Actively Recruiting
An Open-Label, Multicenter Study to Evaluate Long-Term Safety and Efficacy of CM512 in Patients with Atopic Dermatitis
Led by Keymed Biosciences Co.Ltd · Updated on 2025-11-17
246
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the long-term safety and effectiveness of CM512 in adults with atopic dermatitis who have previously completed treatment in a parent CM512 study. The study is open-label and conducted at multiple centers, focusing on patients with this skin condition to gather extended data on the investigational treatment. Participants will receive CM512 through subcutaneous injection during the study. The design includes multiple experimental groups, and the study period spans up to 52 weeks, allowing researchers to observe long-term effects after prior treatments in earlier studies. This phase 2 study does not use blinding, and participants are randomized among the groups. During the study, participants will be monitored for adverse events and other safety measures for up to one year. Researchers will collect data on the treatment's impact and any side effects, ensuring thorough evaluation. Participants must have completed earlier parts of the CM512 parent studies to join, and they will be followed closely throughout the study duration which ends in December 2027.
CONDITIONS
Brief Title
A Long-term Safety and Efficacy Study Evaluating CM512 in Atopic Dermatitis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand the study and voluntarily sign a written informed consent form
- Completed the week 18 evaluation in the parent CM512-101102 study or the End of Study visit in the parent CM512-100001 study
You will not qualify if you...
- Insufficient washout period from previous therapy
- Any other condition assessed by the investigator that makes the participant unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 52 weeks
Participants receive CM512 subcutaneous injections as part of the study treatment for atopic dermatitis.
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
Q
Qian Jia
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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