NCT04539639

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

A Multi-center,Randomized,Double-blind,Placebo,Parallel-controlled Phase II Clinical Study of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.
DRUG	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.
DRUG	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.

Timeline

• Start date: 2020-12-02
• Primary completion: 2022-05-19
• Completion: 2022-05-19
• First posted: 2020-09-07
• Last updated: 2023-03-24

Locations

1 site across 1 country: China