The Study of CM326 in Moderate-to-severe Atopic Dermatitis
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of CM326 Injection in the Treatment of Adult Patients With Moderate-to-severe Atopic Dermatitis
1 other identifier
interventional
240
1 country
1
Brief Summary
This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, tolerance, pharmacokinetics, pharmacodynamics, and immunogenicity of CM326 in moderate-severe atopic dermatitis subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2022
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
December 26, 2022
CompletedStudy Start
First participant enrolled
December 27, 2022
CompletedFirst Posted
Study publicly available on registry
January 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedJanuary 4, 2023
December 1, 2022
1 year
December 26, 2022
December 31, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at visit 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 ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
at week 16
Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and reduction from baseline of ≥2 points at Visit 16
IGA is a 5-point scale ranging from 0 (clear) to 4 (very severe)
at week 16
Study Arms (3)
Group A
EXPERIMENTALGroup A: CM326, subcutaneous (SC)
Group B
EXPERIMENTALGroup A: CM326, subcutaneous (SC)
Group C
PLACEBO COMPARATORGroup C: placebo, subcutaneous (SC)
Interventions
Eligibility Criteria
You may qualify if:
- With confirmed Atopic Dermatitis (AD) at the screening.
- Age ≥ 18 years and ≤ 75 years, male or female.
- Have the ability to understand the nature of the study and voluntarily sign the informed consent.
- Be able to communicate well with investigators and follow up protocol requirements.
You may not qualify if:
- Not enough washing-out period for previous therapy.
- Received allergen specific immunotherapy (desensitization) within 6 months prior to baseline.
- Major surgery is planned during the study period.
- Women who are pregnant or breastfeeding, or who plan to become pregnant during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's hospital
Beijing, China
Central Study Contacts
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
December 26, 2022
First Posted
January 4, 2023
Study Start
December 27, 2022
Primary Completion
December 30, 2023
Study Completion
December 30, 2024
Last Updated
January 4, 2023
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share