Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis

A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) When Used In Combination With Topical Corticosteroid Treatment (TCS) in Participants With Moderate to Severe Atopic Dermatitis.

This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of 611 when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.

Study Overview

• Status: Active, not recruiting
• Conditions: Dermatitis, Atopic; Eczema, Atopic
• Intervention / Treatment: Drug: Placebo; Drug: 611; Drug: Topical corticosteroid

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200050
      • Shanghai Dermatology Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 31003
      • Hangzhou First People's Hospital
    • Ningbo, Zhejiang, China, 315010
      • The first affiliated hospital of Ningbo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• Moderate to Severe Atopic Dermatitis.
• Recent history of inadequate response to treatment with topical medications.

Exclusion Criteria:

• Participation in a prior 611 clinical study.
• Treatment with the following prior to the baseline visit: 1) Systemic corticosteroid or Immunosuppressants / Immunomodulators within 4 weeks or within 5 half-lives (if known), whichever is longer. 2) Monoclonal antibody within 5 half-lives (if known) or 4 months, whichever is longer. 3) Cell-depleting within 6 months.
• Treatment with a live (attenuated) vaccine within 2 months of the baseline visit or planned during the study.
• Serious or Uncontrolled diseases that may affect the safety of participants during the study period or hinder their completion of the study.
• Evidence of active acute or chronic hepatitis.
• History of malignancy within 5 years before the screening visit or currently.
• Pregnant or breastfeeding women, or women planning to become pregnant.
• Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 611 interval 1+Topical Corticosteroid; Participants will receive 611 according to established dosing interval 1. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response.	Drug: 611; subcutaneous injection; Drug: Topical corticosteroid; Topical
Experimental: 611 interval 2+Topical Corticosteroid; Participants will receive 611 according to established dosing interval 2. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response.	Drug: 611; subcutaneous injection; Drug: Topical corticosteroid; Topical
Placebo Comparator: Placebo+Topical Corticosteroid; Participants will receive Placebo according to according to established dosing intervals. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response.	Drug: Placebo; subcutaneous injection; Drug: Topical corticosteroid; Topical

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants achieving EASI-75 (≥75% reduction from Baseline in EASI score)	Baseline to Week 16
Percentage of patients with an IGA score of 0 or 1 and a reduction ≥2-points from Baseline to Week 16.	Baseline to Week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16	Baseline to Week 16

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Estimated): October 12, 2025
• Study Completion (Estimated): August 16, 2026

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 12, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis
• Other Study ID Numbers: SSGJ-611-AD-III-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No