NCT04346316

A Phase II Study in Patients With Alopecia Areata

A Randomized, Double Blind and Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SHR0302 Tablets in Adult Patients With Alopecia Areata

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Reistone Biopharma Company Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a global Phase 2 study to evaluate the safety and effectiveness of an investigational study drug (called SHR0302) in adults with moderate to severe alopecia areata.

Detailed description

The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 3 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
DRUG	SHR0302	Oral tablets taken once daily (QD)

Timeline

• Start date: 2020-05-13
• Primary completion: 2021-06-10
• Completion: 2021-06-29
• First posted: 2020-04-15
• Last updated: 2021-07-16

Locations

34 sites across 3 countries: United States, Australia, China

Regulatory

• FDA-regulated drug study