A Phase 3 Study of MH004 Ointment in Patients With Mild to Moderate Atopic Dermatitis

NCT07185282 | Completed Phase 3

• 1 other identifier: MH004-P-302
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis (AD)

Outcome Measures

Primary Outcomes (2)

• Proportion of participants achieving Investigator's Global Assessment treatment success (IGA-TS) at 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.

  Baseline to week 4.

• Proportion of participants achieving EASI-75 at 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.

  Baseline to week 4.

Secondary Outcomes (9)

• 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.

Study Arms (4)

VC Period: MH004 1.0% Ointment BID

EXPERIMENTAL

Participants received MH004 1.0% Ointment twice daily (BID) from Day 1 to Week 8 during the Vehicle Control (VC) Period.

Drug: MH004 Ointment

VC Period: Vehicle Ointment BID

PLACEBO COMPARATOR

Participants received vehicle ointment BID from Day 1 to Week 8 during the VC Period.

Drug: Vehicle Ointment

LTS Period: MH004 1.0% Ointment BID

EXPERIMENTAL

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.

Drug: MH004 Ointment

LTS Period: Vehicle Ointment to MH004 1.0% Ointment BID

PLACEBO COMPARATOR

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.

Drug: Vehicle Ointment

Interventions

MH004 Ointment DRUG

MH004 1% ointment applied topically to the affected area as a thin film twice daily.

LTS Period: MH004 1.0% Ointment BID; VC Period: MH004 1.0% Ointment BID

Vehicle Ointment DRUG

Matching vehicle ointment applied topically to the affected area as a thin film twice daily.

LTS Period: Vehicle Ointment to MH004 1.0% Ointment BID; VC Period: Vehicle Ointment BID

Eligibility Criteria

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

You may qualify if:

• 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 1.
• 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 8.
• 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. -

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Minghui Pharmaceutical (Hangzhou) Ltd: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 22, 2025
• Study Start: June 10, 2023
• Primary Completion: December 13, 2024
• Study Completion: August 15, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)