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Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

NCT04875169 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2023-06-01

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 330 subjects aged 12 to 75 years old with moderate to severe atopic dermatitis.

Conditions

Interventions

DRUG

Core Treatment Active Experimental: SHR0302 Dose#1

Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks

DRUG

Core Treatment Active Experimental: SHR0302 Dose#2

Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks

DRUG

Core Treatment Placebo Comparator: Placebo

Drug: Placebo Oral tablets taken once daily (QD) for 16 weeks

DRUG

Extension Treatment Active Experimental: SHR0302 Dose#1

Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks

DRUG

Extension Treatment Active Experimental: SHR0302 Dose#2

Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks

Sponsors & Collaborators

  • Reistone Biopharma Company Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2022-08-12
Completion
2023-05-23

Countries

  • Canada
  • China

Study Locations

More Related Trials

Entities

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 NCT04875169 on ClinicalTrials.gov