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Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Patients With Mild-to-Moderate Atopic Dermatitis

NCT04717310 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 645

Last updated 2023-09-05

No results posted yet for this study

Summary

This is a Randomized, Double-blind, Vehicle-Controlled, Seamless and Adaptive-designed Phase II/III Study to Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Adult Patients with Mild-to-Moderate Atopic Dermatitis.

It will consist of phase II and phase III parts, phase II will be a dose-ranging part and phase III will be a pivotal study part.

Conditions

Interventions

DRUG

SHR0302 Ointment

SHR0302 Ointment Twice a day (BID)

DRUG

SHR0302 Ointment

SHR0302 Ointment Twice a day (BID)

DRUG

SHR0302 Ointment

SHR0302 Ointment Twice a day (BID)

DRUG

Vehicle

Twice a day (BID)

Sponsors & Collaborators

  • Reistone Biopharma Company Limited

    lead INDUSTRY

Principal Investigators

  • Yanhong Cheng · Reistone Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-12-30
Primary Completion
2023-09-08
Completion
2024-07-14

Countries

  • 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 NCT04717310 on ClinicalTrials.gov