Clinical Study of Jaktinib in the Treatment of Patients With Moderate and Severe Atopic Dermatitis
- Registration Number
- NCT04539639
- Lead Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Jaktinib in participants with moderate to severe atopic dermatitis.
- Detailed Description
The study is divided into two stages, the first stage test (1-12 weeks): the main test; the second stage test (13-24 weeks): the extended test.
The main test：The trial set up 4 treatment groups, including 3 dose exploration groups, Jaktinib 50mg Bid, 75mg Bid, 100mg Bid group and 1 placebo control group.
The extended test：Subjects in the placebo group were randomly assigned to receive Jaktinib 50mg Bid, 75mg Bid, and 100mg Bid treatments at a ratio of 1:1:1 (randomized in a blinded state and completed by IWRS in the background), the main test group (50mg Bid, 75mg Bid, 100mg Bid group) subjects still maintain the original dose after 12 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 166
- Meet the Chinese diagnostic criteria for atopic dermatitis (Zhang's criteria) and be diagnosed as atopic dermatitis.
- Participants must have moderate to severe AD at screening and randomization.
- Participants must have inadequate response to topical medications within 6 months of screening.
- Agree to use emollients daily
- Received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4 weeks prior to randomization.
- Have received certain types of vaccinations.
- Participants who do not agree to use adequate contraception during the trial and within 4 weeks after the last dose.
- Any Participants whom the investigator deems inappropriate for participation in this clinical study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo Placebo 100mg Bid+ Placebo 75mg Bid Jaktinib 100mg Bid Jaktinib Jaktinib 100mg Bid+ Placebo 75mg Bid Jaktinib 75mg Bid Jaktinib Jaktinib 75mg Bid+ Placebo 100mg Bid Jaktinib 50mg Bid Jaktinib Jaktinib 50mg Bid+ Placebo 50mg Bid+Placebo 75mg Bid
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving at least a 50% Reduction in Eczema Area and Severity Index (EASI 50) from Baseline At Week 12 The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD)
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 with a ≥2 Point Improvement Treatment at 2,4,8,12,16,20,24 weeks The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Percentage of Participants Achieving IGA of 0 or 1. Treatment at 2,4,8,12,16,20,24 weeks The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Trial Locations
- Locations (1)
The second xiangya hospital of central south university
🇨🇳Changsha, Hunan, China