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

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).

Conditions

Moderate-to-Severe Atopic Dermatitis

Study Overview

Study Details

Study overview

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).

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

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

Condition
Moderate-to-Severe Atopic Dermatitis
Intervention / Treatment

-

Contacts and Locations

Fountain Valley

Galderma Investigational Site #8636, Fountain Valley, California, United States, 92708-3701

San Diego

Galderma Investigational Site #9937, San Diego, California, United States, 92123-2746

Vista

Galderma Investigational Site #9930, Vista, California, United States, 92083-6031

Coral Gables

Galderma Investigational Site #9929, Coral Gables, Florida, United States, 92083-6031

Indianapolis

Galderma Investigational Site #8142, Indianapolis, Indiana, United States, 46250-2041

Louisville

Galderma Investigational Site #8092, Louisville, Kentucky, United States, 40217-1444

Troy

Galderma Investigational Site #8155, Troy, Michigan, United States, 48084-5260

West Bloomfield

Galderma Investigational Site #8560, West Bloomfield, Michigan, United States, 48322

Brooklyn

Galderma Investigational Site #8242, Brooklyn, New York, United States, 11203-2012

New York

Galderma Investigational Site #9938, New York, New York, United States, 10032-3729

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

2 Years to 12 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Galderma R&D,

Study Record Dates

2025-07