Dose-ranging Study of Nemolizumab in Atopic Dermatitis
Status: | Completed |
---|---|
Conditions: | Psoriasis, Dermatology, Dermatology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/26/2018 |
Start Date: | June 14, 2017 |
End Date: | September 21, 2018 |
Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Dose-ranging Study to Assess the Efficacy and Safety of Nemolizumab in Moderate-to-severe Atopic Dermatitis Subjects With Severe Pruritus Receiving TCS
Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe AD
subjects with severe pruritus receiving TCS, who were not adequately controlled with topical
treatments.
subjects with severe pruritus receiving TCS, who were not adequately controlled with topical
treatments.
The aim of the study is to assess the efficacy of several subcutaneous doses of nemolizumab
in moderate-to-severe AD subjects with severe pruritus receiving topical corticosteroids, who
were not adequately controlled with topical treatments.
in moderate-to-severe AD subjects with severe pruritus receiving topical corticosteroids, who
were not adequately controlled with topical treatments.
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
- 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
We found this trial at
25
sites
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