NCT07682506招募中3 期
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of MH004 Ointment in Adolescent and Adult Subjects With Non-segmental Vitiligo
Minghui Pharmaceutical (Hangzhou) Ltd1 个研究点 分布在 1 个国家目标入组 405 人开始时间: 2026年8月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 405
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving at least a 75% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI75) at Week 24 (W24)
研究概览
简要总结
This is a randomized, double-blind, multicenter, placebo-controlled clinical study intended to evaluate the efficacy, safety and population pharmacokinetic profiles of MH004 ointment in eligible participants with NSV.
详细描述
The study consists of a screening period, a treatment period and a follow-up period, with the treatment period divided into two phases. In Double-blind Treatment Phase (24 weeks, D1 to W24), participants will be randomized at a 2:1 ratio to receive either MH004 ointment or placebo. And in Extended Treatment Phase (28 weeks, W25 to W52), after all participants complete all assessments prior to dosing at W24, they will enter the extended treatment phase and receive 1.0% MH004 ointment with the same dosing regimen as that in the double-blind treatment phase, administered twice daily (BID) until W52. Upon completion of study treatment, all participants will enter a 4-week safety follow-up period. The primary objective of this trial is the proportion of participants achieving at least a 75% improvement from baseline in the Facial Vitiligo Area Scoring Index at Week 24 (F-VASI75).
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)
盲法说明
Double-Masked
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 12 to 75 years inclusive at the time of signing the Informed Consent Form (ICF), with no restriction on gender.
- •Clinically diagnosed with non-segmental vitiligo.
- •Prior to study drug administration, participants with vitiligo shall meet the following criteria regarding vitiligo lesion area: Facial lesion area ≥ 0.3% body surface area (BSA), and Facial Vitiligo Area Scoring Index (F-VASI) score ≥ 0.
- •Agree to discontinue all vitiligo therapeutic medications and interventions from the time of ICF signature until the end of the last study visit. Over-the-counter (OTC) drugs shall not exert therapeutic effects on vitiligo or interfere with skin pigmentation, including corticosteroids and other immunomodulators. Final eligibility of such OTC drugs shall be determined by the Investigator. Camouflaging makeup is permitted.
- •Women of Childbearing Potential (WOCBP) and male participants whose partners are WOCBP must agree to use reliable contraceptive methods throughout the trial period and for 28 days after the last study drug administration (abstinence, prior sterilization, oral contraceptives, and/or barrier methods [condoms, diaphragms, cervical caps, etc.]). For WOCBP, the human chorionic gonadotropin (hCG) pregnancy test result at the screening visit and prior to the first drug administration at the baseline visit must be negative. Male participants shall not donate sperm during the trial and for 3 months after study completion or drug discontinuation.
- •The participant and/or their legal guardian shall fully understand the trial content, requirements and procedures, voluntarily participate in this clinical trial and sign the ICF, and be willing and able to comply with scheduled visits, treatment regimens, laboratory tests and other study procedures throughout the trial.
排除标准
- •All terminal hairs (i.e., beard, eyebrows, eyelashes) within facial vitiligo areas are depigmented white.
- •Other subtypes of vitiligo or hypopigmentary disorders
- •Segmental vitiligo, unclassified vitiligo, or mixed vitiligo;
- •Other differential diagnoses of vitiligo or other cutaneous hypopigmentary diseases (e.g., piebaldism, pityriasis alba, nevus anemicus, post-inflammatory hypopigmentation, chemical leukoderma, tinea versicolor, etc.).
- •Specific prior treatment history:
- •Prior use of any JAK inhibitor (systemic or topical) for vitiligo treatment at any time;
- •Prior depigmentation therapy for vitiligo (e.g., monobenzone), excluding hydroquinone;
- •Prior melanocyte-keratinocyte transplantation or other surgical procedures for vitiligo on the face.
- •Treatments administered within the required washout period
- •Use of biologic agents within 12 weeks or 5 half-lives (whichever is longer) prior to the first study drug administration;
- •Receipt of laser therapy or any form of phototherapy (including tanning beds) within 8 weeks prior to the first study drug administration;
- •Within 4 weeks prior to the first study drug administration:
- •Systemic immunomodulators (e.g., corticosteroids, methotrexate, cyclosporine, etc.); Systemic medications that may affect vitiligo (e.g., melanocyte-stimulating agents, tetracyclines, methoxsalen, etc.); Administration of live or live-attenuated vaccines;
- •Oral traditional Chinese medicines for vitiligo within 2 weeks prior to the first study drug administration;
- •Topical agents applied to vitiligo lesions within 1 week prior to the first study drug administration (e.g., corticosteroids, calcineurin inhibitors, PDE4 inhibitors, retinoids, vitamin D3 analogues, or topical Chinese herbal preparations);
- •Temporary tattoos within vitiligo lesions within 30 days before the first dose (excluding vinyl adhesive tattoos), or any permanent tattoos previously placed within vitiligo lesions.
- •Concomitant diseases or medical history that may interfere with the study
- •Specific risks of cardiovascular and thromboembolic events
- •Active or latent infections
- •Positive virology screening results at screening
- •History of malignancy
- •Clinically significant abnormal laboratory values
- •Subjects planning major invasive procedures during the study, or with prior or planned organ transplantation requiring long-term immunosuppressants (e.g., kidney or liver transplantation).
- •Planned administration of live or live-attenuated vaccines during the study period.
- •Female subjects who are pregnant or breastfeeding.
- •Participation in another interventional drug clinical trial within 3 months or at least 5 half-lives (whichever is longer) prior to randomization; or participation in a medical device clinical trial within 3 months prior to randomization.
- •Hypersensitivity and intolerance Known hypersensitivity to the investigational product or any excipient components.
- •Other exclusion factors
- •History of alcohol abuse or substance misuse;
- •Subjects shall avoid intentional excessive sun exposure during the study (e.g., prolonged sunbathing, sun exposure for tanning purposes);
- •Body mass index (BMI) < 16 kg/m² or > 40 kg/m², where BMI = weight (kg) / height² (m²);
- •Any other conditions deemed inappropriate for study participation by the Investigator.
研究组 & 干预措施
Double-Masked Period: MH004 1.0% Ointment
Experimental
Participants received MH004 1.0% Ointment topically twice a day (BID) from Day 1 to Week 24 during the Double-Masked Period.
干预措施: MH004 1.0% Ointment (Drug)
Double-Masked Period: MH004 Placebo
Placebo Comparator
Participants received MH004 Placebo Ointment topically twice a day (BID) from Day 1 to Week 24 during the Double-Masked Period.
干预措施: MH004 Placebo Ointment (Drug)
Extended Treatment Period: MH004 1.0% Ointment
Experimental
Participants received MH004 1.0%Ointment twice a day (BID) from Week 25 to Week 52 during the Extended Treatment Period.
干预措施: MH004 1.0% Ointment (Drug)
结局指标
主要结局
Proportion of participants achieving at least a 75% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI75) at Week 24 (W24)
时间窗: Baseline; Week 24
An F-VASI75 responder achieved at least 75% 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).
次要结局
- Proportion of participants achieving at least a 50% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI50) at Week 24 (W24)(Baseline; Week 24)
- Proportion of participants achieving at least a 90% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI90) at Week 24 (W24)(Baseline; Week 24)
- Percentage change from baseline in facial body surface area (F-BSA) score at Week 52 (W52)(Baseline; Week 52)
- Proportion of participants achieving at least a 50% improvement from baseline in Total Vitiligo Area Scoring Index (T-VASI50) at Week 24 (W24)(Baseline; Week 24)
- Proportion of participants achieving at least a 75% improvement from baseline in Total Vitiligo Area Scoring Index (T-VASI75) at Week 24 (W24)(Baseline; Week 24)
- Proportion of participants achieving at least a 90% improvement from baseline in Total Vitiligo Area Scoring Index (T-VASI90) at Week 24 (W24)(Baseline; Week 24)
- Proportion of participants achieving F-VASI75 at Week 52 (W52)(Baseline; Week 52)
- Proportion of participants achieving T-VASI75 at Week 52 (W52)(Basline; Week 52)
- Percentage change from baseline in F-VASI score at Week 24(Baseline; Week 24)
- Percentage change from baseline in F-VASI score at Week 52(Baseline; Week 52)
- Percentage change from baseline in T-VASI score at Week 24(Baseline; Week 24)
- Percentage change from baseline in T-VASI score at Week 52(Baseline; Week 52)
- Percentage change from baseline in facial body surface area (F-BSA) score at Week 24 (W24)(Baseline; Week 24)
- Percentage change from baseline in total body surface area (T-BSA) score at Week 24 (W24)(Baseline; Week 24)
- Proportion of participants achieving F-VASI50 at Week 52 (W52)(Baseline; Week 52)
- Proportion of participants achieving F-VASI90 at Week 52 (W52)(Baseline; Week 52)
- Proportion of participants achieving T-VASI50 at Week 52 (W52)(Basline; Week 52)
- Proportion of participants achieving T-VASI90 at Week 52 (W52)(Basline; Week 52)
- Percentage change from baseline in total body surface area (T-BSA) score at Week 52 (W52)(Baseline; Week 52)
- 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 56))
- 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 56))
研究者
研究点 (1)
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