Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis
NCT ID: NCT04921345
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
105 participants
INTERVENTIONAL
2021-06-24
2025-04-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: Participants aged 7-11 year
Participants aged 7-11 years will receive nemolizumab for 52 weeks.
Nemolizumab
Participants will receive subcutaneous (SC) injection of 10, 20 or 30 milligrams (mg) nemolizumab, every 4 weeks (Q4W) for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight.
Cohort 1.1: Participants aged 7-11 years
Participants aged 7-11 years will receive nemolizumab for 52 weeks.
Nemolizumab
Participants will receive SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight.
Cohort 2: Participants aged 2-6 years
Participants aged 2-6 years will receive nemolizumab for 52 weeks.
Nemolizumab
Participants will receive SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight.
Interventions
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Nemolizumab
Participants will receive subcutaneous (SC) injection of 10, 20 or 30 milligrams (mg) nemolizumab, every 4 weeks (Q4W) for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight.
Nemolizumab
Participants will receive SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* EASI score \>=16 at both screening and baseline visits
* IGA score \>=3 at both screening and baseline visits
* AD involvement \>=10% of BSA at both screening and baseline visits
* Peak (maximum) PP NRS score of at least 4.0 at both screening and baseline visits
* Agree to apply a moisturizer throughout the study from the screening visit daily, and liberally as needed; agree to apply an authorized topical corticosteroids (TCS) from the screening visit and throughout the study as determined appropriate by the investigator
* Participant and caregiver willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol
Exclusion Criteria
* Child in Care: a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation
* Participants with a current medical history of chronic bronchitis
* Requiring rescue therapy for AD during the run-in period or expected to require rescue therapy within 2 weeks following the baseline visit
* Positive serology results for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), hepatitis C (HCV) antibody with positive confirmatory test for HCV (example; polymerase chain reaction \[PCR\]), or human immunodeficiency virus (HIV) antibody at the screening visit
* History of lymphoproliferative disease, hypersensitivity (including anaphylaxis) to an immunoglobulin product and intolerance to low or mid potency topical corticosteroids
* Known or suspected immunosuppression
* Participants unwilling to refrain from using prohibited medications during the clinical trial.
2 Years
12 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 #8636
Fountain Valley, California, United States
Galderma Investigational Site #9937
San Diego, California, United States
Galderma Investigational Site #9930
Vista, California, United States
Galderma Investigational Site #9929
Coral Gables, Florida, United States
Galderma Investigational Site #8142
Indianapolis, Indiana, United States
Galderma Investigational Site #8092
Louisville, Kentucky, United States
Galderma Investigational Site #8155
Troy, Michigan, United States
Galderma Investigational Site #8560
West Bloomfield, Michigan, United States
Galderma Investigational Site #8242
Brooklyn, New York, United States
Galderma Investigational Site #9938
New York, New York, United States
Galderma Investigational Site #8206
Norman, Oklahoma, United States
Galderma Investigational Site #8255
Philadelphia, Pennsylvania, United States
Galderma Investigational Site #9931
Beaumont, Texas, United States
Galderma Investigational Site #78218-3128
San Antonio, Texas, United States
Galderma Investigational Site #6218
Hellerup, , Denmark
Galderma Investigational Site #6147
Budapest, , Hungary
Galderma Investigational Site #5531
Szeged, , Hungary
Galderma Investigational Site #5570
Lodz, , Poland
Galderma Investigational Site #6237
Ostrowiec Świętokrzyski, , Poland
Galderma Investigational Site #5495
Rzeszów, , Poland
Galderma Investigational Site #6262
Warsaw, , Poland
Galderma Investigational Site #6261
Wroclaw, , Poland
Galderma Investigational Site #5896
Esplugues de Llobregat, , Spain
Countries
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Other Identifiers
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RD.06.SPR.118126
Identifier Type: -
Identifier Source: org_study_id
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