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
Fountain Valley, California 92708
1966
mi
from 43215
Fountain Valley, CA
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?
mi
from 43215
Benowa,
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Beverly Hills, California 90212
1980
mi
from 43215
Beverly Hills, CA
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Birmingham, Alabama
491
mi
from 43215
Birmingham, AL
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Chapel Hill, North Carolina 27516
278
mi
from 43215
Chapel Hill, NC
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Columbus, Georgia 31904
523
mi
from 43215
Columbus, GA
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Dallas, Texas 75230
911
mi
from 43215
Dallas, TX
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Darien, Illinois 60561
287
mi
from 43215
Darien, IL
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Farmington Hills, Michigan 78334
175
mi
from 43215
Farmington Hills, MI
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Forest Hills, New York 11375
485
mi
from 43215
Forest Hills, NY
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Fort Smith, Arkansas 72916
697
mi
from 43215
Fort Smith, AR
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Fremont, California 94538
2088
mi
from 43215
Fremont, CA
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Johnston, Rhode Island 02919
614
mi
from 43215
Johnston, RI
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992
mi
from 43215
Miami, FL
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New Orleans, Louisiana 70130
797
mi
from 43215
New Orleans, LA
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New York, New York 10022
442
mi
from 43215
New York, NY
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Overland Park, Kansas 66215
624
mi
from 43215
Overland Park, KS
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Richmond, Virginia 23220
342
mi
from 43215
Richmond, VA
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Rolling Hills Estates, California 90274
1985
mi
from 43215
Rolling Hills Estates, CA
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San Antonio, Texas
1138
mi
from 43215
San Antonio, TX
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Sandy Springs, Georgia 30328
424
mi
from 43215
Sandy Springs, GA
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Santa Ana, California 92705
1960
mi
from 43215
Santa Ana, CA
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Santa Monica, California
1986
mi
from 43215
Santa Monica, CA
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830
mi
from 43215
Tampa, FL
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Waco, Texas 76705
980
mi
from 43215
Waco, TX
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