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

August 31, 2026 updated by: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

417

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Baseline to Week 16
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.
Time Frame: 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
Time Frame: Baseline to Week 16
Baseline to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2024

Primary Completion (Actual)

October 20, 2025

Study Completion (Actual)

August 19, 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)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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