Clinical trial

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

Name

RD.06.SPR.116912

Description

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

Trial arms

Trial start

2019-04-09

Estimated PCD

2020-08-19

Trial end

2020-08-19

Status

Completed

Phase

Early phase I

Treatment

Nemolizumab

Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.

Arms:

Nemolizumab

Size

Primary endpoint

Nemolizumab Serum Concentrations at Week 1-2

At week 1-2

Nemolizumab Serum Concentrations at Week 4

At week 4

Nemolizumab Serum Concentrations at Week 8

At week 8

Nemolizumab Serum Concentrations at Week 12

At week 12

Nemolizumab Serum Concentrations at Week 16

At week 16

Nemolizumab Serum Concentrations at Week 24

At week 24

Apparent Clearance After Extravascular Administration (Cl/F) of Nemolizumab

Baseline to week 24

Apparent Volume of Distribution After Extravascular Administration (Vd/F) of Nemolizumab

Baseline to week 24

Population Lag Time (Tlag)

Baseline to week 24

First Order Constant of Absorption (ka)

Baseline to week 24

Maximum Observed Serum Concentration (Cmax) of Nemolizumab

Baseline to week 12

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

Baseline to week 12

Trough Serum Concentration (Ctrough) of Nemolizumab at Week 4

At week 4

Trough Serum Concentration (Ctrough) of Nemolizumab at Week 8

At week 8

Trough Serum Concentration (Ctrough) of Nemolizumab at Week 12

At week 12

Trough Serum Concentration (Ctrough) of Nemolizumab at Week 16

At week 16

Area Under the Serum Concentration-Time Curve From Zero to 4 Week Post-dose (AUC0-4w)

Pre-dose through 4 weeks post-dose

Area Under the Serum Concentration-Time Curve From Time Zero to 8 Week Post-dose (AUC0-8w)

Pre-dose through 8 weeks post-dose

Area Under the Serum Concentration-Time Curve From Time Zero to 12 Week Post-dose (AUC0-12w)

Pre-dose through 12 week post-dose

Area Under the Serum Concentration-Time Curve From Time Zero to 16 Week Post-dose (AUC0-16w)

Pre-dose through 16 weeks post-dose

Apparent Terminal Half-life (t1/2)

Baseline to week 24

Number of Participants With Treatment-Related Positive Anti-Drug Antibodies (ADA) in Serum at Week 4

At week 4

Number of Participants With Neutralizing Antibodies

Baseline up to Week 24

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Event of Special Interests (AESI) and Serious Adverse Events (SAEs)

Baseline through week 24

Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 1-2

At week 1-2

Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 4

At week 4

Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 8

At week 8

Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 12

At week 12

Number of Participants With Clinically Significant Abnormalities in Physical Examination (PE) Findings

Baseline up to Week 24

Number of Participants With Clinically Significant Abnormalities in Laboratory Values

Baseline up to Week 24

Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings at Week 16

At week 16

Number of Participants With Clinically Significant Abnormalities in Vital Signs

Baseline up to Week 24

Number of Participants With Abnormal Peak Expiratory Flow (PEF) <80% of Predicted Value at Week 1-2

At week 1-2

Number of Participants With Abnormal Peak Expiratory Flow (PEF) <80% Predicted Value at Week 4

At week 4

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

Updated at

2023-04-21

1 organization

1 product

1 indication

Organization

Galderma R&D

Product

Nemolizumab

Indication

Atopic Dermatitis