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

NCT04921345 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: RD.06.SPR.118126
• Study Type: interventional
• Target: 105
• Locations: 5 countries
• Sites: 23

Brief Summary

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

Keywords

Atopic Dermatitis; Nemolizumab; CD14152

Outcome Measures

Primary Outcomes (10)

• Nemolizumab Serum Concentrations of Pediatric Participants

  At Week 4, 8, 12, 16, 32 and 52

• Apparent Total Body Clearance (Cl/F) of Nemolizumab

  At Week 4, 8, 12, 16, 32 and 52

• Apparent Volume of Distribution (Vd/F) of Nemolizumab

  At Week 4, 8, 12, 16, 32 and 52

• Absorption Rate Constant (Ka) of Nemolizumab

  At Week 4, 8, 12, 16, 32 and 52

• Maximum Observed Serum Concentration (Cmax) of Nemolizumab

  At Week 4, 8, 12, 16, 32 and 52

• Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Nemolizumab

  At Week 4, 8, 12, 16, 32 and 52

• Time to Reach the Maximum Observed Serum Concentration (Tmax) of Nemolizumab

  At Week 4, 8, 12, 16, 32 and 52

• Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Nemolizumab

  At Week 4, 8, 12, 16, 32 and 52

• Apparent Terminal Half-life (t1/2) of Nemolizumab

  At Week 4, 8, 12, 16, 32 and 52

• Number of Participants with Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), Adverse Events Leading to Discontinuation and Serious Adverse Events (SAEs)

  Baseline through Week 52

Secondary Outcomes (21)

• Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Each Visit up to Week 52

  Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

• Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score at Each Visit up to Week 52

  Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

• Number of Participants Achieving 50%, 75% or 90% Response From Baseline in Eczema Area and Severity Index (EASI-50, EASI-75 and EASI-90) at Each Visit up to Week 52

  Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

• Investigator's Global Assessment (IGA) Success Rate at Each Visit up to Week 52

  Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

• Change From Baseline in Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD)

  Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Study Arms (3)

Cohort 1: Participants aged 7-11 year

EXPERIMENTAL

Participants aged 7-11 years will receive nemolizumab for 52 weeks.

Drug: Nemolizumab

Cohort 1.1: Participants aged 7-11 years

EXPERIMENTAL

Participants aged 7-11 years will receive nemolizumab for 52 weeks.

Drug: Nemolizumab

Cohort 2: Participants aged 2-6 years

EXPERIMENTAL

Participants aged 2-6 years will receive nemolizumab for 52 weeks.

Drug: Nemolizumab

Interventions

Nemolizumab DRUG

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.

Also known as: CD14152

Cohort 1: Participants aged 7-11 year

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (23)

Galderma Investigational Site #8636

Fountain Valley, California, 92708-3701, United States

Location

Galderma Investigational Site #9937

San Diego, California, 92123-2746, United States

Location

Galderma Investigational Site #9930

Vista, California, 92083-6031, United States

Location

Galderma Investigational Site #9929

Coral Gables, Florida, 92083-6031, United States

Location

Galderma Investigational Site #8142

Indianapolis, Indiana, 46250-2041, United States

Location

Galderma Investigational Site #8092

Louisville, Kentucky, 40217-1444, United States

Location

Galderma Investigational Site #8155

Troy, Michigan, 48084-5260, United States

Location

Galderma Investigational Site #8560

West Bloomfield, Michigan, 48322, United States

Location

Galderma Investigational Site #8242

Brooklyn, New York, 11203-2012, United States

Location

Galderma Investigational Site #9938

New York, New York, 10032-3729, United States

Location

Galderma Investigational Site #8206

Norman, Oklahoma, 73069-6301, United States

Location

Galderma Investigational Site #8255

Philadelphia, Pennsylvania, 19103-4708, United States

Location

Galderma Investigational Site #9931

Beaumont, Texas, 77706-3061, United States

Location

Galderma Investigational Site #78218-3128

San Antonio, Texas, 78218-3128, United States

Location

Galderma Investigational Site #6218

Hellerup, 2900, Denmark

Location

Galderma Investigational Site #6147

Budapest, 1036, Hungary

Location

Galderma Investigational Site #5531

Szeged, 6720, Hungary

Location

Galderma Investigational Site #5570

Lodz, 90-265, Poland

Location

Galderma Investigational Site #6237

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Galderma Investigational Site #5495

Rzeszów, 35-055, Poland

Location

Galderma Investigational Site #6262

Warsaw, 02-953, Poland

Location

Galderma Investigational Site #6261

Wroclaw, 51-685, Poland

Location

Galderma Investigational Site #5896

Esplugues de Llobregat, 0850, Spain

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

nemolizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: June 24, 2021
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-06

Locations

PL (5); ES (1); DK (1); HU (2); US (14)