A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Children (Ages≥ 2 Years to < 12 Years) With Atopic Dermatitis ((TRuE-AD3)
Overview
- Phase
- Phase 3
- Intervention
- Ruxolitinib
- Conditions
- Atopic Dermatitis
- Sponsor
- Incyte Corporation
- Enrollment
- 330
- Locations
- 67
- Primary Endpoint
- VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children with Atopic Dermatitis. This is a randomized, double-blind, Vehicle Controlled study. Participants will be randomized 2:2:1 to blinded treatment with ruxolitinib cream 0.75% ,1.5% , or vehicle cream, with stratification by baseline IGA score and age. At Week 8, efficacy will be evaluated. Participants who complete Week 8 assessments with no additional safety concerns will continue into the 44-week Long Term Safety (LTS) period with the same treatment regimen, except those initially randomized to vehicle cream will be rerandomized (1:1) in a blinded manner to 1 of the 2 active treatment groups (ruxolitinib cream 0.75% or 1.5%).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants diagnosed with Atopic Dermatitis (AD) as defined by the Hanifin and Rajka criteria.
- •Participants with AD duration of at least 3 months (participant/parent/guardian may verbally report signs and symptoms of AD with onset at least 3 months prior).
- •Participants with IGA score of 2 to 3 at the screening and baseline visits.
- •Participants with %BSA (excluding scalp) of AD involvement of 3% to 20% at screening and baseline visits.
- •For children aged 6 years to \< 12 years, baseline itch NRS score ≥
- •Participants/guardians who agree to discontinue all agents used by the participant to treat AD from the screening visit through the final safety follow-up visit.
- •Participants with at least 1 target lesion that measures at least 5 cm2 at the screening and baseline visits. The target lesion must be representative of the participant's disease state but not located on the hands, feet, or genitalia.
- •Willingness to avoid pregnancy or fathering a child for the duration of study participation.
Exclusion Criteria
- •An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks before the baseline visit.
- •Concurrent conditions and history of other diseases as follows:
- •Immunocompromised
- •Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit.
- •Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit.
- •Any other concomitant skin disorder, 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.
- •Chronic asthma requiring more than 880 µg of inhaled budesonide or equivalent high dose of other inhaled corticosteroids.
- •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 drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Arms & Interventions
Ruxolitinib (1.5% Cream)
Study drug will be administered twice daiily.
Intervention: Ruxolitinib
Ruxolitinib (0.75% cream)
Study drug will be administered twice daily.
Intervention: Ruxolitinib
Vehicle Cream
Vehicle cream will be administered twice daily.
Intervention: Vehicle Cream
Outcomes
Primary Outcomes
VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8
Time Frame: Baseline to Week 8
The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥2 grade improvement from Baseline.
Secondary Outcomes
- VC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)(from Baseline up to Week 8)
- LTS Period: Number of Participants With Any TEAE(From Week 8 up to Week 56)
- VC Period: Percentage of Participants Who Achieved IGA-TS at Weeks 2 and 4(Baseline to Weeks 2 and 4)
- VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8(Baseline to Week 8)
- VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 7 (Week 1)(Baseline to Day 7 (Week 1))
- VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 3(Baseline to Day 3)
- VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Week 2 and 4(Baseline to Weeks 2 and 4)
- VC Period: Number of Participants With Any Grade 3 or Higher TEAE(from Baseline up to Week 8)
- LTS Period: Number of Participants With Any Grade 3 or Higher TEAE(From Week 12 up to Week 56)
- VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Weeks 2, 4, and 8(Baseline to Weeks 2, 4, and 8)
- VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2 or 4 Points(up to Week 8)