NCT06158490

A Study to Evaluate JYP0061 Tablets in Patients With Moderate-to-severe Atopic Dermatitis

An Efficacy and Safety Study of JYP0061 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Guangzhou JOYO Pharma Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of JYP0061 in adult patients with moderate-to-severe atopic dermatitis. The main questions it aims to answer are: * The efficacy of JYP0061 in treating adult patients with moderate-to-severe atopic dermatitis. * The safety profile of JYP0061 when administered to adult patients with moderate-to-severe atopic dermatitis. Participants will: * Be treated with either a low-dose or high-dose of JYP0061. * Undergo efficacy and safety evaluations as stipulated in the trial protocol.

Detailed description

The goal of this clinical trial is to assess JYP0061 for efficacy and safety in adult patients with moderate-to-severe atopic dermatitis. The main objectives it aims to address are the determination of the drug's therapeutic effect and its safety profile in this patient population. Upon providing written informed consent after being briefed on the study details and potential risks, participants will enter a screening period of up to 4 weeks to confirm their eligibility. The main tasks for participants will include: * Being randomized to receive either a low-dose or high-dose of JYP0061. * Completing a treatment course of 12 weeks. * Undergoing efficacy and safety assessments as prescribed by the study's protocol. Following the treatment phase, all participants, whether they have completed the treatment course on schedule or have discontinued early, will be monitored for an additional 4 weeks to further evaluate safety post-treatment.

Conditions

• Moderate-to-severe Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	JYP0061 15 mg	Participants in the JYP0061 15 mg group will receive a 15 mg oral tablet of JYP0061 once daily for 12 weeks.
DRUG	JYP0061 30 mg	articipants in the JYP0061 30 mg group will receive a 30 mg oral tablet of JYP0061 once daily for 12 weeks.
DRUG	Placebo	Participants in the placebo group will receive a matching placebo tablet once daily for 12 weeks.

Timeline

• Start date: 2023-12-27
• Primary completion: 2026-02-10
• Completion: 2026-10-10
• First posted: 2023-12-06
• Last updated: 2025-03-20

Locations

1 site across 1 country: China