A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of MH004 Ointment Followed by a 44-week Open-Label Long-Term Safety Extension Period in Adolescents and Adults With Mild to Moderate Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving Investigator's Global Assessment treatment success (IGA-TS) at Week 4.
研究概览
简要总结
This is a multicenter, randomized, double-blind, vehicle-controlled phase III study of MH004 Ointment with a 44-week open-label long-term safety extension period. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and primary efficacy of MH004 Ointment in adolescents and adults with mild to moderate atopic dermatitis.
详细描述
This phase III trial of MH004 Ointment comprises two periods: a vehicle control period and an open-label long-term safety extension period. Participants will be randomly aligned to the 1.0% MH004 Ointment BID or Vehicle BID arm and treated for up to 8 weeks, followed by a 44-week open-label LTS treatment period with 1.0% MH004 Ointment BID. The primary objective of this trial is to evaluate the efficacy of MH004 Ointment in adolescent and adult participants with mild to moderate atopic dermatitis (AD).
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
Double-blind
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents aged ≥ 12 to 17 years, inclusive, and men and women aged ≥18 years.
- •Clinical diagnosis of mild to moderate atopic dermatitis (AD) for at least 1 year prior to Day
- •Participants meet all the following atopic dermatitis criteria:
- •VC period: IGA 2 to 3, affected BSA 3% to 20% (excluding scalp) at the baseline visit.
- •LTS period: IGA 0 to 4, affected BSA 0% to 20% (excluding scalp) at Week
- •Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.
- •Participants who have at least one AD lesion not located on the hands, feet, or genitalia.
- •Willingness to avoid pregnancy or fathering of children. -
排除标准
- •Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
- •Concurrent conditions and history of other diseases:
- •Immunocompromised.
- •Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Baseline.
- •Active acute bacterial, fungal, or viral skin infection within 1 week before Baseline.
- •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 classical areas of involvement such as the face or the folds.
- •Other types of eczema.
- •Clinically significant cardiac disease; new cerebral infarction within 6 months from dosing; malignancies within 5 years from dosing; low hemoglobin; severe renal disease on dialysis; liver disease.
- •Systemic corticosteroids treated within 4 weeks before dosing; immunizations or sedating antihistamines treated within 4 weeks before dosing; other topical treatments for AD within 1 week before dosing.
- •Previously received Janus kinase (JAK) inhibitors, systemic or topical.
- •Ultraviolet light therapy or prolonged exposure to UV radiation within 2 weeks before dosing.
- •Liver function tests: AST or ALT ≥ 2 × ULN; alkaline phosphatase and/or bilirubin > 1.5 × ULN.
- •Pregnant or lactating participants, or those considering pregnancy.
- •Alcohol or drug abuse. -
研究组 & 干预措施
LTS Period: Vehicle Ointment to MH004 1.0% Ointment BID
Participants who applied vehicle ointment BID during the VC Period, were randomized to apply MH004 1.0% ointment topically BID from Week 8 to 52 during the LTS Period.
干预措施: Vehicle Ointment (Drug)
VC Period: Vehicle Ointment BID
Participants received vehicle ointment BID from Day 1 to Week 8 during the VC Period.
干预措施: Vehicle Ointment (Drug)
LTS Period: MH004 1.0% Ointment BID
Participants who applied MH004 1.0% ointment during VC Period, continued applying MH004 1.0% ointment BID from Week 8 to 52 during the LTS Period.
干预措施: MH004 Ointment (Drug)
VC Period: MH004 1.0% Ointment BID
Participants received MH004 1.0% Ointment twice daily (BID) from Day 1 to Week 8 during the Vehicle Control (VC) Period.
干预措施: MH004 Ointment (Drug)
结局指标
主要结局
Proportion of participants achieving Investigator's Global Assessment treatment success (IGA-TS) at Week 4.
时间窗: Baseline to week 4.
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.
Proportion of participants achieving EASI-75 at Week 4.
时间窗: Baseline to week 4.
EASI scoring system examines 4 areas of the body 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) for an average degree of severity of each sign in each region. The severity strata for the EASI 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. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.
次要结局
- Key Secondary Endpoints: Proportion of participants achieving IGA-TS at Week 8.(Baseline to week 8.)
- Key Secondary Endpoints: Proportion of participants achieving EASI-75 at Week 8.(Baseline to week 8.)
- Key Secondary Endpoints: Proportion of participants with a ≥ 4-point improvement in Itch Numerical Rating Scale (INRS) from baseline to Week 4.(From pre-dose to 4 weeks after the first dose.)
- Key Secondary Endpoints: Proportion of participants with a clinically meaningful (≥ 6-point) improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form-Sleep Disturbance (8b - 24-hour recall) score at Week 4(From pre-dose to 4 weeks after the first dose.)
- Key Secondary Endpoints: Proportion of participants with a clinically meaningful (≥ 6-point) improvement in the PROMIS Short Form - Sleep - Related Impairment (8a - 24-hour recall) score at Week 4.(From pre-dose to 4 weeks after the first dose.)
- Incidence, Frequency, Duration and Severity of Treatment-Emergent Adverse Event (TEAE)(From the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52))
- Incidence of Treatment-Emergent Serious Adverse Event (SAE) and Incidence of AEs resulting discontinue medication(From the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52))
- Characterization of Pharmacokinetics (Ctrough) of MH004 Ointment in Participants With Mild to Moderate Atopic Dermatitis at Week 2.4.8 during the VC period and Week 12, 24, 36, 52 during the LTS period.(Baseline, Week 2, 4, 8, 12, 24, 36, 52)
- Change From Baseline in DLQI/CDLQI at Week 2, 4, 8, 12, 24, 52(Baseline, Week 2, 4, 8, 12, 24, 52)