Clinical trial NCT03921411: A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD)
Official title: A Multicenter, Open-Label, Single-Group Clinical Trial to Assess the Pharmacokinetics and Safety of Nemolizumab (CD14152) in Adolescent Subjects (12-17 Years) With Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Nemolizumab
Atopic dermatitis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2019-04-19
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the pharmacokinetics and safety of nemolizumab in adolescent participants with AD.


Eligibility criteria: Key Inclusion Criteria

* Male or female participants ≥ 12 to \< 17 years of age
* Chronic AD that has been documented for at least 2 years
* Eczema Area and Severity Index (EASI) score ≥ 16
* Investigator's Global Assessment (IGA) score ≥ 3
* AD involvement ≥ 10% of Body Surface Area (BSA)
* Documented recent history of inadequate response to topical medications
* Women of childbearing potential must agree to be strictly abstinent or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.

Key Exclusion Criteria

* Body weight \< 30 kilogram (kg)
* Cutaneous infection within 1 week or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week
* History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, example., monoclonal antibody)
* Any medical or psychological condition, or any clinically relevant laboratory abnormalities that may have put the subject at significant risk according to the investigator's judgment

Primary outcomes:
measure: Nemolizumab Serum Concentrations at Week 1-2
timeFrame: At week 1-2
measure: Nemolizumab Serum Concentrations at Week 4
timeFrame: At week 4
measure: Nemolizumab Serum Concentrations at Week 8
timeFrame: At week 8
measure: Nemolizumab Serum Concentrations at Week 12
timeFrame: At week 12
measure: Nemolizumab Serum Concentrations at Week 16
timeFrame: At week 16
measure: Nemolizumab Serum Concentrations at Week 24
timeFrame: At week 24
measure: Apparent Clearance After Extravascular Administration (Cl/F) of Nemolizumab
timeFrame: Baseline to week 24
measure: Apparent Volume of Distribution After Extravascular Administration (Vd/F) of Nemolizumab
timeFrame: Baseline to week 24
measure: Population Lag Time (Tlag)
timeFrame: Baseline to week 24
measure: First Order Constant of Absorption (ka)
timeFrame: Baseline to week 24
measure: Maximum Observed Serum Concentration (Cmax) of Nemolizumab
timeFrame: Baseline to week 12
measure: Time to Reach Maximum Observed Serum Concentration (Tmax) of Nemolizumab
timeFrame: Baseline to week 12
measure: Trough Serum Concentration (Ctrough) of Nemolizumab at Week 4
timeFrame: At week 4
measure: Trough Serum Concentration (Ctrough) of Nemolizumab at Week 8
timeFrame: At week 8
measure: Trough Serum Concentration (Ctrough) of Nemolizumab at Week 12
timeFrame: At week 12
measure: Trough Serum Concentration (Ctrough) of Nemolizumab at Week 16
timeFrame: At week 16
measure: Area Under the Serum Concentration-Time Curve From Zero to 4 Week Post-dose (AUC0-4w)
timeFrame: Pre-dose through 4 weeks post-dose
measure: Area Under the Serum Concentration-Time Curve From Time Zero to 8 Week Post-dose (AUC0-8w)
timeFrame: Pre-dose through 8 weeks post-dose
measure: Area Under the Serum Concentration-Time Curve From Time Zero to 12 Week Post-dose (AUC0-12w)
timeFrame: Pre-dose through 12 week post-dose
measure: Area Under the Serum Concentration-Time Curve From Time Zero to 16 Week Post-dose (AUC0-16w)
timeFrame: Pre-dose through 16 weeks post-dose
measure: Apparent Terminal Half-life (t1/2)
timeFrame: Baseline to week 24
measure: Number of Participants With Treatment-Related Positive Anti-Drug Antibodies (ADA) in Serum at Week 4
timeFrame: At week 4
measure: Number of Participants With Neutralizing Antibodies
timeFrame: Baseline up to Week 24
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Event of Special Interests (AESI) and Serious Adverse Events (SAEs)
timeFrame: Baseline through week 24
measure: Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 1-2
timeFrame: At week 1-2
measure: Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 4
timeFrame: At week 4
measure: Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 8
timeFrame: At week 8
measure: Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 12
timeFrame: At week 12
measure: Number of Participants With Clinically Significant Abnormalities in Physical Examination (PE) Findings
timeFrame: Baseline up to Week 24
measure: Number of Participants With Clinically Significant Abnormalities in Laboratory Values
timeFrame: Baseline up to Week 24
measure: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings at Week 16
timeFrame: At week 16
measure: Number of Participants With Clinically Significant Abnormalities in Vital Signs
timeFrame: Baseline up to Week 24
measure: Number of Participants With Abnormal Peak Expiratory Flow (PEF) <80% of Predicted Value at Week 1-2
timeFrame: At week 1-2
measure: Number of Participants With Abnormal Peak Expiratory Flow (PEF) <80% Predicted Value at Week 4
timeFrame: At week 4
Secondary outcomes:
measure: Non-Compartmental Analysis: Area Under the Serum Concentration-time Curve From Time Zero to 4 Weeks Post-dose AUC(0-4w)
timeFrame: Pre-dose through 4 weeks post-dose
measure: Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 8 Week Post-dose (AUC0-8w)
timeFrame: Pre-dose through 8 weeks post-dose
measure: Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 12 Week Post-dose (AUC0-12w)
timeFrame: Pre-dose through 12 week post-dose
measure: Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 16 Week Post-dose (AUC0-16w)
timeFrame: Pre-dose through 16 weeks post-dose
measure: Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16
timeFrame: Baseline, Week 16
measure: Number of Participants Who Achieved Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Change From Baseline in the Percentage of Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD) at Each Visit up to Week 24
timeFrame: Baseline, Week 1-2, 4, 8, 12, 14, 16 and 24
measure: Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (NRS) Score at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (NRS) Score at Week 16
timeFrame: Baseline, Week 16
measure: Absolute Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Week 16
timeFrame: Baseline, Week 16
measure: Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) Score at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) Score at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 16
timeFrame: Baseline, Week 16
measure: Number of Topical Atopic Dermatitis Medication-Free Days Through Week 24
timeFrame: Baseline through Week 24
measure: Dermatology Life Quality Index (DLQI) For Participants > 16 Years of Age at Baseline and Week 16
timeFrame: Baseline, Week 16
measure: Children's Dermatology Life Quality Index (cDLQI) For Participants 12-16 Years of Age at Baseline and Week 16
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Galderma Investigational Site
state: California
city: Fremont
country: United States
facility: Galderma Investigational Site
state: California
city: Jacksonville
country: United States
facility: Galderma Investigational Site
state: Florida
city: Tampa
country: United States
facility: Galderma Investigational Site
state: Florida
city: Columbus
country: United States
facility: Galderma Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: Galderma Investigational Site
state: Georgia
city: Gresham
country: United States
facility: Galderma Investigational Site
state: Oregon
city: Dallas
country: United States
facility: Galderma Investigational Site
state: Texas
city: Frisco
country: United States
facility: Galderma Investigational Site
state: Texas
city: Richmond
country: United States
facility: Galderma Investigational Site
state: Virginia
Study officials:
References:
citation: Sidbury R, Alpizar S, Laquer V, Dhawan S, Abramovits W, Loprete L, Krishnaswamy JK, Ahmad F, Jabbar-Lopez Z, Piketty C. Pharmacokinetics, Safety, Efficacy, and Biomarker Profiles During Nemolizumab Treatment of Atopic Dermatitis in Adolescents. Dermatol Ther (Heidelb). 2022 Mar;12(3):631-642. doi: 10.1007/s13555-021-00678-7. Epub 2022 Jan 28.