A Phase III Extended Clinical Trial of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis

Phase 3

Recruiting

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

• Registration Number: NCT05676242
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary

To observe the safety and effectiveness of long-term use of jaktinib hydrochloride tablets in the treatment of moderate and severe atopic dermatitis

Detailed Description

If the enrolled subjects received the treatment of jaktinib hydrochloride tablets in the ZGJAK025 trial, they will continue to use the drug at the original dosage; If the enrolled subjects received placebo treatment in the ZGJAK025 trial, they will receive 100mg BID of jaktinib hydrochloride tablets, 75mg BID of jaktinib hydrochloride tablets or placebo at a ratio of 1:1:1 at random, and continue to take the drug on an empty stomach, with the longest continuous treatment not exceeding 36 weeks.

Study Timeline

• Study First Submitted: 2022-12-30
• Study First Submitted QC: 2023-01-06
• Study First Posted: 2023-01-09
• Study Start: 2023-01-11
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• The investigator thinks that the subject can continue to benefit from participating in the extension trial;
• Fully understand the extension trial and sign the informed consent form;
• Complete the ZGJAK025 trial for 16 weeks and have good compliance;
• It is expected that the time interval between the first administration and the last administration of ZGJAK025 trial for the subject should be ≤ 4 weeks;

Exclusion Criteria

• Within 4 weeks before enrollment, there were any adverse events ≥ 3 levels related to the test drug that did not return to level 1 or normal;
• The investigator thinks that the subject is not suitable for the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jaktinib 100mg BID	Jaktinib Hydrochloride Tablet	Drug: Jaktinib Hydrochloride Tablet 100mg dosage, orally administered, twice a day
Jaktinib 75mg BID	Jaktinib Hydrochloride Tablet	Drug: Jaktinib Hydrochloride Tablet 75mg dosage, orally administered, twice a day
Placebo	Jaktinib Hydrochloride Tablet	Drug: Placebo Orally administered, twice a day

Primary Outcome Measures

Name	Time	Method
Number and percentage of subjects with Serious Adverse Event (SAE)	36 weeks after the first dose	Safety of the drug
Number and percentage of subjects with treatment emergent adverse event (TEAE)	36 weeks after the first dose	Safety of the drug

Secondary Outcome Measures

Name	Time	Method
The diachronic change in the proportion of subjects whose total Eczema area and severity index （EASI） score decreased by ≥ 75% from baseline	36 weeks after the first dose	The proportion of subjects who reached EASI-75
The diachronic change of the proportion of subjects whose systemic Investigator's Global Assessment （IGA） score reached 0 or 1 and decreased by ≥ 2 points from baseline	36 weeks after the first dose	The proportion of subjects who reached IGA 0/1
The diachronic change in the proportion of subjects whose pruritus Numerical Rating Scale （NRS） score improved by ≥ 4 points from baseline	36 weeks after the first dose	The proportion of subjects who reached NRS4

Trial Locations

Locations (2)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College; 🇨🇳 Nanjin, Jiangsu, China