Long-term safety and efficacy of CM512 for atopic dermatitis
Official title: An Open-Label, Multicenter Study to Evaluate Long-Term Safety and Efficacy of CM512 in Atopic Dermatitis Patients.
Run by Keymed Biosciences Co.Ltd · NCT07230483 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 246 (estimated) |
| Sponsor | Keymed Biosciences Co.Ltd Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | December 2025 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | November 17, 2025 |
| Trial ID | NCT07230483 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with atopic dermatitis who completed the specified parent CM512 studies and can understand and sign informed consent.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: This extension follows parent CM512 trials, indicating earlier-phase results warranted continued follow-up, but long-term outcomes for CM512 remain to be established.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.