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

Phase 3

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: Jaktinib Hydrochloride Tablet

• Registration Number: NCT05526222
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-14
• Study First Submitted: 2022-08-25
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-12
• Primary Completion: 2025-06
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 438

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jaktinib low dose	Jaktinib Hydrochloride Tablet	Low dose
Placebo	Jaktinib Hydrochloride Tablet	Placebo
Jaktinib high dose	Jaktinib Hydrochloride Tablet	High dose

Primary Outcome Measures

Name	Time	Method
The efficacy in the treatment of moderate and severe atopic dermatitis	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 Outcome Measures

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

Trial Locations

Locations (1)

139 People's Middle Road; 🇨🇳 Changsha, Hunan, China