A Phase III Clinical Study to Evaluate the Efficacy and Safety of MH004 Ointment in Non-segmental Vitiligo

NCT07682506 | Not Yet Recruiting Phase 3

• 1 other identifier: MH004-P-303
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitiligo

Keywords

vitiligo, NSV, MH004

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving at least a 75% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI75) at Week 24 (W24)

  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).

  Baseline; Week 24

Secondary Outcomes (21)

• 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

• 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

Study Arms (3)

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.

Drug: MH004 1.0% Ointment

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.

Drug: MH004 Placebo Ointment

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.

Drug: MH004 1.0% Ointment

Interventions

MH004 1.0% Ointment DRUG

MH004 1% ointment applied topically to the affected area as a thin film twice a day (BID).

Double-Masked Period: MH004 1.0% Ointment; Extended Treatment Period: MH004 1.0% Ointment

MH004 Placebo Ointment DRUG

MH004 Placebo ointment applied topically to the affected area as a thin film twice a day (BID).

Double-Masked Period: MH004 Placebo

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥ 0.3.
• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Minghui Pharmaceutical (Hangzhou) Ltd: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Ointments

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

CMO/ Senior Vice President of R&D

CONTACT

+ 86 0571-86963293; jwshi@minghuipharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-Masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 6, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): February 23, 2028
• Study Completion (Estimated): October 4, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)