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

NCT05470413 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2023-09-05

No results posted yet for this study

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

DRUG

SHR0302

SHR0302 4 mg

DRUG

SHR0302

SHR0302 8 mg

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Reistone Biopharma Company Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-18
Primary Completion
2023-10-31
Completion
2024-02-15

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05470413 on ClinicalTrials.gov