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

Galderma R&D109 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

109

Conditions

Moderate-to-Severe Atopic Dermatitis

Interventions

NemolizumabDRUG

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.

NemolizumabDRUG

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion 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 Exclusion Criteria: * 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

Locations (23)

Galderma Investigational Site #8636

Fountain Valley, California, United States

Outcomes

Primary Outcomes

Nemolizumab Serum Concentrations

Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).

Time frame: At Weeks 4, 8, 12, 16, 32 and 52

Apparent Total Body Clearance (Cl/F) of Nemolizumab

CL/F is apparent clearance of the drug from the serum, calculated as the drug dose divided area under the curve from time 0 extrapolated to infinite time \[AUC (0-inf)\]. Individual nemolizumab.

Time frame: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52

Apparent Volume of Distribution (Vd/F) of Nemolizumab

Vd/F was calculated as dose divided by lambda\_z \*AUC(0-inf).

Time frame: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52

Absorption Rate Constant (Ka) of Nemolizumab

Time frame: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52

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

Time frame: Pre-dose at Weeks 4, 8, 12, and 16

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

Time frame: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52

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

Time frame: Pre-dose at Weeks 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)

AE defined as any untoward medical occurrence in clinical study participant administered a medicinal product which does not necessarily have causal relationship with this treatment. TEAEs defined as AEs occurring after first administration of study drug during the study. SAE was any untoward medical occurrence, in view of either Investigator or Sponsor, that resulted in death, was life-threatening, resulted in inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was important medical event. AESI was noteworthy TEAE for study drug that was to be monitored closely and reported promptly. Relatedness to study drug was based on Investigator's discretion. AEs Leading to study treatment withdrawal and AEs Leading to study withdrawal will also be reported.

Data from ClinicalTrials.gov

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Secondary Outcomes

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