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 |
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
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.
We found this trial at
18
sites
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