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

Atopic Dermatitis Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05526222
• Other study ID #: ZGJAK025
• Status: Recruiting
• Phase: Phase 3
• Start date: July 14, 2022
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: Cong Zhang
• Phone: +86-0512-57018308
• Email: zhangc[@]zelgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 438
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Jaktinib Hydrochloride Tablet
Orally administered, twice a day

Locations

Country	Name	City	State
China	139 People's Middle Road	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

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