Status:
COMPLETED
A Phase 3 Study of MH004 Ointment in Patients With Mild to Moderate Atopic Dermatitis
Lead Sponsor:
Minghui Pharmaceutical (Hangzhou) Ltd
Conditions:
Atopic Dermatitis (AD)
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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 th...
Detailed Description
This phase III 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 Oint...
Eligibility Criteria
Inclusion
- 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. -
Exclusion
- 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. -
Key Trial Info
Start Date :
June 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2025
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT07185282
Start Date
June 10 2023
End Date
August 15 2025
Last Update
September 22 2025
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China