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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04921345
Recruitment Status : Recruiting
First Posted : June 10, 2021
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

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).

Condition or disease Intervention/treatment Phase
Moderate-to-Severe Atopic Dermatitis Drug: Nemolizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 24, 2021
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Cohort 1: Participants aged 7-11 years
Participants aged 7-11 years will receive nemolizumab for 52 weeks.
Drug: Nemolizumab
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.
Other Name: CD14152

Experimental: Cohort 2: Participants aged 2-6 years
Participants aged 2-6 years will receive nemolizumab for 52 weeks.
Drug: Nemolizumab
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.
Other Name: CD14152




Primary Outcome Measures :
  1. Nemolizumab Serum Concentrations of Pediatric Participants [ Time Frame: At Week 4, 8, 12, 16, 32 and 52 ]
  2. Apparent Total Body Clearance (Cl/F) of Nemolizumab [ Time Frame: At Week 4, 8, 12, 16, 32 and 52 ]
  3. Apparent Volume of Distribution (Vd/F) of Nemolizumab [ Time Frame: At Week 4, 8, 12, 16, 32 and 52 ]
  4. Absorption Rate Constant (Ka) of Nemolizumab [ Time Frame: At Week 4, 8, 12, 16, 32 and 52 ]
  5. Maximum Observed Serum Concentration (Cmax) of Nemolizumab [ Time Frame: At Week 4, 8, 12, 16, 32 and 52 ]
  6. Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Nemolizumab [ Time Frame: At Week 4, 8, 12, 16, 32 and 52 ]
  7. Time to Reach the Maximum Observed Serum Concentration (Tmax) of Nemolizumab [ Time Frame: At Week 4, 8, 12, 16, 32 and 52 ]
  8. 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 ]
  9. Apparent Terminal Half-life (t1/2) of Nemolizumab [ Time Frame: At Week 4, 8, 12, 16, 32 and 52 ]

Secondary Outcome Measures :
  1. Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Each Visit up to Week 52 [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 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.

  2. Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score at Each Visit up to Week 52 [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 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.

  3. 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 [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 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. EASI-50, EASI-75 and EASI-90 responders will be the participants who achieved >=50%, >=75% and >=90% overall improvement in EASI score respectively from baseline to Week 52.

  4. Investigator's Global Assessment (IGA) Success Rate at Each Visit up to Week 52 [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 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).

  5. Change From Baseline in Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD) [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
  6. Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) Score at Each Visit up to Week 52 [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 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.

  7. Percent Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) Score at Each Visit up to Week 52 [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 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.

  8. 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 [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 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.

  9. Absolute Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Each Visit up to Week 52 [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 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.

  10. Percent Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Each Visit up to Week 52 [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 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.

  11. Absolute Change From Baseline in Weekly Average of Sleep Disturbance Numeric Rating Scale (NRS) Score at Each Visit up to Week 52 [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 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.

  12. Percent Change From Baseline in Weekly Average of Sleep Disturbance Numeric Rating Scale (NRS) Score at Each Visit up to Week 52 [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 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.

  13. Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Each Visit up to Week 52 [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 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).

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

  15. 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 [ Time Frame: Baseline, 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).

  16. Change From Baseline in Patient-Oriented Eczema Measure (POEM) up to Week 16 and Week 52 [ Time Frame: Baseline, 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]).

  17. Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in Peak Pruritus Numeric Rating Scale (PP NRS) [ Time Frame: Baseline, Week 16 and Week 52 ]
    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.

  18. Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in Eczema Area and Severity Index (EASI) Score [ Time Frame: Baseline, Week 16 and Week 52 ]
    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.

  19. Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in Investigator's Global Assessment (IGA) Score [ Time Frame: Baseline, Week 16 and Week 52 ]
    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.

  20. Number of Participants with Positive Anti-Drug Antibody (ADA) for Nemolizumab [ Time Frame: Baseline, Week 16 and Week 52 ]
  21. Number of Participants With Adverse Events (AEs), Including Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESI), AEs Leading to Discontinuation and Serious Adverse Events (SAEs) [ Time Frame: Baseline through week 52 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04921345


Contacts
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Contact: Galderma Research & Development 817-961-5000 clinical.studies@galderma.com

Locations
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Sponsors and Collaborators
Galderma R&D
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT04921345    
Other Study ID Numbers: RD.06.SPR.118126
First Posted: June 10, 2021    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Galderma R&D:
Atopic Dermatitis
Nemolizumab
CD14152
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases