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

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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.

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.

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
Richmond, Virginia 23220
2350
mi
from 98109
Richmond, VA
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?
mi
from 98109
Benowa,
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Beverly Hills, California 90212
959
mi
from 98109
Beverly Hills, CA
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Birmingham, Alabama
2079
mi
from 98109
Birmingham, AL
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Chapel Hill, North Carolina 27516
2167
mi
from 98109
Chapel Hill, NC
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Columbus, Georgia 31904
2202
mi
from 98109
Columbus, GA
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Dallas, Texas 75230
1680
mi
from 98109
Dallas, TX
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Darien, Illinois 60561
1719
mi
from 98109
Darien, IL
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Farmington Hills, Michigan 78334
1913
mi
from 98109
Farmington Hills, MI
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Forest Hills, New York 11375
2409
mi
from 98109
Forest Hills, NY
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Fort Smith, Arkansas 72916
1661
mi
from 98109
Fort Smith, AR
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Fountain Valley, California 92708
988
mi
from 98109
Fountain Valley, CA
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Fremont, California 94538
700
mi
from 98109
Fremont, CA
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Johnston, Rhode Island 02919
2481
mi
from 98109
Johnston, RI
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2729
mi
from 98109
Miami, FL
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New Orleans, Louisiana 70130
2099
mi
from 98109
New Orleans, LA
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New York, New York 10022
2262
mi
from 98109
New York, NY
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Overland Park, Kansas 66215
1503
mi
from 98109
Overland Park, KS
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Rolling Hills Estates, California 90274
979
mi
from 98109
Rolling Hills Estates, CA
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San Antonio, Texas
1787
mi
from 98109
San Antonio, TX
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Sandy Springs, Georgia 30328
2171
mi
from 98109
Sandy Springs, GA
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Santa Ana, California 92705
987
mi
from 98109
Santa Ana, CA
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Santa Monica, California
961
mi
from 98109
Santa Monica, CA
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2527
mi
from 98109
Tampa, FL
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Waco, Texas 76705
1728
mi
from 98109
Waco, TX
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