Evaluation of 611 in Chinese Children and Adolescents With Moderate to Severe Atopic Dermatitis

Phase 2Active Not RecruitingNCT06324812

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.124 enrolled

Overview

The primary objective of the study was to evaluate the safety and pharmacokinetic of 611 in Chinese children and adolescents with moderate to severe atopic dermatitis.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

124

Conditions

Dermatitis, Atopic

Interventions

Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611)DRUG

subcutaneous injection，611 450/600mg (loading dose) + 300mg once every 2 weeks/4 weeks

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects or their legal guardians must be able to understand and comply with the study procedures. and must participate voluntarily and sign the written informed consent. * When signing the informed consent form (ICF), Part 1: 12 years old ≤ age \< 18 years old, weight ≥ 30kg; Part 2: 6 years old ≤ age \< 12 years old, weight ≥ 15kg. * AD (according to Hanifin-Rajka Criteria) that had been present for at least 1 years before the screening visit. * (Investigator's Global Assessment) IGA ≥ 3 at screening and baseline visits. * (Eczema Area and Severity Index) EASI ≥16 at screening and baseline visits. * Participants with \>=10 percent (%) body surface area (BSA) of AD involvement at screening and baseline visits. * Baseline peak pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity ≥4. * With documented recent history (within 1 year before the baseline visit) of inadequate response to topical AD medication(s) or for whom topical treatments is medically inadvisable. * Willing apply a stable dose of topical emollient (moisturizer) twice daily for at least the 7 consecutive days immediately before the baseline visit and continue for the duration of the study. * Potentially fertile subjects (such as women who have had their first period or men who have had sperm implantation) must use highly effective contraception throughout the study period and for at least 3 months after the last dose. * Patient, either alone or with help of parents/legal guardians, as appropriate, must be able to understand and complete study-related questionnaires. Exclusion Criteria: * Presence of skin comorbidities that may interfere with study assessments. * Presence of active endoparasitic infections; or suspected endoparasitic. * Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC). * History of malignancy within 5 years before the baseline visit. * Participants who had a severe infection. * Known or suspected history of immunosuppression. * Active tuberculosis, unless that was well documented that the participants had adequately treated. * Any medical condition that, in the opinion of the investigator, is serious or unstable and may affect the subject's safety and/or prevent the subject from completing the study. * Treatment with topical drugs within 2 weeks before baseline; or systemic corticosteroids or immunosuppressive drugs within 4 weeks or 5 half-lives (whichever is longer) before baseline. * Have been vaccinated with live (attenuated) vaccine within 4 weeks before baseline. * The lab abnormalities at screening or baseline and not suitable for inclusion in the study judged by investigator. * Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening. * History of alcohol or drug abuse within 6 months before baseline. * History of hypersensitivity to 611 or their excipients. * Have been participated in other clinical trials and used any experimental drugs within 8 weeks before baseline. * Planned major surgical procedure during the patient's participation in this study. * Patient is female who is pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study. * Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.

Locations (1)

Beijing Children's Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.

The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations，electrocardiogram，laboratory tests and, etc.

Time frame: From baseline to week 24

Minimum concentration (Cmin)

Minimum concentration (Cmin) of 611

Time frame: From baseline to week 24

Secondary Outcomes

Number of Participants with Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline)

The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

Time frame: From baseline to week 24

Number of Participants with Investigator's Global Assessment (IGA) Score of "0" or "1" and Improvement From Baseline of Greater Than or Equal to (>=) 2 Points

The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.

Time frame: From baseline to week 24

Number of Participants with Eczema Area and Severity Index (EASI) - 50 Response (>= 50% Improvement in Score From Baseline)

Data from ClinicalTrials.gov

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