CM512 for adults with moderate-to-severe atopic dermatitis

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of CM512 in Patients With Moderate-to-Severe Atopic Dermatitis

This study will test whether CM512 helps adults with moderate-to-severe atopic dermatitis reduce itching and improve skin lesions compared with a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Keymed Biosciences Co.Ltd (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT06947980 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with atopic dermatitis for at least one year who meet objective severity criteria (EASI ≥16, IGA ≥3, ≥10% BSA affected, and mean weekly pruritus NRS ≥4), who are not pregnant and who have completed required washout periods and have no major organ dysfunction are ideal candidates.

Not a fit: Patients with mild disease, those who cannot complete required washout from prior therapies, pregnant individuals, or people with significant organ dysfunction or other conditions that affect safety or outcome assessment are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, CM512 could reduce skin inflammation and itch and improve overall disease severity for adults with moderate-to-severe atopic dermatitis.

How similar studies have performed: Other systemic treatments for moderate-to-severe atopic dermatitis, including biologics and JAK inhibitors, have shown clear benefits in this population, while CM512 itself is a novel candidate being tested in this setting.

Eligibility criteria

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 this trial is running

Beijing

• Peking University People's hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Jianzhong Zhang — Peking University People's Hospital
• Study coordinator: Qian Jia

Conditions Atopic Dermatitis