Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06947980 | NOT YET RECRUITING | Atopic Dermatitis

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

Keymed Biosciences Co.Ltd

Brief Summary:

A Phase 2 study designed to evaluate the efficacy and safety of CM512 in adult patients with moderate-to-severe Atopic Dermatitis (AD).

Condition or disease

Atopic Dermatitis

Intervention/treatment

Placebo Comparator

CM512

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-05-13
Estimated Primary Completion Date : 2026-03-18
Estimated Study Completion Date : 2026-07-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Patients with a diagnosis of moderate-to-severe 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.
Study of CM512 in Patients With Moderate-to-Severe Atopic Dermatitis

Location Details

NCT06947980

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China,

Peking University People's hospital

Beijing, China,