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

Last updated: March 22, 2023
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Overall Status: Completed

Phase

2

Condition

Atopic Dermatitis

Rash

Dermatitis, Atopic

Treatment

N/A

Clinical Study ID

NCT04539639
ZGJAK011
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meet the Chinese diagnostic criteria for atopic dermatitis (Zhang's criteria) and bediagnosed 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 ofscreening.
  • Agree to use emollients daily

Exclusion

Exclusion Criteria:

  • Received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4 weeksprior to randomization.
  • Have received certain types of vaccinations.
  • Participants who do not agree to use adequate contraception during the trial andwithin 4 weeks after the last dose.
  • Any Participants whom the investigator deems inappropriate for participation in thisclinical study

Study Design

Total Participants: 166
Study Start date:
December 02, 2020
Estimated Completion Date:
May 19, 2022

Study 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.

Connect with a study center

  • The second xiangya hospital of central south university

    Changsha, Hunan 410011
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.