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611

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment519
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06173284Evaluation of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Adults With Moderate to Severe Atopic DermatitisPHASE3 COMPLETED 519 — — Jan 22, 2024Nov 20, 2025Jan 15, 20264 China
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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，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 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
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
611EXPERIMENTALInduction 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
PlaceboPLACEBO_COMPARATORInduction 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
Interventions
NameTypeDescription
611DRUGsubcutaneous injection
Matching placeboDRUGsubcutaneous injection
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent. 2. Male or female adults ages 18 to 75 years old when signing the informed consent. 3. AD (according to Hanifin-Rajka Crit...

Countries:China
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