A Phase 2, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Achieve a ≥75% Improvement in the Eczema Area and Severity Index Score (EASI75) of the Head and Neck Region at Week 4
研究概览
简要总结
This is a randomized, double blind, vehicle controlled Phase 2 study with a 4-week open label extension in adolescent and adult participants with atopic dermatitis and head and/or neck involvement. It is intended to compare the efficacy and safety of ruxolitinib cream 1.5% BID versus vehicle cream, then further evaluate ruxolitinib cream as maintenance during the open label extension period.
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
- Double (Participant, Investigator)
盲法说明
4 week double-blind treatment
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with diagnosis of AD for at least 6 months.
- •Participants with an overall and a face and/or neck IGA score of 2 or 3 at screening and baseline.
- •Participants with AD affecting the following at screening and baseline:
- •≥ 0.5% of the total BSA on the face and/or neck
- •Up to a total of 20% BSA (face and/or neck plus other body areas)
- •Willingness to avoid pregnancy or fathering children based on the criteria outlined in the protocol.
- •Further inclusion criteria apply.
排除标准
- •Participants who have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to baseline.
- •Participants with concurrent conditions and history of other diseases such as immunocompromised; chronic or acute infection requiring systemic treatments; active acute skin infection; other concomitant skin conditions that may interfere with the evaluation of AD or compromise participant safety; other types of eczema; chronic asthma requiring high dose of 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.
- •Previous treatment with systemic or topical JAK inhibitors (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
- •Participants who are pregnant (or who are considering pregnancy) or lactating.
- •Laboratory values outside of the protocol -defined criteria
- •Further exclusion criteria apply.
研究组 & 干预措施
Double-blind Period: vehicle cream or Ruxolitinib cream 1.5% BID
Participants will be treated with ruxolitinib cream 1.5% or vehicle cream twice a day (BID) in a double-blind fashion.
干预措施: Ruxolitinib cream (Drug)
Double-blind Period: vehicle cream or Ruxolitinib cream 1.5% BID
Participants will be treated with ruxolitinib cream 1.5% or vehicle cream twice a day (BID) in a double-blind fashion.
干预措施: Vehicle (Drug)
Open Label Extension: Ruxolitiib cream 1.5%
Patients will be treated with Ruxoltinib cream 1.5% twice per day (BID) during the open label extension period. Participants who complete the double-blind period will continue into this open-label extension period for an additional 4 weeks of treatment.
干预措施: Ruxolitinib cream (Drug)
结局指标
主要结局
Percentage of Participants Who Achieve a ≥75% Improvement in the Eczema Area and Severity Index Score (EASI75) of the Head and Neck Region at Week 4
时间窗: Baseline; Week 4
The EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72; the severity strata are as follows: 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. Specifically for the head and neck region, the EASI score ranges from 0 to 7.2 An EASI75 responder was defined as a participant achieving a 75% or greater improvement from Baseline in the EASI score for the head and neck.
次要结局
- Percentage of Participants Who Achieve an Overall EASI75 at Weeks 2, 4, and 8(Baseline; Weeks 2, 4, and 8)
- Double-Blind Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)(up to approximately 4 weeks plus 30 days)
- Open-Label Period: Number of Participants With Any Grade 3 or Higher TEAE(from first dose date in Open-Label Period (start of Week 5) until last follow-up visit (up to approximately 4 weeks plus 30 days))
- Percentage of Participants Who Achieve an EASI75 of the Head and Neck Region at Weeks 2 and 8(Baseline; Weeks 2 and 8)
- Open-Label Period: Number of Participants With Any TEAE(from first dose date in Open-Label Period (start of Week 5) until last follow-up visit (up to approximately 4 weeks plus 30 days))
- Double-Blind Period: Number of Participants With Any Grade 3 or Higher TEAE(up to approximately 4 weeks plus 30 days)