Study of CM512 in Patients With Moderate-to-Severe Atopic Dermatitis
ConditionAtopic Dermatitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKeymed Biosciences Co.Ltd
About this trial
A Phase 2 study designed to evaluate the efficacy and safety of CM512 in adult patients with moderate-to-severe Atopic Dermatitis (AD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Not enough washing-out period for previous therapy.
Concurrent disease/status which may potentially affect the efficacy/safety judgement.
Organ dysfunction.
Pregnancy.
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo Comparator
DrugPlacebo subcutaneous injection
CM512
Biological/VaccineCM512 subcutaneous injection
Treatment groups
200 Participants
are divided into 5 treatment groupsGroup A: Group 1Placebo comparator 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3Experimental treatment 1 intervention
Group D: Group 4Experimental treatment 1 intervention
Group E: Group 5Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percent change from Baseline in Eczema Area and Severity Index (EASI) at 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.
Time frame
Baseline, Week 24Sponsors and contacts
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Source ClinicalTrials.gov