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

Prior treatment

• 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.
• History of a major or unstable clinical condition within 6 months prior to the first dose, which would compromise participation.
• Previous or current autoimmune diseases.
• Allergic to any component of the investigational drug.

Other illness

• Other active skin conditions that may interfere with AD assessment.
• 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 malignant tumour within 5 years before screening.
• Positive results of confirmatory test for hepatitis B, hepatitis C, human
• immunodeficiency virus (HIV) or syphilis.

• 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.