A Phase II Clinical Study Evaluating of ZL-82 Tablets in Atopic Dermatitis

Sponsor
Chengdu Zenitar Biomedical Technology Co., Ltd
Study ID
NCT07193589
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • The high-dose group of ZL-82 tablets — DRUG
    Participants will take the investigational drug orally for 16 weeks, 200mg each time , once a day.
  • The low-dose group of ZL-82 tablets — DRUG
    Participants will take the investigational drug orally for 16 weeks, 100mg each time, once a day.
  • The placebo group — DRUG
    The participants will take the investigational drug orally for 16 weeks, 2 tablets each time , once a day.

Study Details

This clinical trial aims to explore whether the drug ZL-82 tablets can be used to treat moderate to severe atopic dermatitis in adults, and to understand the safety and tolerability of the drug. The main questions that the trial intends to answer are: Can ZL-82 tablets alleviate the Eczema Area and Severity Index (EASI) score of patients? What physical problems will patients have after taking ZL-82 tablets? The researchers will compare ZL-82 tablets with placebo (a substance with a similar appearance but without drug components) to observe whether ZL-82 tablets can be used to treat moderate to severe atopic dermatitis. Participants need to take ZL-82 tablets or placebo every day for 16 weeks, and visit the hospital for a check-up every two weeks; record their own symptoms and the percentage change of EASI score relative to the baseline.

Key Dates

First listed
Sep 26, 2025
Start date
Feb 3, 2026
Status verified
Feb 2026
Primary completion
Dec 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
111 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: The high-dose group of ZL-82 tablets
  • Experimental: The low-dose group of ZL-82 tablets
  • Placebo Comparator: The placebo group

Primary Outcome Measure

Compare the percentage changes in Eczema Area And Severity Index (EASI) scores from baseline between the ZL-82 tablets dose group and the placebo group. [ Time Frame: At the 16th week ]

Central Contacts

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