Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
226 participants
INTERVENTIONAL
2017-06-14
2018-09-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1
Nemolizumab (low dose)
Nemolizumab
Injection every 4 weeks during 24 weeks (last injection at week 20)
Group 2
Nemolizumab (medium dose)
Nemolizumab
Injection every 4 weeks during 24 weeks (last injection at week 20)
Group 3
Nemolizumab (high dose)
Nemolizumab
Injection every 4 weeks during 24 weeks (last injection at week 20)
Group 4
Nemolizumab placebo
Placebo
Injection every 4 weeks during 24 weeks (last injection at week 20)
Interventions
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Nemolizumab
Injection every 4 weeks during 24 weeks (last injection at week 20)
Placebo
Injection every 4 weeks during 24 weeks (last injection at week 20)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Locations
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Galderma Investigational site
Birmingham, Alabama, United States
Galderma Investigational site
Fort Smith, Arkansas, United States
Galderma Investigational site
Beverly Hills, California, United States
Galderma Investigational site
Fountain Valley, California, United States
Galderma Investigational site
Fremont, California, United States
Galderma Investigational site
Rolling Hills Estates, California, United States
Galderma Investigational site
Santa Ana, California, United States
Galderma Investigational site
Santa Monica, California, United States
Galderma Investigational site
Miami, Florida, United States
Galderma Investigational site
Tampa, Florida, United States
Galderma Investigational Site
Tampa, Florida, United States
Galderma Investigational site
Columbus, Georgia, United States
Galderma Investigational site
Sandy Springs, Georgia, United States
Galderma Investigational Site
Darien, Illinois, United States
Galderma Investigational Site
Overland Park, Kansas, United States
Galderma Investigational site
New Orleans, Louisiana, United States
Galderma Investigational Site
Farmington Hills, Michigan, United States
Galderma Investigational site
Forest Hills, New York, United States
Galderma Investigational site
New York, New York, United States
Galderma Investigational Site
New York, New York, United States
Galderma Investigational site
Chapel Hill, North Carolina, United States
Galderma Investigational Site
Johnston, Rhode Island, United States
Galderma Investigational site
Dallas, Texas, United States
Galderma Investigational site
San Antonio, Texas, United States
Galderma Investigational Site
Waco, Texas, United States
Galderma Investigational site
Richmond, Virginia, United States
Galderma Investigational Site
Benowa, , Australia
Galderma Investigational Site
Kogarah, , Australia
Galderma Investigational Site
Melbourne, , Australia
Galderma Investigational Site
Phillip, , Australia
Galderma Investigational Site
Calgary, , Canada
Galderma Investigational Site
Markham, , Canada
Galderma Investigational Site
Oakville, , Canada
Galderma Investigational Site
Ottawa, , Canada
Galderma Investigational Site
Ottawa, , Canada
Galderma Investigational Site
Peterborough, , Canada
Galderma Investigational Site
Richmond Hill, , Canada
Galderma Investigational Site
Sainte-Foy, , Canada
Galderma Investigational Site
Waterloo, , Canada
Galderma Investigational Site
Bordeaux, , France
Galderma Investigational Site
Lille, , France
Galderma Investigational Site
Marseille, , France
Galderma Investigational Site
Nice, , France
Galderma Investigational Site
Paris, , France
Galderma Investigational Site
Toulouse, , France
Galderma Investigational Site
Berlin, , Germany
Galderma Investigational Site
Berlin, , Germany
Galderma Investigational Site
Darmstadt, , Germany
Galderma Investigational Site
Erlangen, , Germany
Galderma Investigational Site
Frankfurt, , Germany
Galderma Investigational Site
Hamburg, , Germany
Galderma Investigational Site
Hannover, , Germany
Galderma Investigational Site
Heidelberg, , Germany
Galderma Investigational Site
Langenau, , Germany
Galderma Investigational Site
Mainz, , Germany
Galderma Investigational Site
München, , Germany
Galderma Investigational Site
Osnabrück, , Germany
Galderma Investigational Site
Stuttgart, , Germany
Galderma Investigational Site
Katowice, , Poland
Galderma Investigational Site
Katowice, , Poland
Galderma Investigational Site
Krakow, , Poland
Galderma Investigational Site
Lodz, , Poland
Galderma Investigational Site
Lublin, , Poland
Galderma Investigational Site
Warsaw, , Poland
Galderma Investigational Site
Warsaw, , Poland
Galderma Investigational Site
Warsaw, , Poland
Galderma Investigational Site
Wroclaw, , Poland
Countries
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References
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Silverberg JI, Pinter A, Pulka G, Poulin Y, Bouaziz JD, Wollenberg A, Murrell DF, Alexis A, Lindsey L, Ahmad F, Piketty C, Clucas A. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020 Jan;145(1):173-182. doi: 10.1016/j.jaci.2019.08.013. Epub 2019 Aug 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RD.03.SPR.114322
Identifier Type: -
Identifier Source: org_study_id
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