Phase 2
Completed N=20
A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD)
Source: ClinicalTrials.gov NCT03921411 ↗Enrolled (actual)
20
Serious AEs
11.1%
Results posted
Apr 2023
Primary outcomePrimary: Nemolizumab Serum Concentrations at Week 1-2 — 6478.8 nanogram per milliliter (ng/mL)
Summary
The purpose of this study was to evaluate the pharmacokinetics and safety of nemolizumab in adolescent participants with AD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nemolizumab Serum Concentrations at Week 1-2 |
6478.8 | — |
| PRIMARY Nemolizumab Serum Concentrations at Week 4 |
2935.3 | — |
| PRIMARY Nemolizumab Serum Concentrations at Week 8 |
3292.3 | — |
| PRIMARY Nemolizumab Serum Concentrations at Week 12 |
3221.6 | — |
| PRIMARY Nemolizumab Serum Concentrations at Week 16 |
3010.0 | — |
| PRIMARY Nemolizumab Serum Concentrations at Week 24 |
473.9 | — |
| PRIMARY Apparent Clearance After Extravascular Administration (Cl/F) of Nemolizumab |
0.325 | — |
| PRIMARY Apparent Volume of Distribution After Extravascular Administration (Vd/F) of Nemolizumab |
7.15 | — |
| PRIMARY Population Lag Time (Tlag) |
1.0728 | — |
| PRIMARY First Order Constant of Absorption (ka) |
0.402 | — |
| PRIMARY Maximum Observed Serum Concentration (Cmax) of Nemolizumab |
5975.5 | — |
| PRIMARY Time to Reach Maximum Observed Serum Concentration (Tmax) of Nemolizumab |
5.862 | — |
| PRIMARY Trough Serum Concentration (Ctrough) of Nemolizumab at Week 4 |
3271.859 | — |
| PRIMARY Trough Serum Concentration (Ctrough) of Nemolizumab at Week 8 |
3056.496 | — |
| PRIMARY Trough Serum Concentration (Ctrough) of Nemolizumab at Week 12 |
2886.796 | — |
| PRIMARY Trough Serum Concentration (Ctrough) of Nemolizumab at Week 16 |
2981.792 | — |
| PRIMARY Area Under the Serum Concentration-Time Curve From Zero to 4 Week Post-dose (AUC0-4w) |
144046.235 | — |
| PRIMARY Area Under the Serum Concentration-Time Curve From Time Zero to 8 Week Post-dose (AUC0-8w) |
284397.143 | — |
| PRIMARY Area Under the Serum Concentration-Time Curve From Time Zero to 12 Week Post-dose (AUC0-12w) |
411707.857 | — |
| PRIMARY Area Under the Serum Concentration-Time Curve From Time Zero to 16 Week Post-dose (AUC0-16w) |
549489.167 | — |
| PRIMARY Apparent Terminal Half-life (t1/2) |
16.666 | — |
| PRIMARY Number of Participants With Treatment-Related Positive Anti-Drug Antibodies (ADA) in Serum at Week 4 |
1 | — |
| PRIMARY Number of Participants With Neutralizing Antibodies |
— | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Event of Special Interests (AESI) and Serious Adverse Events (SAEs) |
6; 2; 2 | — |
| PRIMARY Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 1-2 |
— | — |
| PRIMARY Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 4 |
— | — |
| PRIMARY Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 8 |
— | — |
| PRIMARY Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 12 |
1 | — |
| PRIMARY Number of Participants With Clinically Significant Abnormalities in Physical Examination (PE) Findings |
2 | — |
| PRIMARY Number of Participants With Clinically Significant Abnormalities in Laboratory Values |
6; 5; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings at Week 16 |
— | — |
| PRIMARY Number of Participants With Clinically Significant Abnormalities in Vital Signs |
5 | — |
| PRIMARY Number of Participants With Abnormal Peak Expiratory Flow (PEF) <80% of Predicted Value at Week 1-2 |
1 | — |
| PRIMARY Number of Participants With Abnormal Peak Expiratory Flow (PEF) <80% Predicted Value at Week 4 |
1 | — |
| SECONDARY Non-Compartmental Analysis: Area Under the Serum Concentration-time Curve From Time Zero to 4 Weeks Post-dose AUC(0-4w) |
122286.736 | — |
| SECONDARY Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 8 Week Post-dose (AUC0-8w) |
233258.841 | — |
| SECONDARY Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 12 Week Post-dose (AUC0-12w) |
332928.434 | — |
| SECONDARY Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 16 Week Post-dose (AUC0-16w) |
372858.017 | — |
| SECONDARY Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16 |
-15.994 | — |
| SECONDARY Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16 |
-66.52 | — |
| SECONDARY 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 |
7 | — |
| SECONDARY Change From Baseline in the Percentage of Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD) at Each Visit up to Week 24 |
-1.9; -7.1; -11.2; -17.2; -19.9; -14.7 | — |
| SECONDARY Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (NRS) Score at Week 16 |
-3.122 | — |
| SECONDARY Percent Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (NRS) Score at Week 16 |
-43.21 | — |
| SECONDARY Absolute Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Week 16 |
-2.610 | — |
| SECONDARY Percent Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Week 16 |
-40.85 | — |
| SECONDARY Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) Score at Week 16 |
-3.050 | — |
| SECONDARY Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) Score at Week 16 |
-53.51 | — |
| SECONDARY Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 16 |
-50.08 | — |
| SECONDARY Number of Topical Atopic Dermatitis Medication-Free Days Through Week 24 |
3.5; 7.5; 12.1; 9.7; 10.7; 23.4 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) For Participants > 16 Years of Age at Baseline and Week 16 |
11.8; 3.0 | — |
| SECONDARY Children's Dermatology Life Quality Index (cDLQI) For Participants 12-16 Years of Age at Baseline and Week 16 |
10.6; 6.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT03921411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.