NCT04875169

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

A Randomized, Double Blind and Placebo Controlled Phase 3 Study to Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 336 (actual)
• Sponsor: Reistone Biopharma Company Limited · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study consists of a screening period followed by a placebo-controlled treatment period and then an extension treatment period and completed after a follow-up period after the completion of active treatment.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-04-30
• Primary completion: 2022-08-12
• Completion: 2023-05-23
• First posted: 2021-05-06
• Last updated: 2023-06-01

Locations

52 sites across 2 countries: Canada, China