Atopic Dermatitis
Conditions
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).
Interventions
DRUGPlacebo Comparator
Placebo subcutaneous injection
BIOLOGICALCM512
CM512 subcutaneous injection
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 24 | Baseline, Week 24 | The EASI score is used to measure the severity and extent of AD and measured erythema, edema/papulation, excoriation and lichenification on 4 anatomic regions of the body: head and neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. |
Countries
China
Contacts
Primary ContactQian Jia
Outcome results
None listed