Study of CM310 Injection in Subjects With Moderate-to-Severe Atopic Dermatitis
A Randomized, Double Blind, Parallel-controlled Phase 2 Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate-to-severe Atopic Dermatitis
1 other identifier
interventional
160
1 country
1
Brief Summary
This study is a multi-center, randomized, double-blind, parallel controlled phase 2 study, aimed at evaluating the efficacy and safety of CM310 in the treatment of patients with moderate-to-severe atopic dermatitis, and observing Pharmacokinetics characteristics, Pharmacodynamics effects and immunogenicity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2023
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2023
CompletedFirst Posted
Study publicly available on registry
February 8, 2023
CompletedStudy Start
First participant enrolled
March 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2024
CompletedOctober 15, 2024
January 1, 2023
1.4 years
January 27, 2023
October 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of subjects achieving EASI-75
Proportion of subjects achieving EASI-75 (≥75% reduction from baseline in Eczema Area and Severity Index score).
up to week 12
Study Arms (2)
Group A
EXPERIMENTALCM310, subcutaneous
Group B
EXPERIMENTALCM310, subcutaneous
Interventions
Eligibility Criteria
You may qualify if:
- Have the ability to understand the study and voluntarily sign a written ICF.
- Age ≥ 18 and ≤ 75 years old, male or female.
- The fertile subjects agreed to take effective contraceptive measures throughout the study period.
- The subjects can communicate well with the investigators and complete the follow-up according to the protocol.
You may not qualify if:
- Live vaccine or attenuated live vaccine has been vaccinated or planned to be vaccinated within 12 weeks before randomization.
- He received allergen-specific immunotherapy (desensitization therapy) within 6 months before randomization.
- Major surgery is planned during the study period.
- Previous history of atopic keratoconjunctivitis and corneal involvement.
- Other combined skin diseases that may affect the evaluation of the study.
- Confronting IL-4R α Monoclonal antibody or CM310/placebo drug or ingredient allergy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2023
First Posted
February 8, 2023
Study Start
March 10, 2023
Primary Completion
July 18, 2024
Study Completion
July 18, 2024
Last Updated
October 15, 2024
Record last verified: 2023-01