CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 105 enrolled
Drug / intervention
Drug: SHR0302drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04162899
NCT04162899Phase 2Completed
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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

Reistone Biopharma Company Limited·interventional·Posted Nov 14, 2019·Updated May 9, 2023

In Brief

A Phase 2 clinical trial evaluating Drug: SHR0302 for Atopic Dermatitis. Completed, enrolled 105 participants across 23 sites.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedNov 14, 2019
Enrollment StartNov 6, 2019
Primary CompletionAug 21, 2020
Study CompletionAug 31, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.6 years ago

Interventions

Drug: SHR0302drug

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