RECRUITING

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).

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