Clinical Study of Jaktinib in the Treatment of Patients With Moderate and Severe Atopic Dermatitis
NCT ID: NCT04539639
Last Updated: 2023-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
166 participants
INTERVENTIONAL
2020-12-02
2022-05-19
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Jaktinib 50mg Bid
Jaktinib 50mg Bid+ Placebo 50mg Bid+Placebo 75mg Bid
Jaktinib
In the morning: 1 tablet of 50mg and 75mg placebo, 1 tablet of 50mg Jaktinib; In the evening: 1 tablet of 50mg and 75mg placebo, 1 tablet of 50mg Jaktinib.
Jaktinib 75mg Bid
Jaktinib 75mg Bid+ Placebo 100mg Bid
Jaktinib
In the morning: 2 tablet of 50mg placebo, 1 tablet of 75mg Jaktinib; In the evening: 2 tablet of 50mg placebo, 1 tablet of 75mg Jaktinib.
Jaktinib 100mg Bid
Jaktinib 100mg Bid+ Placebo 75mg Bid
Jaktinib
In the morning: 1 tablet of 75mg placebo, 2 tablet of 50mg Jaktinib; In the evening: 1 tablet of 75mg placebo, 2 tablet of 50mg Jaktinib.
placebo
Placebo 100mg Bid+ Placebo 75mg Bid
placebo
In the morning: 2 tablet of 50mg placebo, 1 tablet of 75mg placebo;In the evening: 2 tablet of 50mg placebo, 1 tablet of 75mg placebo.
Interventions
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Jaktinib
In the morning: 1 tablet of 50mg and 75mg placebo, 1 tablet of 50mg Jaktinib; In the evening: 1 tablet of 50mg and 75mg placebo, 1 tablet of 50mg Jaktinib.
Jaktinib
In the morning: 2 tablet of 50mg placebo, 1 tablet of 75mg Jaktinib; In the evening: 2 tablet of 50mg placebo, 1 tablet of 75mg Jaktinib.
Jaktinib
In the morning: 1 tablet of 75mg placebo, 2 tablet of 50mg Jaktinib; In the evening: 1 tablet of 75mg placebo, 2 tablet of 50mg Jaktinib.
placebo
In the morning: 2 tablet of 50mg placebo, 1 tablet of 75mg placebo;In the evening: 2 tablet of 50mg placebo, 1 tablet of 75mg placebo.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Suzhou Zelgen Biopharmaceuticals Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Qianjin Lu
Role: PRINCIPAL_INVESTIGATOR
Central South University
Locations
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The second xiangya hospital of central south university
Changsha, Hunan, China
Countries
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Other Identifiers
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ZGJAK011
Identifier Type: -
Identifier Source: org_study_id
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