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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05676242
Other study ID # ZGJAK026
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 11, 2023
Est. completion date December 2024

Study information

Verified date March 2024
Source Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Contact Cong Zhang
Phone +86-0512-57018310
Email zhangc@zelgen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Jaktinib Hydrochloride Tablet
Orally administered, twice a day

Locations

Country Name City State
China 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

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 Number and percentage of subjects with treatment emergent adverse event (TEAE) Safety of the drug 36 weeks after the first dose
Primary Number and percentage of subjects with Serious Adverse Event (SAE) Safety of the drug 36 weeks after the first dose
Secondary The diachronic change in the proportion of subjects whose total Eczema area and severity index (EASI) score decreased by = 75% from baseline The proportion of subjects who reached EASI-75 36 weeks after the first dose
Secondary 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 The proportion of subjects who reached IGA 0/1 36 weeks after the first dose
Secondary The diachronic change in the proportion of subjects whose pruritus Numerical Rating Scale (NRS) score improved by = 4 points from baseline The proportion of subjects who reached NRS4 36 weeks after the first dose
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