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

NCT05526222 | Active Not Recruiting Phase 3

• 1 other identifier: ZGJAK025
• Study Type: interventional
• Target: 443
• Locations: 1 country
• Sites: 1

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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• The efficacy in the treatment of moderate and severe atopic dermatitis

  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

  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 Outcomes (1)

• The abnormal laboratory values and/or adverse events in the treatment of moderate and severe atopic dermatitis

  up to 1 year

Study Arms (3)

Jaktinib low dose

EXPERIMENTAL

Low dose

Drug: Jaktinib Hydrochloride Tablet

Jaktinib high dose

EXPERIMENTAL

High dose

Drug: Jaktinib Hydrochloride Tablet

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Jaktinib Hydrochloride Tablet

Interventions

Jaktinib Hydrochloride Tablet DRUG

Orally administered, twice a day

Jaktinib high dose; Jaktinib low dose; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

139 People's Middle Road

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Study Officials

• Jason Wu

  Suzhou Zelgen Biopharmaceuticals Co.,Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: September 2, 2022
• Study Start: July 14, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)