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NCT Number: NCT05526222

A Phase III Study of Jaktinib in Adults 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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

139 People's Middle Road

Changsha, Hunan, 410008, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Jaktinib Hydrochloride Tablet

Drug

Orally administered, twice a day

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2022
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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