A Phase 2 Study of CIM331 for Atopic Dermatitis Patients



Status:Active, not recruiting
Conditions:Psoriasis, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:November 2013
End Date:June 2016

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A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF CIM331 IN ATOPIC DERMATITIS PATIENTS WHO ARE INADEQUATELY CONTROLLED BY OR INTOLERANT TO TOPICAL THERAPY

To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic
dermatitis patients who are inadequately controlled by or intolerant to topical therapy


Inclusion Criteria:

- ≥18 and ≤65 years of age at the time of consent.

- Patients with Atopic Dermatitis

- Pruritus visual analogue scale (VAS) ≥50 mm at the screening and baseline visit

- Eczema Area and Severity Index (EASI) ≥10 at the screening and baseline visit

- static Investigator's Global Assessment (sIGA) score ≥3 at the baseline visit

Exclusion Criteria:

- Serological evidence of hepatitis B virus or hepatitis C virus infection

- Known human immunodeficiency virus infection

- Ongoing treatment with specific or non-specific hyposensitization therapy for AD

- Treatment with mild or moderately potent topical corticosteroids (TCS) within 1 week
prior to randomization

- History of infection including skin infection requiring treatment with oral or
intravenous (IV) antibiotics, antivirals, or antifungals within 1 week prior to
randomization.

- Evidence of tuberculosis (TB) infection as defined by a positive purified protein
derivative (PPD) and/or positive interferon-gamma release assay.

- Pregnant or lactating women.
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18
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Charleston, South Carolina 29412
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Charleston, South Carolina 29412
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Charlotte, North Carolina 28207
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