Dose-ranging Study of Nemolizumab in Atopic Dermatitis

• Status: Completed
• Trial end date: 2018-09-21
• Target enrollment: 0
• Participant gender: All

Summary

Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately controlled with topical treatments.

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

Details

• Lead Sponsor: Galderma R&D

Criteria

Inclusion Criteria:

• Male or female subjects ≥ 18 years (or legal age when higher)

• Chronic AD, that has been present for at least 2 years before the visit

• Eczema Area and Severity Index (EASI) score ≥12

• Investigator Global Assessment (IGA) score ≥ 3

• AD involvement ≥ 10% of Body Surface Area (BSA)

• Severe pruritus on at least 3 of the last 7 days before the visit

• Documented recent history (within 6 months before the visit) of inadequate response to topical medications

• Female subjects must fulfill one of the criteria below:

• Female subjects of non-childbearing potential

• Female subjects of childbearing potential who agree to a true abstinence or to use an effective or highly effective method of contraception throughout the clinical trial and for 120 days after the last study drug administration

Exclusion Criteria:

• Body weight < 45 kg

• subjects with a medical history of asthma requiring hospitalization in the last 12 months before screening visit and/or whose asthma has not been well-controlled during the last 3 months before the screening visit and/or Peak Expiratory Flow (PEF) <80% of the predicted value

• Cutaneous bacterial or viral infection within 1 week before the screening visit or during the run-in period

• Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit or during the run-in period

• History of intolerance to low or mid potency TCS or for whom TCS is not advisable