A Phase III Study of Jaktinib in Adults With Moderate and Severe Atopic Dermatitis

December 30, 2025 updated by: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study of Jaktinib Hydrochloride Tablets in the Treatment of Adult Patients With Moderate and Severe Atopic Dermatitis

A multicenter, randomized, double-blind, placebo-controlled phase III clinical study of jaktinib hydrochloride tablets in the treatment of adult patients with moderate and severe atopic dermatitis

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

443

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410008
        • 139 People's Middle Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have fully understood the test and voluntarily signed the informed consent;
  • When signing the informed consent form, the age of male or female subjects must be ≥ 18 years old;
  • The onset time of atopic dermatitis was at least 1 year at the time of screening, and the subjects met the Hanifin and Rajka criteria for atopic dermatitis at the time of screening;
  • For women with reproductive ability and all male subjects, during the trial period and within 6 months after the discontinuation of the trial drug, they must maintain abstinence or contraception, including but not limited to physical and drug contraception.
  • The subjects were able to communicate well and agreed to follow the study and follow-up procedures.

Exclusion Criteria:

  • The investigator considers that any subjects are not suitable to participate in the trial.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Jaktinib Hydrochloride Tablet
Orally administered, twice a day
Experimental: Jaktinib low dose
Low dose
Drug: Jaktinib Hydrochloride Tablet
Orally administered, twice a day
Experimental: Jaktinib high dose
High dose
Drug: Jaktinib Hydrochloride Tablet
Orally administered, twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficacy in the treatment of moderate and severe atopic dermatitis
Time Frame: 16 weeks
The proportion of subjects whose Eczema Area and Severity Index (EASI) total score decreased by ≥ 75% from baseline
16 weeks
The efficacy in the treatment of moderate and severe atopic dermatitis
Time Frame: 16 weeks
The proportion of subjects with a systemic Investigator's Global Assessment (IGA) score of 0 or 1 and a decrease of ≥ 2 points from baseline
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The abnormal laboratory values and/or adverse events in the treatment of moderate and severe atopic dermatitis
Time Frame: up to 1 year
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Investigators

  • Study Director: Jason Wu, Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

August 25, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZGJAK025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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