Clinical Study of Jaktinib in the Treatment of Patients With Moderate and Severe Atopic Dermatitis

  • STATUS
    Recruiting
  • End date
    Dec 26, 2022
  • participants needed
    161
  • sponsor
    Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Updated on 26 January 2021

Summary

The purpose of this study is to evaluate the efficacy and safety of Jaktinib in participants with moderate to severe atopic dermatitis.

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 testThe 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 testSubjects 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.

Details
Condition Eczema, Eczema (Atopic Dermatitis - Pediatric), ATOPIC DERMATITIS, Eczema (Atopic Dermatitis), ATOPIC DERMATITIS, Dermatitis, Atopic, Dermatite Atopique, Eczéma (Dermatite Atopique), Dermatitis, Hand Dermatitis, Eczema (Atopic Dermatitis), Dermatitis, Atopic, Hand Dermatitis, Eczema (Atopic Dermatitis - Pediatric), Eczéma (Dermatite Atopique), Dermatite Atopique
Treatment Placebo, Jacketinib
Clinical Study IdentifierNCT04539639
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Step 1 Connect with a study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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