Clinical Trials Directory

Trials / Completed

CompletedNCT04162899

A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis

A Randomized, Double-Blind and Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SHR0302 in Adult Patients With Moderate to Severe Atopic Dermatitis

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
105 (actual)
Sponsor
Reistone Biopharma Company Limited · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

This proposed study is a randomized, double-blind, placebo-controlled, 3-arm parallel, multicenter phase II study, designed to explore the efficacy and safety of SHR0302 treatment for patients with moderate to severe atopic dermatitis. The study will be conducted over a 12-week treatment period. Two active doses of SHR0302 will be compared to placebo and improvement in atopic dermatitis will be assessed using the Investigator's Global Score (IGA)

Conditions

Interventions

TypeNameDescription
DRUGDrug: SHR0302The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).

Timeline

Start date
2019-11-06
Primary completion
2020-08-21
Completion
2020-08-31
First posted
2019-11-14
Last updated
2023-05-09
Results posted
2023-05-09

Locations

23 sites across 1 country: China

Source: ClinicalTrials.gov record NCT04162899. Inclusion in this directory is not an endorsement.