Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis
NCT ID: NCT06554847
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2024-09-23
2026-08-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of 611 in Chinese Adolescents With Moderate to Severe Atopic Dermatitis
NCT07042126
Evaluation of 611 in Chinese Adults With Moderate to Severe Atopic Dermatitis
NCT05544591
Evaluation of 611 in Chinese Adult Patients With Moderate-to-Severe Atopic Dermatitis
NCT05641558
Evaluation of 611 in Chinese Children and Adolescents With Moderate to Severe Atopic Dermatitis
NCT06324812
A Study of Two Different Formulations of 611 in Healthy Adult Subjects in China
NCT07042113
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
611
subcutaneous injection
Topical corticosteroid
Topical
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.
611
subcutaneous injection
Topical corticosteroid
Topical
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.
Placebo
subcutaneous injection
Topical corticosteroid
Topical
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
611
subcutaneous injection
Placebo
subcutaneous injection
Topical corticosteroid
Topical
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SSGJ-611-AD-III-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.