Phase II Clinical Trial of MH004 Ointment in Patients With Non-segmental Vitiligo

Minghui Pharmaceutical

Status and phase: Active, not recruiting; Phase 2

Conditions: Vitiligo

Treatments: Drug: Vehicle Ointment; Drug: MH004 Ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT07181187

MH004-E-201

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 156 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged 12 to 65 years (inclusive) of either gender.

2. 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.

3. Fully understand the trial content, voluntarily participate in the trial, and sign the ICF.

4. Must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation.

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Exclusion criteria

1. Other dermatoses that may complicate the assessment of vitiligo.
2. Previous depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
3. Use of protocol-defined treatments within the indicated washout period before baseline.
4. Liver or renal damage.
5. Allergic to any component of the investigational drug.
6. Pregnant or lactating subjects. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 6 patient groups, including a placebo group

VC Period: MH004 1.0% Ointment QD

Experimental group

Description:

Participants received MH004 1.0% Ointment once a day (QD) from Day 1 to Week 24 during the Vehicle Control (VC) Period.

Treatment:

Drug: MH004 Ointment

VC Period: MH004 1.0% Ointment BID

Experimental group

Description:

Participants received MH004 1.0% Ointment twice daily (BID) from Day 1 to Week 24 during the Vehicle Control (VC) Period.

Treatment:

Drug: MH004 Ointment

VC Period: Vehicle Ointment QD

Placebo Comparator group

Description:

Participants received vehicle ointment QD from Day 1 to Week 24 during the VC Period.

Treatment:

Drug: Vehicle Ointment

VC Period: Vehicle Ointment BID

Placebo Comparator group

Description:

Participants received vehicle ointment BID from Day 1 to Week 24 during the VC Period.

Treatment:

Drug: Vehicle Ointment

LTS Period: 1.0% MH004 Ointment QD

Experimental group

Description:

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.

Treatment:

Drug: MH004 Ointment

LTS Period: 1.0% MH004 Ointment BID

Experimental group

Description:

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.

Treatment:

Drug: MH004 Ointment