A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD)
NCT ID: NCT03921411
Last Updated: 2023-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2019-04-09
2020-08-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nemolizumab
Nemolizumab
Nemolizumab
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
Interventions
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Nemolizumab
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
Eligibility Criteria
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Inclusion Criteria
* Chronic AD that has been documented for at least 2 years
* Eczema Area and Severity Index (EASI) score ≥ 16
* Investigator's Global Assessment (IGA) score ≥ 3
* AD involvement ≥ 10% of Body Surface Area (BSA)
* Documented recent history of inadequate response to topical medications
* Women of childbearing potential must agree to be strictly abstinent or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.
Exclusion Criteria
* Cutaneous infection within 1 week or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week
* History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, example., monoclonal antibody)
* Any medical or psychological condition, or any clinically relevant laboratory abnormalities that may have put the subject at significant risk according to the investigator's judgment
12 Years
17 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
Fountain Valley, California, United States
Galderma Investigational Site
Fremont, California, United States
Galderma Investigational Site
Jacksonville, 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
Gresham, Oregon, United States
Galderma Investigational Site
Dallas, Texas, United States
Galderma Investigational Site
Frisco, Texas, United States
Galderma Investigational Site
Richmond, Virginia, United States
Countries
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References
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Sidbury R, Alpizar S, Laquer V, Dhawan S, Abramovits W, Loprete L, Krishnaswamy JK, Ahmad F, Jabbar-Lopez Z, Piketty C. Pharmacokinetics, Safety, Efficacy, and Biomarker Profiles During Nemolizumab Treatment of Atopic Dermatitis in Adolescents. Dermatol Ther (Heidelb). 2022 Mar;12(3):631-642. doi: 10.1007/s13555-021-00678-7. Epub 2022 Jan 28.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RD.06.SPR.116912
Identifier Type: -
Identifier Source: org_study_id
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