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

Prior treatment

• Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
• 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.
• Alcohol or drug abuse. -

Other illness

• 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.

Lab values

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

Other

• Pregnant or lactating participants, or those considering pregnancy.

• 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. -