Clinical trial NCT06158490: A Study to Evaluate JYP0061 Tablets in Patients With Moderate-to-severe Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Moderate-to-severe Atopic Dermatitis
Keywords: atopic dermatitis
Lead sponsor: Guangzhou JOYO Pharma Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-12-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Proportion of participants achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from baseline.
timeFrame: Evaluations will be conducted weekly for up to 12 weeks
Secondary outcomes:
measure: Proportion of participants achieving EASI 75 at Weeks 2, 4, and 8.
timeFrame: Weeks 2, 4, and 8.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
Study officials:
References: