeks 2, 4, and 8

Change From Baseline in the PROMIS Short Form - Sleep-Related Impairment (8a: 7-day Recall) Score at Weeks 12, 16, 20, and 24

Time frame: Baseline; Weeks 12, 16, 20, and 24

Change From Baseline in the PROMIS Short Form - Sleep Disturbance (8b: 7-day Recall) Score at Weeks 2, 4, and 8

Time frame: Baseline; Weeks 2, 4, and 8

Change From Baseline in the PROMIS Short Form - Sleep Disturbance (8b: 7-day Recall) Score at Weeks 12, 16, 20, and 24

Time frame: Baseline; Weeks 12, 16, 20, and 24

Change From Baseline in the Work Productivity and Activity Impairment Questionairre-Atopic Dermatitis (WPAI-AD) Score at Weeks 8 and 24

Time frame: Baseline; Weeks 8 and 24