A Phase 2 Study of CIM331 for Atopic Dermatitis Patients

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chugai Pharmaceutical

Criteria

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.