Clinical Trials Directory

Trials / Unknown

UnknownNCT05470413

Evaluate the Efficacy and Safety of SHR0302 in Adult Patients With Severe Alopecia Areata

A Randomized, Double-Blinded, and Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of SHR0302 in Adult Patients With Severe Alopecia Areata

Status
Unknown
Phase
Phase 3
Study type
Interventional
Enrollment
330 (actual)
Sponsor
Reistone Biopharma Company Limited · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

This is a multi-central, double-blind, randomized, parallel, placebo-controlled phase 3 study in adult subjects with severe alopecia areata (SALT≥50%). Approximately 330 adult patients will be enrolled into the study. Efficacy and safety of two doses of SHR0302 will be compared to placebo.

Conditions

Interventions

TypeNameDescription
DRUGSHR0302SHR0302 4 mg
DRUGSHR0302SHR0302 8 mg
DRUGPlaceboPlacebo

Timeline

Start date
2022-04-18
Primary completion
2023-10-31
Completion
2024-02-15
First posted
2022-07-22
Last updated
2023-09-05

Locations

31 sites across 1 country: China

Source: ClinicalTrials.gov record NCT05470413. Inclusion in this directory is not an endorsement.