Study of CM512 in Patients With Moderate-to-Severe Atopic Dermatitis

Launched by KEYMED BIOSCIENCES CO.LTD · Apr 25, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called CM512 for adults who have moderate to severe atopic dermatitis, a condition that causes itchy and inflamed skin. The study aims to find out how well CM512 works and whether it is safe for patients. It will involve adults aged 18 to 65 who have been diagnosed with atopic dermatitis for at least one year and meet specific criteria regarding the severity of their condition.

To participate, individuals should have significant skin involvement and experience regular itching. However, there are some reasons that might exclude someone from joining, such as recent treatments, other health issues that could affect the trial, or if they are pregnant. The trial is not yet recruiting participants, but once it starts, those who qualify can expect to be closely monitored throughout the study to assess their response to CM512.

Gender

ALL

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.