Clinical trial NCT04921345: Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Moderate-to-Severe Atopic Dermatitis
Keywords: Atopic Dermatitis
Nemolizumab
CD14152
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2021-06-10
Enrollment: 105
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Nemolizumab Serum Concentrations of Pediatric Participants
timeFrame: At Week 4, 8, 12, 16, 32 and 52
measure: Apparent Total Body Clearance (Cl/F) of Nemolizumab
timeFrame: At Week 4, 8, 12, 16, 32 and 52
measure: Apparent Volume of Distribution (Vd/F) of Nemolizumab
timeFrame: At Week 4, 8, 12, 16, 32 and 52
measure: Absorption Rate Constant (Ka) of Nemolizumab
timeFrame: At Week 4, 8, 12, 16, 32 and 52
measure: Maximum Observed Serum Concentration (Cmax) of Nemolizumab
timeFrame: At Week 4, 8, 12, 16, 32 and 52
measure: Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Nemolizumab
timeFrame: At Week 4, 8, 12, 16, 32 and 52
measure: Time to Reach the Maximum Observed Serum Concentration (Tmax) of Nemolizumab
timeFrame: At Week 4, 8, 12, 16, 32 and 52
measure: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Nemolizumab
timeFrame: At Week 4, 8, 12, 16, 32 and 52
measure: Apparent Terminal Half-life (t1/2) of Nemolizumab
timeFrame: At Week 4, 8, 12, 16, 32 and 52
measure: 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)
timeFrame: Baseline through Week 52
Secondary outcomes:
measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Each Visit up to Week 52
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score at Each Visit up to Week 52
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: 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
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Investigator's Global Assessment (IGA) Success Rate at Each Visit up to Week 52
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Change From Baseline in Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD)
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) Score at Each Visit up to Week 52
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) Score at Each Visit up to Week 52
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Proportion of Participants With an Improvement of >= 4 From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) at Each Visit up to Week 52
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Absolute Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Each Visit up to Week 52
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Each Visit up to Week 52
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Absolute Change From Baseline in Weekly Average of Sleep Disturbance Numeric Rating Scale (NRS) Score at Each Visit up to Week 52
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Change From Baseline in Weekly Average of Sleep Disturbance Numeric Rating Scale (NRS) Score at Each Visit up to Week 52
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Proportion of Participants Receiving any Rescue Therapy by Rescue Treatment
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Each Visit up to Week 52
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) For Participants >=4 Years of Age up to Week 16 and Week 52
timeFrame: Baseline, Week 16 and Week 52
measure: Change From Baseline in Infants' Dermatology Life Quality Index (iDLQI) For Participants <4 Years of Age From Baseline up to Week 16 and up to Week 52
timeFrame: Baseline, Week 16 and Week 52
measure: Change From Baseline in Patient-Oriented Eczema Measure (POEM) up to Week 16 and Week 52
timeFrame: Baseline, Week 16 and Week 52
measure: Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in Peak Pruritus Numeric Rating Scale (PP NRS)
timeFrame: Baseline, Week 16 and Week 52
measure: Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in Eczema Area and Severity Index (EASI) Score
timeFrame: Baseline, Week 16 and Week 52
measure: Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in Investigator's Global Assessment (IGA) Score
timeFrame: Baseline, Week 16 and Week 52
measure: Number of Participants with Positive Anti-Drug Antibody (ADA) for Nemolizumab
timeFrame: Baseline, Week 16 and Week 52
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Galderma Investigational Site #8636
state: California
city: San Diego
country: United States
facility: Galderma Investigational Site #9937
state: California
city: Vista
country: United States
facility: Galderma Investigational Site #9930
state: California
city: Coral Gables
country: United States
facility: Galderma Investigational Site #9929
state: Florida
city: Indianapolis
country: United States
facility: Galderma Investigational Site #8142
state: Indiana
city: Louisville
country: United States
facility: Galderma Investigational Site #8092
state: Kentucky
city: Troy
country: United States
facility: Galderma Investigational Site #8155
state: Michigan
city: West Bloomfield
country: United States
facility: Galderma Investigational Site #8560
state: Michigan
city: Brooklyn
country: United States
facility: Galderma Investigational Site #8242
state: New York
city: New York
country: United States
facility: Galderma Investigational Site #9938
state: New York
city: Norman
country: United States
facility: Galderma Investigational Site #8206
state: Oklahoma
city: Philadelphia
country: United States
facility: Galderma Investigational Site #8255
state: Pennsylvania
city: Beaumont
country: United States
facility: Galderma Investigational Site #9931
state: Texas
city: San Antonio
country: United States
facility: Galderma Investigational Site #78218-3128
state: Texas
city: Hellerup
country: Denmark
facility: Galderma Investigational Site #6218
city: Budapest
country: Hungary
facility: Galderma Investigational Site #6147
city: Szeged
country: Hungary
facility: Galderma Investigational Site #5531
city: Ostrowiec Świętokrzyski
country: Poland
facility: Galderma Investigational Site #6237
city: Rzeszów
country: Poland
facility: Galderma Investigational Site #5495
city: Warszawa
country: Poland
facility: Galderma Investigational Site #6262
city: Wrocław
country: Poland
facility: Galderma Investigational Site #6261
city: Łódź
country: Poland
facility: Galderma Investigational Site #5570
city: Esplugues De Llobregat
country: Spain
facility: Galderma Investigational Site #5896
Study officials:
References: