Study of CM512 in Patients With Moderate-to-Severe Atopic Dermatitis
Recruiting · NCT06947980 · Interventional (participants receive a specific treatment) · Lead sponsor: Keymed Biosciences Co.Ltd
View the official record on ClinicalTrials.gov →Interventions studied
CM512Placebo Comparator
What this trial is about
A Phase 2 study designed to evaluate the efficacy and safety of CM512 in adult patients with moderate-to-severe Atopic Dermatitis (AD).
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Peking University People's hospital - Beijing, China