NCT06170840

A Study of QY101 Ointment in Subjects With Plaque Psoriasis

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of QY101 Ointment in Patients With Plaque Psoriasis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the effectiveness of QY101 ointment in adult patients with plaque psoriasis (2-20% BSA).

Detailed description

Participants will be stratified and randomly assigned to trial groups two (Test group 1:0.3%; Test group 2:1.0%, 60 patients per group) or placebo group (40 patients) according to the ratio of 3:3:2 and BSA (BSA \< 10% or BSA ≥ 10%) . All groups will be receive with QY101 ointment or placebo, treatment for twice daily (BID) for 12 weeks; All subjects are required to take part in visit at 2, 4, 6, 8 and 12 weeks, they were followed up for efficacy assessment, safety examination and pharmacokinetics samples collection (with week 8 as the primary efficacy endpoint), and safety follow-up was administered 28 ± 7 days after the last dose via telephone .

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	QY101Placebo/QY101 ointment	External use for BID

Timeline

• Start date: 2023-05-17
• Primary completion: 2024-02-29
• Completion: 2024-04-30
• First posted: 2023-12-14
• Last updated: 2023-12-19

Locations

1 site across 1 country: China