Long-term safety and efficacy of CM512 for atopic dermatitis
An Open-Label, Multicenter Study to Evaluate Long-Term Safety and Efficacy of CM512 in Atopic Dermatitis Patients.
This open-label follow-up will test whether continuing CM512 is safe and helps people with atopic dermatitis who finished a parent CM512 study.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 246 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Keymed Biosciences Co.Ltd Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07230483 on ClinicalTrials.gov |
What this trial studies
This is an open-label, multicenter extension in which people who completed a parent CM512 trial continue to receive CM512 and are followed over a longer period. Participants will attend regular clinic visits for safety checks, monitoring of adverse events, and clinical assessments of their skin and symptoms. The study enrolls only those who completed the week 18 visit in CM512-101102 or the end-of-study visit in CM512-100001. Data collected will focus on long-term tolerability and maintenance of any clinical benefit seen in the parent studies.
Who should consider this trial
Good fit: Ideal candidates are people with atopic dermatitis who completed the specified parent CM512 studies and can understand and sign informed consent.
Not a fit: People who did not complete the required parent CM512 visits, who lack the required washout from prior treatments, or who have other medical conditions making participation unsafe may not receive benefit from this extension.
Why it matters
Potential benefit: If successful, continuing CM512 could provide sustained symptom control with an acceptable long-term safety profile for people with atopic dermatitis.
How similar studies have performed: This extension follows parent CM512 trials, indicating earlier-phase results warranted continued follow-up, but long-term outcomes for CM512 remain to be established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have the ability to understand the study and voluntarily sign a written informed consent form (ICF). * Subjects who have completed the week 18 evaluation in the parent study CM512-101102 or the End of Study(EOS) visit in the parent study CM512-100001. Exclusion Criteria: * Not enough washing-out period for previous therapy. * Any other condition assessed by the investigator that makes participants unsuitable for participation in this study.
Where this trial is running
Beijing, Beijing Municipality
- Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jianzhong Zhang — Peking University People's Hospital
- Study coordinator: Qian Jia
- Email: qianjia@keymedbio.com
- Phone: +86-028-88610620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.