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
Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
A Phase 2 study designed to evaluate the efficacy and safety of CM512 in adult patients with moderate-to-severe Atopic Dermatitis (AD).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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;
Locations
Other Locations
China
Peking University People's hospital
RECRUITING
Beijing
Contact Information
Primary
Qian Jia
qianjia@keymedbio.com
+86-028-88610620
Time Frame
Start Date: 2025-06-19
Estimated Completion Date: 2026-11-07
Participants
Target number of participants: 200
Treatments
Placebo_comparator: Group 1
Experimental: Group 2
Experimental: Group 3
Experimental: Group 4
Placebo_comparator: Group 5
Related Therapeutic Areas
Sponsors
Leads: Keymed Biosciences Co.Ltd