NCT04445363

A Study With Jaktinib Hydrochloride Cream Applied Topically to Subjects With Alopecia Areata

A Phase I/II Study Of The Efficacy,Safety and Pharmacokinetics Of Jaktinib Hydrochloride Cream In Subjects With Mild To Moderate Alopecia Areata

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 160 (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(phase I) and a dose extension part(phase II).

Detailed description

In phase I of this study, a multi-center, randomized, placebo parallel control design was adopted. Enrolled subjects were randomly assigned to the experimental group or the placebo group.A total of 40 subjects are expected to be enrolled in about 4 centers. In phase II of this study, a multi-center, randomized, double-blind parallel, placebo-controlled design was adopted. Enrolled subjects were randomly assigned to the experimental group or the placebo group.About 120 subjects are expected to be enrolled in about 10 centers.

Conditions

• Alopecia Areata(AA)

Interventions

Type	Name	Description
DRUG	Jaktinib hydrochloride cream	Jaktinib hydrochloride cream/placebo applied topically in the morning and in the evening, administered continuously for 24 weeks
DRUG	Placebo	Dose extension: Placebo

Timeline

• Start date: 2020-08-12
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2020-06-24
• Last updated: 2024-03-06

Locations

1 site across 1 country: China