A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of CMS-D001 in Adult Patients With Moderate to Severe Atopic Dermatitis
Sponsored by Dermavon Holdings Limited
About this trial
Last updated 3 months ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Started 2 months ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
* Aged 18-75 years, willing to sign the ICF
* Clinical diagnosis of AD (Hanifin & Rajka criteria) for ≥1 year
* At screening and baseline, EASI score ≥ 16 points, IGA ≥ 3, BSA ≥ 10%, Itch NRS ≥ 4
* Documented history of inadequate response to topical corticosteroids (TCS) or -topical calcineurin inhibitors (TCI).
* Subject has applied a topical emollient (moisturizer) daily for at least 7 days prior to the Baseline Visit.
Exclusion Criteria
* Other active skin conditions that may interfere with AD assessment.
* History of a serious bacterial, fungal, or viral infection requiring hospitalization or intravenous antimicrobial therapy within 3 months prior to the first dose.
* History of a bacterial, fungal, or viral infection requiring oral antimicrobial therapy within 4 weeks prior to the first dose.
* Active infection or acute illness within 7 days prior to the first dose.
* Chronic or recurrent infectious diseases at screening or baseline that may increase safety risks.
* Evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.
* History of a major or unstable clinical condition within 6 months prior to the first dose, which would compromise participation.
* History of malignant tumour within 5 years before screening.
* Previous or current autoimmune diseases.
* Positive results of confirmatory test for hepatitis B, hepatitis C, human
* immunodeficiency virus (HIV) or syphilis.
* Allergic to any component of the investigational drug.
