Actively Recruiting
A Phase II Clinical Study Evaluating of ZL-82 Tablets in Atopic Dermatitis
Led by Chengdu Zenitar Biomedical Technology Co., Ltd · Updated on 2026-02-04
111
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase II Clinical Study Evaluating of ZL-82 Tablets in Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years, with a BMI of 19 kg/m2 or higher
- Voluntarily signed informed consent after understanding the trial
- Diagnosed with atopic dermatitis by Hanifin & Rajka criteria with a history of at least 1 year
- Moderate to severe atopic dermatitis defined by: IGA score 3 or 4, EASI score 16 or higher, average peak pruritus NRS score 4 or higher in past week, and body surface area affected by AD 10% or more
- History of inadequate response, no response, or intolerance to local corticosteroids, calcineurin inhibitors, or phototherapy within past 6 months, requiring systemic treatment
- Use of mild moisturizing cream twice daily for at least 7 days before treatment and agree to continue during the study
You will not qualify if you...
- Allergy to ZL-82 tablet components or other oral JAK inhibitors
- Use of oral JAK inhibitors, systemic biologics affecting AD, or certain topical and systemic AD treatments within specified times before baseline
- History of major diseases affecting multiple body systems or conditions that may affect trial results
- Pregnancy, lactation, or plans to donate eggs or sperm during or shortly after the study
- History of malignant tumors except certain skin cancers
- Recent major surgery or planned surgery during screening
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis (except negative RPR/TRUST)
- Abnormal blood pressure or heart conditions including specific ECG abnormalities
- History of severe cardiovascular or cerebrovascular diseases
- History of certain heart rhythm disorders or uncontrolled diabetes
- Other active skin diseases or significant neurological dysfunction
- History of immunodeficiency, herpes infections, or serious pulmonary diseases
- Recent use of intravenous antibiotics or oral antibiotics for infections
- Recent live or attenuated vaccines or active tuberculosis infection
- Abnormal blood test results outside defined limits
- Moderate to severe renal impairment
- History of alcohol or drug abuse within past year
- Use of certain cardiac, anticoagulant, or antiplatelet drugs within defined timeframes
- Recent significant blood loss or planned blood donation
- Any other condition the investigator considers unsuitable
AI-Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital Sichuan University
Chengdu, Sichuan, China, 610200
Actively Recruiting
Research Team
W
Wang Fangmei
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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