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NCT06158490Enrolling by invitationPhase 2

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

Source: ClinicalTrials.gov · Last updated 20 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
120 (estimated)
First submitted
28 Nov 2023
Start date
Dec 2023
Primary completion date
Feb 2026
Lead sponsor
Guangzhou JOYO Pharma Co., Ltd
NCT number
NCT06158490

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 120
  • From Dec 2023 to the primary completion date, Feb 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • 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;
  • 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).

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Huashan Hospital, Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.