Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Phase II Study Evaluating the Efficacy and Safety of ZL-82 Tablets in Adults With Moderate to Severe Atopic Dermatitis
Led by Chengdu Zenitar Biomedical Technology Co., Ltd · Updated on 2026-02-04
111
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of ZL-82 tablets to treat moderate to severe atopic dermatitis in adults aged 18 to 75 years. The study aims to understand whether ZL-82 tablets can improve the Eczema Area and Severity Index (EASI) scores and to assess the safety and tolerability of the drug. Participants will be compared to a placebo group to observe differences in treatment effects and physical outcomes. Participants are randomly assigned to one of three groups: a high-dose ZL-82 tablet group taking 200 mg once daily, a low-dose ZL-82 tablet group taking 100 mg once daily, and a placebo group taking two tablets once daily. The treatment period lasts for 16 weeks, during which participants will take their assigned tablets daily and have check-ups every two weeks. They will also record their symptoms and the percentage change in their EASI scores compared to baseline. During the study, participants will undergo frequent assessments including health checkups, vital signs, laboratory tests, and electrocardiograms at multiple time points from screening through day 141. Blood concentrations of ZL-82 will be monitored on several days. Researchers will evaluate changes in EASI scores, Investigator's Global Assessment (IGA), pruritus rating scales, body surface area affected by dermatitis, quality of life, and patient self-assessments to measure outcomes. Safety will be monitored throughout, with adverse events tracked up to 20 weeks after treatment begins.
CONDITIONS
Brief 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 BMI 6 19 kg/m2
- Voluntary informed consent given after understanding the trial purpose and requirements
- Diagnosed with atopic dermatitis by Hanifin & Rajka criteria and history of AD for at least 1 year
- Moderate to severe atopic dermatitis defined by IGA score 3 or 4, EASI score 6, pruritus NRS average 4, and affected body surface area 10%
- History of inadequate response or intolerance to local corticosteroids, calcineurin inhibitors, or phototherapy requiring systemic treatment
- Use of mild moisturizing cream twice daily at stable dose for at least 7 days before first dose and agreement to continue during study
You will not qualify if you...
- Allergy or intolerance to study drug components or oral Janus kinase (JAK) inhibitors
- Recent use of certain systemic or topical treatments for AD or participation in other clinical trials within specified time frames
- History of major diseases affecting multiple organ systems or recent major surgeries
- Pregnant or lactating women, or planning to donate eggs or sperm during study or shortly after
- History of malignant tumors (except certain skin cancers)
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- Abnormal blood pressure or severe sleep apnea affecting safety
- Abnormal ECG findings such as prolonged PR interval or QTc
- History of severe cardiovascular, neurological, or pulmonary diseases
- Active infections or recent use of antibiotics
- Recent live or attenuated vaccinations
- History or suspicion of active or latent tuberculosis unless treated
- Abnormal blood counts or liver function tests
- Moderate to severe kidney impairment
- History of alcohol or drug abuse
- Any condition judged unsuitable by investigators for study completion or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants take ZL-82 tablets orally once a day for 16 weeks, receiving either a high dose, low dose, or placebo to evaluate efficacy and safety for moderate to severe atopic dermatitis.
Visits at Day 1, 15, 29, 57, 85, 113, and 141 for assessments and drug administration
Duration - Up to 4 weeks
Participants are monitored for safety and adverse events for up to 4 weeks after treatment completion to assess ongoing effects and collect final data.
Visits as needed up to 20 weeks from randomization
Trial Site Locations
Total: 1 location
1
West China Hospital Sichuan University
Chengdu, Sichuan, China, 610200
Actively Recruiting
Research Team
W
Wang Fangmei
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here