CM512 for adults with moderate-to-severe atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial compares CM512 against placebo in adults with moderate-to-severe atopic dermatitis. Participants must have had AD for at least one year and meet objective severity thresholds (EASI ≥16, IGA ≥3, ≥10% BSA involvement and mean weekly pruritus NRS ≥4). Eligible patients will receive either CM512 or a matching placebo and be monitored for efficacy and safety outcomes during the treatment period. The trial is sponsored by Keymed Biosciences and conducted at Peking University People's Hospital in Beijing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with a diagnosis of AD for at least 1 year according to the American Academy of Dermatology's consensus criteria prior to the screening visit meeting all of the following criteria:
* EASI≥16 at Screening and Baseline visits;
* Investigator's Global Assessment (IGA) score of≥3 at Screening and Baseline visits;

  * 10% Body Surface Area (BSA) of AD involvement at Screening and Baseline visits;
* Mean of weekly Pruritus Numeric Rating Scale (NRS) severity score≥4 at Baseline;

Exclusion Criteria:

* Not enough washing-out period for previous therapy.
* Concurrent disease/status which may potentially affect the efficacy/safety judgement.
* Organ dysfunction.
* Pregnancy.
* Other.

Where it's running

• Peking University People's hospital
  Beijing, 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

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.