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

NCT06324812 | Active Not Recruiting Phase 1

• 1 other identifier: SSGJ-611-PED-AD-Ib/II-01
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (2)

• 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.

  From baseline to week 24

• Minimum concentration (Cmin)

  Minimum concentration (Cmin) of 611

  From baseline to week 24

Secondary Outcomes (10)

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

  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

  From baseline to week 24

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

  From baseline to week 24

• Number of Participants with Eczema Area and Severity Index (EASI) - 90 Response (>= 90% Improvement in Score From Baseline)

  From baseline to week 24

• Number of Participants Who Achieved >=4 Points/ >=3 Points With Improvement From Baseline in Weekly Average of Pruritus Numerical Rating Scale (NRS) Score From Baseline

  From baseline to week 24

Study Arms (1)

611

EXPERIMENTAL

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

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

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

611

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (1)

Beijing Children's Hospital

Beijing, Beijing Municipality, 100003, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

entacapone

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 Officials

• Lin Ma, MD

  Beijing Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 22, 2024
• Study Start: July 10, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)