Phase II Clinical Trial of MH004 Ointment in Patients With Non-segmental Vitiligo
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving Facial Vitiligo Area Scoring Index 50(F-VASI50) at Week 24.
研究概览
简要总结
This is a multicenter, randomized, double-blind, vehicle-controlled phase II study of MH004 Ointment with a 28-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 vitiligo.
详细描述
This phase II 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 or Vehicle arms and treated for up to 24 weeks, followed by a 28-week open-label LTS treatment period with 1.0% MH004 Ointment. The primary objective of this trial is to evaluate the efficacy of MH004 Ointment in adolescent and adult participants with vitiligo.
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 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 12 to 65 years (inclusive) of either gender.
- •Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% BSA on the face and total body vitiligo area not exceeding 20% BSA.
- •Fully understand the trial content, voluntarily participate in the trial, and sign the ICF.
- •Must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation.
排除标准
- •Other dermatoses that may complicate the assessment of vitiligo.
- •Previous depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
- •Use of protocol-defined treatments within the indicated washout period before baseline.
- •Liver or renal damage.
- •Allergic to any component of the investigational drug.
- •Pregnant or lactating subjects. -
研究组 & 干预措施
VC Period: Vehicle Ointment QD
Participants received vehicle ointment QD from Day 1 to Week 24 during the VC Period.
干预措施: Vehicle Ointment (Drug)
VC Period: MH004 1.0% Ointment QD
Participants received MH004 1.0% Ointment once a day (QD) from Day 1 to Week 24 during the Vehicle Control (VC) 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 24 during the Vehicle Control (VC) Period.
干预措施: MH004 Ointment (Drug)
VC Period: Vehicle Ointment BID
Participants received vehicle ointment BID from Day 1 to Week 24 during the VC Period.
干预措施: Vehicle Ointment (Drug)
LTS Period: 1.0% MH004 Ointment QD
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied MH004 1.0% Ointment or Vehicle Ointment QD will apply MH004 1.0% Ointment QD from week 24 to week 52 during the LTS period.
干预措施: MH004 Ointment (Drug)
LTS Period: 1.0% MH004 Ointment BID
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied MH004 1.0% Ointment or Vehicle Ointment BID will apply MH004 1.0% Ointment BID from week 24 to week 52 during the LTS period.
干预措施: MH004 Ointment (Drug)
结局指标
主要结局
Proportion of participants achieving Facial Vitiligo Area Scoring Index 50(F-VASI50) at Week 24.
时间窗: Baseline; Week 24
An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area \[BSA\]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).
次要结局
- Percentage of Participants Achieving a ≥ 75% Improvement from Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24(Baseline; Week 24)
- Percentage of Participants Achieving a ≥ 50% Improvement from Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Week 24(Baseline; Week 24)
- Percentage of Participants Achieving a ≥ 75% Improvement from Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) Score at Week 24(Baseline; Week 24)
- Percentage Change from Baseline in Facial Body Surface Area (F-BSA) at Week 24(Baseline; Week 24)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(From the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52))
- Percentage Change from Baseline in F-VASI at Week 24(Baseline; Week 24)
- Percentage Change from Baseline in T-VASI at Week 52(Baseline; Week 52)
- Proportion of participants achieving Facial Vitiligo Area Scoring Index 50(F-VASI50) at Week 52.(Baseline; Week 52)
- Percentage of Participants Achieving a ≥ 50% Improvement from Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Week 52(Baseline; Week 52)
- Percentage Change From Baseline in T-BSA at Week 52(Baseline; Week 52)