NCT07193589

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

A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study Evaluating the Efficacy and Safety of ZL-82 Tablets in Participants With Moderate to Severe Atopic Dermatitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 111 (estimated)
• Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Atopic Dermatitis

Interventions

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

Timeline

• Start date: 2026-02-03
• Primary completion: 2027-12-30
• Completion: 2028-06-30
• First posted: 2025-09-26
• Last updated: 2026-02-04

Locations

1 site across 1 country: China