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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

D001-02-001

Status

Not yet recruiting

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18 to 75 Years
All Sexes

Trial Timing

Started 2 months ago

What is this trial about?

This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial, aiming to evaluate the efficacy, safety, and tolerability of CMS-D001 in participants with moderate to severe atopic dermatitis, as well as to assess the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of CMS-D001 and its major metabolites (as applicable) in participants with moderate to severe atopic dermatitis, so as to provide a basis for the dosage of the Phase III confirmatory clinical trial.

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.