Jaktinib Hydrochloride Cream For Atopic Dermatitis

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    92
  • sponsor
    Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Updated on 9 December 2021

Summary

This study includes a dose escalation part and a dose extension part.

Description

In the dose-increasing part, a multicenter, dose-increasing, randomized, double-blind, placebo-parallel control design was adopted. Subjects were enrolled into different dose groups in sequence according to the inclusion sequence, and each group was scheduled to give the drug for 8 weeks.Subjects in each group were observed for 4 weeks after administration. When the number of 2 grade drug-related adverse events (cases) was less than 50%, subjects in the next group could be enrolled.Otherwise, IDMC will decide whether to continue the next set of tests.Subjects in each group were randomly assigned to receive either Jackatinib cream (6 cases) or placebo (2 cases) in a ratio of 3 to 1.A total of 32 subjects are expected to be enrolled in 6 centers.

The dose expansion was a multicenter, randomized, double-blind, placebo-parallel control design in which subjects were randomly assigned to 3 groups (1 placebo group and 2 experimental drugs group).It is estimated that a total of 60 subjects will be enrolled in about 15 centers. This part is divided into two stages.Stage 2 test (9 ~ 16 weeks) : Extension test.

Details
Condition Eczéma (Dermatite Atopique), Hand Dermatitis, Dermatitis, Dermatite Atopique, ATOPIC DERMATITIS, Eczema (Atopic Dermatitis - Pediatric), Eczema (Atopic Dermatitis), Eczema, Dermatitis, Atopic, Atopic Dermatitis
Treatment Placebo, Jaktinib Hydrochloride Cream
Clinical Study IdentifierNCT04435392
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd
Last Modified on9 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

~ 65 years old (including boundary value), gender is not limited
Have a clinical diagnosis of atopic dermatitis
Have a PGA(Physician's Global Assessment) score of 2 (mild) or 3 (moderate) at baseline
The total area of atopic dermatitis is about 10%~20% of the total area of the body surface at baseline

Exclusion Criteria

Evidence of certain skin conditions/infections at baseline
Have certain laboratory abnormalities at baseline
Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception
Other conditions that the investigators considered inappropriate to participate in the trial
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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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