Jaktinib Hydrochloride Cream For Atopic Dermatitis

Status Completed

Clinical Trial Summary

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

Clinical Trial 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 Jaktinib 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04435392
Study type	Interventional
Source	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	October 14, 2020
Completion date	September 8, 2022

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See also
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