NCT04435392

Jaktinib Hydrochloride Cream For Atopic Dermatitis

A Phase I/II Study Of The Efficacy,Safety and PharmacokineticsOf Jaktinib Hydrochloride Cream In Subjects With Mild To Moderate Atopic Dermatitis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Jaktinib Hydrochloride Cream	Subjects in each group were scheduled to give the drug for 8 weeks.
DRUG	Placebo	Placebo

Timeline

• Start date: 2020-10-14
• Primary completion: 2022-09-08
• Completion: 2022-09-08
• First posted: 2020-06-17
• Last updated: 2024-04-02

Locations

1 site across 1 country: China