NCT05525715

A Study of QY201 Tablet in Subjects With Moderate to Severe Atopic Dermatitis

A Study of Phase Ⅰb/II to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of QY201 Tablet in Subjects With Moderate to Severe Atopic Dermatitis

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ib/II, randomized, double-blind, placebo-controlled, parallel, multicenter study of a certain phase to evaluate the efficacy, safety, and pharmacokinetic characteristics of QY201 tablet in subjects in moderate to severe atopic dermatitis

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	2mg QY201 tablets or 2mg QY201 placebo,BID	2mg QY201 tablets or 2mg QY201 placebo,BID
DRUG	5mg QY201 tablets or 5mg QY201 placebo,BID	5mg QY201 tablets or 5mg QY201 placebo,BID
DRUG	10mg QY201 tablets or 10mg QY201 placebo,QD	10mg QY201 tablets or 10mg QY201 placebo,QD
DRUG	10mg QY201 tablets or 10mg QY201 placebo,BID	10mg QY201 tablets or 10mg QY201 placebo,BID
DRUG	15mg QY201 tablets or 15mg QY201 placebo,BID	15mg QY201 tablets or 15mg QY201 placebo,BID
DRUG	20mg QY201 tablets or 20mg QY201 placebo,BID	20mg QY201 tablets or 20mg QY201 placebo,BID
DRUG	5mg QY201 tablets，BID	5mg QY201 tablets，BID
DRUG	10mg QY201 tablets，BID	10mg QY201 tablets，BID
DRUG	20mg QY201 tablets，BID	20mg QY201 tablets，BID
DRUG	QY201 placebo，BID	QY201placebo，BID

Timeline

• Start date: 2022-10-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-09-02
• Last updated: 2022-09-02