Evaluation of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Adults With Moderate to Severe Atopic Dermatitis

NCT06173284 | Completed Phase 3

• 1 other identifier: SSGJ-611-AD-III-01
• Study Type: interventional
• Target: 519
• Locations: 1 country
• Sites: 4

Brief Summary

The primary objective of the study was to evaluate the efficacy of 611 in Chinese adults with moderate to severe atopic dermatitis.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 16

  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.

  Baseline, Week 16

• 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 16

  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，Week 16

Secondary Outcomes (14)

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

  Baseline to Week 60

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

  Baseline to Week 60

• 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

  Baseline to Week 60

• Percentage Change From Baseline in EASI Score

  Baseline to Week 60

• Change From Baseline in Percent Body Surface Area (BSA) of AD Involvement

  Baseline to Week 60

Study Arms (2)

611

EXPERIMENTAL

Induction treatment period : subcutaneous injection, 611 600mg (loading dose, week 0) + 300mg Q2W (from Week 2 to Week 14, 7 cycles) Maintenance treatment period : subcutaneous injection, 611 300mg Q2W or Q4W

Drug: 611

Placebo

PLACEBO COMPARATOR

Induction treatment period : subcutaneous injection, placebo Q2W (from Week 0 to Week 14, 7 cycles) Maintenance treatment period : subcutaneous injection, 611 600mg (loading dose, week 16) + 300mg Q2W or Q4W

Drug: Matching placebo

Interventions

611 DRUG

subcutaneous injection

611

Matching placebo DRUG

subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent.
• Male or female adults ages 18 to 75 years old when signing the informed consent.
• AD (according to Hanifin-Rajka Criteria) that had been present for at least 1 years before the screening visit.
• Eczema Area and Severity Index (EASI) score greater than or equal to (\>=) 16 at the screening and baseline visits.
• Investigator's Global Assessment (IGA) score \>=3 (on the 0 to 4 IGA scale, in which 3 was moderate and 4 was severe) at the screening and baseline visits.
• Participants with \>=10 percent (%) body surface area (BSA) of AD involvement at the screening and baseline visits.
• Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity \>=4.
• Recent history (within 12 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments were otherwise medically inadvisable (e.g., because of important side effects or safety risks).
• Have applied a stable dose of topical emollient (moisturizer) twice daily for at least the 7 consecutive days immediately before the baseline visit.
• Female subjects of reproductive age (and their male partners) and male subjects (and their female partners) must use highly effective contraception throughout the study period and for at least 3 months after the last dose. The subjects had no plans to pregnancy, donate sperm or donate egg during the whole study period and for at least 3 months after the last dose.

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, except completely treated in situ carcinoma of the cervix at least 1 year, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin at least 1 year.
• Active chronic or acute infection requiring treatment with systemic anti-infective therapy within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit.
• Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent infections, per investigator judgment.
• Active TB, 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 such as corticosteroids, topical calcineurin inhibitors, PDE inhibitors, or Janus kinase (JAK) inhibitors within 2 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 vaccinated with live (attenuated) vaccine within 2 months before baseline or planned during the study period;
• Have used any investigational drug/treatment within 12 weeks before baseline;
• Planned or anticipated major surgical procedure during the patient's participation in this study.

Sponsors & Collaborators

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

Study Sites (4)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi, 330200, China

Location

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

Hangzhou, Zhejiang, 310003, China

Location

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Jinhua, Zhejiang, 322000, 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 Design

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

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: January 22, 2024
• Primary Completion: September 26, 2025
• Study Completion: November 20, 2025
• Last Updated: January 15, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)