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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Moderate-to-severe Atopic Dermatitis
• Intervention / Treatment: Drug: JYP0061 15 mg; Drug: JYP0061 30 mg; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Huashan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The age of the participants should be between 18 and 65 years old, with no restrictions on gender.
• Participants must weigh 40 kg or more
• At the time of screening, participants must meet the Williams criteria for atopic dermatitis, have had the condition for at least one year, and the severity of the disease should be moderate to severe;
• Participants agree from the time of signing the informed consent form until the completion of the study's final visit to use only non-medicated emollients (moisturizing creams) or other concomitant treatments allowed by the protocol.
• Fully understand the purpose and requirements of this trial, voluntarily participate, and sign the written informed consent form, and are able to complete the study according to its requirements.

Exclusion Criteria:

• Suspected or confirmed allergy to any component of the study drug or similar ingredients, or having a history of moderate allergic diseases (such as food allergies, drug allergies, etc., except for allergies related to atopic dermatitis) at the time of signing the informed consent form;
• At the time of screening, having other skin diseases or skin infections that could affect the evaluation of the trial results, or having extensive tattoos, birthmarks, skin scars, etc., in the area of skin lesions, aside from atopic dermatitis;
• Having or having had other connective tissue diseases, apart from a history of atopic dermatitis;
• Participation in another clinical trial within one month prior to screening or within five half-lives of the investigational drug (whichever is longer);
• Underwent major surgery within 12 weeks prior to screening;
• Conditions that negatively affect the immune response (such as history of organ transplantation), or subjects with known immunodeficiency syndromes (acquired immunodeficiency syndrome, genetic immunodeficiency, and drug-induced immunodeficiency).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JYP0061 15 mg Group; Participants in this arm will receive 15 mg of JYP0061 once daily for a total treatment period of 12 weeks.	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.
Experimental: JYP0061 30 mg Group; articipants in this arm will receive 30 mg of JYP0061 once daily for a total treatment period of 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.
Placebo Comparator: Placebo Group; Participants in this arm will receive a placebo once daily for a total treatment period of 12 weeks.	Drug: Placebo; Participants in the placebo group will receive a matching placebo tablet once daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from baseline.	The Eczema Area and Severity Index (EASI) is a measure of eczema severity, combining area coverage and symptom intensity (erythema, edema/papulation, excoriation, lichenification) for four body regions. EASI scores range from 0 (no eczema) to 72 (maximum severity), with higher scores indicating worse outcomes. This primary outcome assesses the proportion of participants who achieve at least a 75% reduction in EASI from baseline to Week 12.	Evaluations will be conducted weekly for up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving EASI 75 at Weeks 2, 4, and 8.	Percentage of participants achieving a 75% reduction in EASI from baseline at each specified week.	Weeks 2, 4, and 8.

Collaborators and Investigators

• Sponsor: Guangzhou JOYO Pharma Co., Ltd
• Collaborators: Chengdu JOYO pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2023
• Primary Completion (Estimated): February 10, 2026
• Study Completion (Estimated): October 10, 2026

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: atopic dermatitis
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: JYP0061M210

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No