NCT04921969已完成3 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 67
- 主要终点
- VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8
研究概览
简要总结
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%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Use of any of the following treatments within the indicated washout period before the baseline visit:
- •5 half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab).
- •4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus).
- •2 weeks - immunizations with activated vaccines; sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted). Note: Live vaccines are not recommended during the VC period.
- •1 week - use of topical treatments for AD (other than bland emollients, eg, Aveeno® creams, ointments, sprays, soap substitutes), such as corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), topical 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.
- •Participants who have previously received JAK inhibitors, systemic or topical. -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, which is thought by the investigator to potentially impact the participant's AD.-
- •Positive serology test results at screening for HIV antibody.
- •Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the baseline visit with another investigational medication or current enrollment in another investigational drug protocol.
- •In the opinion of the investigator, unable or unlikely to comply with the administration schedule and study evaluations.
- •Employees of the sponsor or investigator or otherwise dependents of them.
研究组 & 干预措施
Ruxolitinib (1.5% Cream)
Experimental
Study drug will be administered twice daiily.
干预措施: Ruxolitinib (Drug)
Ruxolitinib (0.75% cream)
Experimental
Study drug will be administered twice daily.
干预措施: Ruxolitinib (Drug)
Vehicle Cream
Placebo Comparator
Vehicle cream will be administered twice daily.
干预措施: Vehicle Cream (Drug)
结局指标
主要结局
VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8
时间窗: 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.
次要结局
- 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)
研究者
研究点 (67)
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