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

Primary Purpose

Moderate-to-Severe Atopic Dermatitis

Status

Recruiting

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Nemolizumab

About this trial

This is an interventional treatment trial for Moderate-to-Severe Atopic Dermatitis focused on measuring Atopic Dermatitis, Nemolizumab, CD14152

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cohort 1: Participants aged 7-11 years

Cohort 1.1: Participants aged 7-11 years

Cohort 2: Participants aged 2-6 years

Arm Description

Participants aged 7-11 years will receive nemolizumab for 52 weeks.

Participants aged 2-6 years will receive nemolizumab for 52 weeks.

Outcomes

Primary Outcome Measures

Nemolizumab Serum Concentrations of Pediatric Participants

Apparent Total Body Clearance (Cl/F) of Nemolizumab

Apparent Volume of Distribution (Vd/F) of Nemolizumab

Absorption Rate Constant (Ka) of Nemolizumab

Maximum Observed Serum Concentration (Cmax) of Nemolizumab

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

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

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

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

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)

Secondary Outcome Measures

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

EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity will be assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score can range from 0 to 72 with higher scores representing greater severity of atopic dermatitis.

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

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

Investigator's Global Assessment (IGA) Success Rate at Each Visit up to Week 52

IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of AD. The Investigator will review the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe).

Change From Baseline in Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD)

Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) Score at Each Visit up to Week 52

Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.

Percent Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) Score at Each Visit up to Week 52

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

Absolute Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Each Visit up to Week 52

Percent Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Each Visit up to Week 52

Absolute Change From Baseline in Weekly Average of Sleep Disturbance Numeric Rating Scale (NRS) Score at Each Visit up to Week 52

The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants will be asked the following questions in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicate worse outcome.

Percent Change From Baseline in Weekly Average of Sleep Disturbance Numeric Rating Scale (NRS) Score at Each Visit up to Week 52

Proportion of Participants Receiving any Rescue Therapy by Rescue Treatment

Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Each Visit up to Week 52

SCORAD is a clinical tool for assessing the severity and the extent of AD signs and symptoms. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).

Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) For Participants >=4 Years of Age up to Week 16 and Week 52

The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant will rate each question ranging from 0 (not at all) to 3 (very much) and score ranges from 0 to 30. A higher total score indicates a poorer quality of life (QoL).

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

Change From Baseline in Patient-Oriented Eczema Measure (POEM) up to Week 16 and Week 52

The POEM is a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).

Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in Peak Pruritus Numeric Rating Scale (PP NRS)

The relationship between nemolizumab serum concentrations will be evaluated using correlation and/or linear regression methods to evaluate possible associations with changes in PP-NRS score.

Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in Eczema Area and Severity Index (EASI) Score

The relationship between nemolizumab serum concentrations will be evaluated using correlation and/or linear regression methods to evaluate possible associations with changes in EASI score.

Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in Investigator's Global Assessment (IGA) Score

The relationship between nemolizumab serum concentrations will be evaluated using correlation and/or linear regression methods to evaluate possible associations with changes in IGA score.

Number of Participants with Positive Anti-Drug Antibody (ADA) for Nemolizumab

Full Information

NCT ID

NCT04921345

First Posted

June 4, 2021

Last Updated

April 5, 2023

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT04921345

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 24, 2021 (Actual)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galderma R&D

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Moderate-to-Severe Atopic Dermatitis

Keywords

Atopic Dermatitis, Nemolizumab, CD14152

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1: Participants aged 7-11 years

Arm Type

Experimental

Arm Description

Participants aged 7-11 years will receive nemolizumab for 52 weeks.

Arm Title

Cohort 1.1: Participants aged 7-11 years

Arm Type

Experimental

Arm Description

Participants aged 7-11 years will receive nemolizumab for 52 weeks.

Arm Title

Cohort 2: Participants aged 2-6 years

Arm Type

Experimental

Arm Description

Participants aged 2-6 years will receive nemolizumab for 52 weeks.

Intervention Type

Drug

Intervention Name(s)

Nemolizumab

Other Intervention Name(s)

CD14152

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Nemolizumab

Other Intervention Name(s)

CD14152

Intervention Description

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.

Primary Outcome Measure Information:

Title

Nemolizumab Serum Concentrations of Pediatric Participants

Time Frame

At Week 4, 8, 12, 16, 32 and 52

Title

Apparent Total Body Clearance (Cl/F) of Nemolizumab

Time Frame

At Week 4, 8, 12, 16, 32 and 52

Title

Apparent Volume of Distribution (Vd/F) of Nemolizumab

Time Frame

At Week 4, 8, 12, 16, 32 and 52

Title

Absorption Rate Constant (Ka) of Nemolizumab

Time Frame

At Week 4, 8, 12, 16, 32 and 52

Title

Maximum Observed Serum Concentration (Cmax) of Nemolizumab

Time Frame

At Week 4, 8, 12, 16, 32 and 52

Title

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

Time Frame

At Week 4, 8, 12, 16, 32 and 52

Title

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

Time Frame

At Week 4, 8, 12, 16, 32 and 52

Title

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

Time Frame

At Week 4, 8, 12, 16, 32 and 52

Title

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

Time Frame

At Week 4, 8, 12, 16, 32 and 52

Title

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)

Time Frame

Baseline through Week 52

Secondary Outcome Measure Information:

Title

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

Description

Time Frame