Recruiting

ZL-82 Tablets for Moderate to Severe Atopic Dermatitis

What is being tested

The high-dose group of ZL-82 tablets

+ The low-dose group of ZL-82 tablets

+ The placebo group

Drug

Who is being recruted

Dermatitis+8

+ Dermatitis, Atopic

+ Hypersensitivity

From 18 to 75 Years

+35 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: February 2026

See protocol details

Summary

Principal SponsorChengdu Zenitar Biomedical Technology Co., Ltd

Study ContactWang Fangmei

Last updated: February 5, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 3, 2026

Actual date on which the first participant was enrolled.

This clinical trial is focused on finding out if ZL-82 tablets can help adults with moderate to severe atopic dermatitis, a kind of skin condition that causes itchy and inflamed skin. The study is important because it aims to not only determine if ZL-82 can effectively reduce the severity of the condition, as measured by the Eczema Area and Severity Index (EASI), but also to assess the safety and side effects of the drug. This could potentially lead to a new treatment option for those who suffer from this challenging skin condition. Participants in the study will take either ZL-82 tablets or a placebo every day for 16 weeks. A placebo looks like the real medication but doesn't have any active ingredients. Every two weeks, participants will visit the hospital for check-ups to monitor their skin condition and any side effects. They will also keep track of their symptoms and how much their EASI score changes from the start of the study. This helps researchers evaluate how well the treatment works and understand its potential risks.

Official TitleA 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

NCT07193589

Principal SponsorChengdu Zenitar Biomedical Technology Co., Ltd

Study ContactWang Fangmei

Last updated: February 5, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

111 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DermatitisDermatitis, AtopicHypersensitivityHypersensitivity, ImmediateImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin Diseases, GeneticSkin and Connective Tissue DiseasesSkin Diseases, EczematousGenetic Diseases, Inborn

Criteria

6 inclusion criteria required to participate

Male or female individuals aged 18 years and above and 75 years and below (inclusive of the threshold value, based on the date of signing the ICF), with BMI >= 19 kg/m2.

Participants are fully informed of the purpose and requirements of this trial, and voluntarily sign the informed consent form.

According to the Hanifin & Rajka diagnostic criteria (>= 3 out of 4 main 4, >= 3 out of 23 secondary symptoms, see Appendix 1), diagnosed as AD by the investigators, and with a history of AD for >= 1 year before screening.

IGA score of 3 or 4; EASI score >= 16; Average peak pruritus NRS score >= 4 in the past week (Note: The NRS average value is the average of the maximum NRS score of pruritus intensity over 7 consecutive days before baseline, with a score range of 0-10 for each day. At least 4 days of scores are required for the calculation of the average score); BSA (body surface area) affected by AD >= 10% (BSA: body surface area, in this trial, BSA is based on the average human body surface area of 1.6 m2).

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29 exclusion criteria prevent from participating

Allergy to the test drug or any component thereof, or allergy or intolerance to other oral Janus kinase (JAK) inhibitors.

Exclude participants who have a history of alcohol abuse within the past 1 year (with weekly alcohol intake exceeding 21 units for men and 14 units per week for women (1 unit = 360 mL of beer; or 150 mL of wine; or 45 mL of liquor)) or a history of drug abuse.

Within 12 weeks before the first administration of the investigational drug: Intravenous immunoglobulin or plasma exchange therapy; Drugs known to have an impact on the cardiac conduction system (such as Class I or III anti-arrhythmic drugs); Other biologics except dupilumab.

Within 4 weeks before administration, those who have used long-acting anticoagulant drugs (such as warfarin, dabigatran, etc.) or those who need continuous anticoagulant drug treatment (except aspirin <= 100 mg/day).

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

West China Hospital Sichuan University

Chengdu, ChinaOpen West China Hospital Sichuan University in Google Maps

Recruiting

One Study Center