Evaluation of 611 in Chinese Children With Moderate to Severe Atopic Dermatitis(AD)

NCT07767253 | Not Yet Recruiting Phase 3

• 1 other identifier: SSGJ-611-PED-AD-III-02
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 5

Brief Summary

This study is a 2-part (parts A and B) study.The primary objective of the study is to evaluate the efficacy of 611 in Chinese Children with moderate to severe atopic dermatitis (AD).

Conditions

Dermatitis, Atopic

Keywords

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (3)

• Part A: drug concentration.

  concentration of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) .

  Baseline, Week 24.

• Part B: Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 18.

  The EASI score is 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.

  Baseline, Week 18.

• Part B: 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 18.

  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.

  Baseline to Week 18.

Secondary Outcomes (15)

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

  Baseline, Week 24.

• Part A: Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at each efficacy evaluation visit point.

  Baseline, Week 24.

• Part A: 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 each efficacy evaluation visit point.

  Baseline to Week24.

• Part A: Number of Participants With EASI-50 (>=50% Improvement From Baseline).

  Baseline, Week 24.

• Part A: Number of Participants With EASI-90 (>=90% Improvement From Baseline).

  Baseline, Week 24.

Other Outcomes (2)

• Part B: drug concentration.

  Baseline to Week 60.

• Part B: Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies.

  Baseline to Week 60.

Study Arms (3)

Part A (Open-label PK study)

EXPERIMENTAL

Age cohort :≥2 years old to \<6 years old

Drug: 611

Part B (Double-blind confirmatory study) 611

EXPERIMENTAL

The results of part A will be used to guide the enrollment for participants aged ≥2 years to \<6 years with AD for part B.

Drug: 611

Part B (Double-blind confirmatory study) placebo

PLACEBO COMPARATOR

Drug: Matching placebo

Interventions

611 DRUG

Solution for injection, subcutaneous (SC)

Part A (Open-label PK study)

Matching placebo DRUG

Solution for injection, subcutaneous (SC)

Part B (Double-blind confirmatory study) placebo

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The participants and their legally acceptable representatives are able to understand and comply with the research procedures, agree to participate in the research, and sign the Informed Consent Form (ICF) ;
• When signing the informed consent form, the age should be ≥ 2 years old and \< 6 years old for part A, and ≥ 2 years old and \< 12 years old for part B. any gender, with body weight ≥ 15 kg at baseline;
• During the screening process, patients were diagnosed with atopic dermatitis (AD) according to the Hanifin - Rajka criteria, and their AD medical history was evaluated by researchers to be ≥ 6 months for participants aged ≥2 years to \<6 years, ≥ 3 months for participants aged ≥6 years to \<12 years;
• At the screening and baseline, the Eczema Area and Severity Index (EASI) score is ≥ 16 points;
• At the screening and baseline, the Investigator Global Assessment (IGA) score is ≥3 points;
• At the time of screening and baseline, the affected body surface area (BSA) by atopic dermatitis (AD) is ≥10%;
• At baseline, the weekly average score of Daily pruritus Numerical Rating Scale (NRS) is ≥ 4 points;
• Participants should have relevant medical records, other medical visit records, or other evidence within the previous year for researchers to evaluate. The participants have poor efficacy of topical drug treatment;
• Be willing to use a stable dose of emollient (moisturizer) on the affected areas of atopic dermatitis (AD) twice a day for at least 7 days before randomization and continue to use it throughout the study period;
• Participants with potential fertility (e.g., females who have experienced menarche or males who have had nocturnal emissions) must agree to avoid sexual activity or use highly effective contraceptive methods throughout the entire study period and for at least 3 months after the last dose of the medication;
• The participants (if applicable) and their legally acceptable representatives shall be able to understand and complete (either independently or with the assistance of a guardian) the research - related questionnaire filling.

You may not qualify if:

• Intolerance to TCS / TCI treatment or contraindications to TCS / TCI;
• Merge other skin comorbidities that may interfere with the research evaluation;
• Combined with active parasitic infections (such as helminths) or suspected parasitic infections ;
• Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC) ;
• Randomly select patients with any malignant tumor diagnosed within the past 5 years or currently having the disease;
• The participant had a severe infection requiring intravenous antibiotics and/or hospitalization within 4 weeks before randomization, or had an active infection requiring oral antibiotics within 2 weeks before randomization, and the investigator evaluated that there might be uncontrollable risks for the participant to participate in this study. Or with a skin infection that requires treatment with topical anti-infective agents within 1 week before randomization;
• A history of known or suspected immunosuppression, including a history of invasive opportunistic infections; or those who, although the infection has resolved, are considered by the investigator to be likely to have frequent recurrences;
• 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 safety of the participants during the study and/or prevent the participants from completing the study, including but not limited to cardiovascular, gastrointestinal, liver, kidney, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, and mental diseases;
• Participants who have received topical therapies for AD systemic traditional Chinese medicine for AD, systemic glucocorticoids, or other immunosuppressants / immunomodulators, any cell-depleting agents, monoclonal antibodies within a specified period prior to randomization.
• Received live vaccines or live attenuated vaccines within 4 weeks before randomization;
• Participants with abnormal laboratory parameters deemed ineligible for enrollment at the Investigator's discretion. ;
• At the screening, the test results are positive for hepatitis B, positive for hepatitis C virus antibody (HCVAb), positive for human immunodeficiency virus antibody (HIVAb), and positive for serum Treponema pallidum antibody (TPAb);
• Used any investigational drugs within 8 weeks or 5 half-lives (whichever is longer) before randomization;
• Had a history of alcohol or drug abuse within 6 months before randomization;

Sponsors & Collaborators

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

Study Sites (5)

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, 100045, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Dermatology Hospital, Southern Medical University

Guangzhou, Guangdong, 510091, China

Location

Hunan Children's Hospital

Changsha, Hunan, 410007, China

Location

Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, 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, Doctor

  Beijing Children's Hospital

  PRINCIPAL INVESTIGATOR

• ZiGang Xu, Doctor

  Beijing Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinghong Zhou, Master

CONTACT

+86 18911301578; zhouqinghong@3sbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part A: Open Label Part B: Masked, Randomized
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A: Single Arm Part B: Parallel Group

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 17, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)