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611

Phase 3

Dermatitis, Atopic | Small molecule | Dermatology |Co-Diagnostics, Inc.|Last Updated: Jan 15, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment699
FDA Designations
No designations recorded
Clinical trial landscape

611 · 2 trials · 1 indication

Phase 3 2
NCT07042126Evaluation of 611 in Chinese Adolescents With Moderate to Severe Atopic DermatitisDermatitis, Atopic
RECRUITING180 Analytics
NCT06173284Evaluation of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Adults With Moderate to Severe Atopic DermatitisDermatitis, Atopic
COMPLETED519 Analytics
PHASE3RECRUITING
Evaluation of 611 in Chinese Adolescents With Moderate to Severe Atopic Dermatitis
Dermatitis, Atopic
NCT07042126180
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PHASE3COMPLETED
Evaluation of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Adults With Moderate to Severe Atopic Dermatitis
Dermatitis, Atopic
NCT06173284519
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Study Endpoints
Primary Endpoints
Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 16
Baseline, 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

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
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

Secondary Endpoints
Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at each efficacy evaluation visit point except for Week 16
Baseline, Week 60
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 except for Week 16
Baseline to Week 60
Number of Participants With EASI-50 (>=50% Improvement From Baseline)
Baseline to Week 60
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
611EXPERIMENTAL -
placeboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
611DRUGDouble blind treatment period : 611 600 mg/450 mg at day 1，then 300 mg subcutaneous injection Q2W thereafter until week 16 Maintenance treatment period : 611 300 mg subcutaneous injection Q2W/Q3W until week 52.（The subjects in the placebo group during the double-blind treatment period need to be given a loading dose at week 16.）
Matching placeboDRUGDouble blind treatment period : placebo subcutaneous injection Q2W until week 16.
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Eligibility Criteria
Age Range12 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * The subjects and their legal guardians 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 ≥ 12 years old and \< 18 years old...

Countries:China
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Recent Changes (Last 90 Days)
LOWJul 5, 2026NCT07042126primaryCompletionDate: changed
LOWJul 5, 2026NCT07042126primaryCompletionDate: changed
LOWJul 5, 2026NCT07042126primaryCompletionDate: changed
LOWMay 24, 2026NCT07042126studyFirstPostDate: changed