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

Minghui Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis (AD)

Treatments: Drug: MH004 Ointment; Drug: Vehicle Ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT07185282

MH004-P-302

Details and patient eligibility

About

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.

Full 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 Ointment BID or Vehicle BID arm and treated for up to 8 weeks, followed by a 44-week open-label LTS treatment period with 1.0% MH004 Ointment BID. The primary objective of this trial is to evaluate the efficacy of MH004 Ointment in adolescent and adult participants with mild to moderate atopic dermatitis (AD).

Enrollment: 375 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adolescents aged ≥ 12 to 17 years, inclusive, and men and women aged ≥18 years.

2. Clinical diagnosis of mild to moderate atopic dermatitis (AD) for at least 1 year prior to Day 1.

3. 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.

4. Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.

5. Participants who have at least one AD lesion not located on the hands, feet, or genitalia.

6. Willingness to avoid pregnancy or fathering of children. -

Exclusion criteria

1. Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.

2. 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.

3. 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.

4. 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.

5. Previously received Janus kinase (JAK) inhibitors, systemic or topical.

6. Ultraviolet light therapy or prolonged exposure to UV radiation within 2 weeks before dosing.

7. Liver function tests: AST or ALT ≥ 2 × ULN; alkaline phosphatase and/or bilirubin > 1.5 × ULN.

8. Pregnant or lactating participants, or those considering pregnancy.

9. Alcohol or drug abuse. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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375 participants in 4 patient groups, including a placebo group

VC Period: MH004 1.0% Ointment BID

Experimental group

Description:

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

Treatment:

Drug: MH004 Ointment

VC Period: Vehicle Ointment BID

Placebo Comparator group

Description:

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

Treatment:

Drug: Vehicle Ointment

LTS Period: MH004 1.0% Ointment BID

Experimental group

Description:

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.

Treatment:

Drug: MH004 Ointment

LTS Period: Vehicle Ointment to MH004 1.0% Ointment BID

Placebo Comparator group

Description:

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.

Treatment:

Drug: Vehicle Ointment