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

NCT06158490 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: JYP0061M210
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Moderate-to-severe Atopic Dermatitis

Keywords

atopic dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proportion of participants achieving EASI 75 at Weeks 2, 4, and 8.

  Weeks 2, 4, and 8.

Study Arms (3)

JYP0061 15 mg Group

EXPERIMENTAL

Participants in this arm will receive 15 mg of JYP0061 once daily for a total treatment period of 12 weeks.

Drug: JYP0061 15 mg

JYP0061 30 mg Group

EXPERIMENTAL

articipants in this arm will receive 30 mg of JYP0061 once daily for a total treatment period of 12 weeks.

Drug: JYP0061 30 mg

Placebo Group

PLACEBO COMPARATOR

Participants in this arm will receive a placebo once daily for a total treatment period of 12 weeks.

Drug: Placebo

Interventions

JYP0061 15 mg DRUG

Participants in the JYP0061 15 mg group will receive a 15 mg oral tablet of JYP0061 once daily for 12 weeks.

JYP0061 15 mg Group

JYP0061 30 mg DRUG

articipants in the JYP0061 30 mg group will receive a 30 mg oral tablet of JYP0061 once daily for 12 weeks.

JYP0061 30 mg Group

Placebo DRUG

Participants in the placebo group will receive a matching placebo tablet once daily for 12 weeks.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Guangzhou JOYO Pharma Co., Ltd: lead

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: December 27, 2023
• Primary Completion: February 10, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: March 20, 2025

Record last verified: 2024-11

Locations

CN (1)