NCT04717310

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 645 (actual)
• Sponsor: Reistone Biopharma Company Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will evaluate the topical SHR0302 ointment, a JAK (Janus Kinase) inhibitor, in atopic dermatitis patients. The EASI (Eczema Area and Severity Index), IGA (immunoglobulin A), SCORAD (Scoring of Atopic Dermatitis),DLQI (Dermatology Life Quality Index)and NRS (Numeric Rating Score) will be applied to assesses to the efficacy, and other safety measurements will be also collected within the whole study duration.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2020-12-30
• Primary completion: 2023-09-08
• Completion: 2024-07-14
• First posted: 2021-01-22
• Last updated: 2023-09-05

Locations

31 sites across 1 country: China