COMPLETED

Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis

Conditions

Moderate-to-Severe Atopic Dermatitis Atopic Dermatitis Nemolizumab CD14152

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess the pharmacokinetics (PK), efficacy, and safety of nemolizumab in pediatric participants with moderate-to-severe atopic dermatitis (AD).

Official Title

A Multicenter, Open-Label, Single-Group Clinical Trial to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab (CD14152) in Pediatric Subjects (Aged 2 to 11 Years) With Moderate-to-Severe Atopic Dermatitis

Quick Facts

Study Start:2021-06-24

Study Completion:2025-04-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04921345

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* Chronic AD that has been documented for at least 6 months for participants aged 2-6 years and at least 1 year for participants aged 7-11 years before the screening visit and confirmed according to the American Academy of Dermatology Consensus Criteria at the time of the screening visit * 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 * Other protocol defined inclusion criteria could apply	* Body weight less than 10 kilogram (kg) * 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. * Other protocol defined exclusion criteria could apply

Inclusion Criteria

Exclusion Criteria

* Chronic AD that has been documented for at least 6 months for participants aged 2-6 years and at least 1 year for participants aged 7-11 years before the screening visit and confirmed according to the American Academy of Dermatology Consensus Criteria at the time of the screening visit
* 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
* Other protocol defined inclusion criteria could apply

* Body weight less than 10 kilogram (kg)
* 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.
* Other protocol defined exclusion criteria could apply

Contacts and Locations

Study Locations (Sites)

Galderma Investigational Site #8636

Fountain Valley, California, 92708-3701

United States

Galderma Investigational Site #9937

San Diego, California, 92123-2746

United States

Galderma Investigational Site #9930

Vista, California, 92083-6031

United States

Galderma Investigational Site #9929

Coral Gables, Florida, 92083-6031

United States

Galderma Investigational Site #8142

Indianapolis, Indiana, 46250-2041

United States

Galderma Investigational Site #8092

Louisville, Kentucky, 40217-1444

United States

Galderma Investigational Site #8155

Troy, Michigan, 48084-5260

United States

Galderma Investigational Site #8560

West Bloomfield, Michigan, 48322

United States

Galderma Investigational Site #8242

Brooklyn, New York, 11203-2012

United States

Galderma Investigational Site #9938

New York, New York, 10032-3729

United States

Galderma Investigational Site #8206

Norman, Oklahoma, 73069-6301

United States

Galderma Investigational Site #8255

Philadelphia, Pennsylvania, 19103-4708

United States

Galderma Investigational Site #9931

Beaumont, Texas, 77706-3061

United States

Galderma Investigational Site #78218-3128

San Antonio, Texas, 78218-3128

United States

Collaborators and Investigators

Sponsor: Galderma R&D

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-24

Study Completion Date2025-04-28

Study Record Updates

Study Start Date2021-06-24

Study Completion Date2025-04-28

Terms related to this study

Keywords Provided by Researchers

Atopic Dermatitis
Nemolizumab
CD14152

Additional Relevant MeSH Terms

Moderate-to-Severe Atopic Dermatitis