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

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

The purpose of this study was to assess the pharmacokinetics (PK), safety, and efficacy of nemolizumab in pediatric participants with moderate-to-severe atopic dermatitis (AD).

Study Overview

• Status: Completed
• Conditions: Moderate-to-Severe Atopic Dermatitis
• Intervention / Treatment: Drug: Nemolizumab; Drug: Nemolizumab

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • Galderma Investigational Site #6218
• Hungary
  • Budapest, Hungary, 1036
    • Galderma Investigational Site #6147
  • Szeged, Hungary, 6720
    • Galderma Investigational Site #5531
• Poland
  • Lodz, Poland, 90-265
    • Galderma Investigational Site #5570
  • Ostrowiec Świętokrzyski, Poland, 27-400
    • Galderma Investigational Site #6237
  • Rzeszów, Poland, 35-055
    • Galderma Investigational Site #5495
  • Warsaw, Poland, 02-953
    • Galderma Investigational Site #6262
  • Wroclaw, Poland, 51-685
    • Galderma Investigational Site #6261
• Spain
  • Esplugues de Llobregat, Spain, 0850
    • Galderma Investigational Site #5896
• United States
  • California
    • Fountain Valley, California, United States, 92708-3701
      • Galderma Investigational Site #8636
    • San Diego, California, United States, 92123-2746
      • Galderma Investigational Site #9937
    • Vista, California, United States, 92083-6031
      • Galderma Investigational Site #9930
  • Florida
    • Coral Gables, Florida, United States, 92083-6031
      • Galderma Investigational Site #9929
  • Indiana
    • Indianapolis, Indiana, United States, 46250-2041
      • Galderma Investigational Site #8142
  • Kentucky
    • Louisville, Kentucky, United States, 40217-1444
      • Galderma Investigational Site #8092
  • Michigan
    • Troy, Michigan, United States, 48084-5260
      • Galderma Investigational Site #8155
    • West Bloomfield, Michigan, United States, 48322
      • Galderma Investigational Site #8560
  • New York
    • Brooklyn, New York, United States, 11203-2012
      • Galderma Investigational Site #8242
    • New York, New York, United States, 10032-3729
      • Galderma Investigational Site #9938
  • Oklahoma
    • Norman, Oklahoma, United States, 73069-6301
      • Galderma Investigational Site #8206
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103-4708
      • Galderma Investigational Site #8255
  • Texas
    • Beaumont, Texas, United States, 77706-3061
      • Galderma Investigational Site #9931
    • San Antonio, Texas, United States, 78218-3128
      • Galderma Investigational Site #78218-3128

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: CD14152; Drug: Nemolizumab; 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.; Other Names: CD14152
Experimental: Cohort 1.1: 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 Names: CD14152; Drug: Nemolizumab; 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.; Other Names: CD14152
Experimental: Cohort 1: Participants aged 7-11 year; 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 Names: CD14152; Drug: Nemolizumab; 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.; Other Names: CD14152

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nemolizumab Serum Concentrations	Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).	At Weeks 4, 8, 12, 16, 32 and 52
Apparent Total Body Clearance (Cl/F) of Nemolizumab	CL/F is apparent clearance of the drug from the serum, calculated as the drug dose divided area under the curve from time 0 extrapolated to infinite time [AUC (0-inf)]. Individual nemolizumab.	Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Apparent Volume of Distribution (Vd/F) of Nemolizumab	Vd/F was calculated as dose divided by lambda_z *AUC(0-inf).	Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Absorption Rate Constant (Ka) of Nemolizumab		Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Nemolizumab		Pre-dose at Weeks 4, 8, 12, and 16
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Nemolizumab		Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Apparent Terminal Half-life (t1/2) of Nemolizumab		Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
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)	AE defined as any untoward medical occurrence in clinical study participant administered a medicinal product which does not necessarily have causal relationship with this treatment. TEAEs defined as AEs occurring after first administration of study drug during the study. SAE was any untoward medical occurrence, in view of either Investigator or Sponsor, that resulted in death, was life-threatening, resulted in inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was important medical event. AESI was noteworthy TEAE for study drug that was to be monitored closely and reported promptly. Relatedness to study drug was based on Investigator's discretion. AEs Leading to study treatment withdrawal and AEs Leading to study withdrawal will also be reported.	Baseline through Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 was 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 ranged from 0 to 72 with higher scores representing greater severity of atopic dermatitis.	Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in EASI Score	EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity was 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 ranged from 0 to 72 with higher scores representing greater severity of atopic dermatitis.	Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Number of Participants Achieving 50 Percent (%), 75% or 90% Response From Baseline in EASI (EASI-50, EASI-75 and EASI-90)	EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity was 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 ranged 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 greater than or equal to (>=) 50%, >=75% and >=90% overall improvement in EASI score respectively from baseline to Week 52.	Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Number of Participants With Investigator's Global Assessment (IGA) Success Rate	IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of AD. The Investigator reviewed the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe). Here, higher score indicates severe outcome. Success was defined as an IGA of 0 [Clear] or 1 [Almost clear] and a >=2-points improvement from baseline. Number of participants with IGA success rate was reported for this outcome measure.	Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Baseline in Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD)	BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and reported as a percentage of all major body sections combined. The reported percentage of BSA was combined percentage of all major body sections.	Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) Score	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 were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.	Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percent Change From Baseline in Weekly Average of PP NRS Score	Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.	Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percentage of Participants With an Improvement of >= 4 From Baseline in Weekly Average of PP NRS	Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.	Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in Weekly Average of Average Pruritus NRS Score	Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.	Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percent Change From Baseline in Weekly Average of Average Pruritus NRS Score	Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.	Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in Weekly Average of Sleep Disturbance NRS Score	The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were 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 indicated worse outcome.	Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percent Change From Baseline in Weekly Average of Sleep Disturbance NRS Score	The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were 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 indicated worse outcome.	Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percentage of Participants Receiving Any Rescue Therapy by Rescue Treatment	Percentage of participants receiving any rescue therapy by rescue treatment was reported.	From Baseline up to Week 52
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score	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 ranged from 0 (absent disease) to 103 (severe disease), a higher score indicated severe disease.	Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) For Participants >=4 Years of Age	The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant rated each question ranging from 0 (not at all) to 3 (very much) and score ranged from 0 to 30. A higher total score indicated a poorer quality of life (QoL).	Baseline, Week 16 and Week 52
Change From Baseline in Infants' Dermatology Life Quality Index (iDLQI) Score For Participants Less Than (<) 4 Years of Age	The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant rated each question ranging from 0 (not at all) to 3 (very much) and score ranged from 0 to 30. A higher total score indicated a poorer QoL.	Baseline, Week 16 and Week 52
Change From Baseline in Patient-Oriented Eczema Measure (POEM)	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). A high score indicated poor QOL.	Baseline, Week 16 and Week 52
Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in PP NRS	The relationship between nemolizumab serum concentrations and changes in PP-NRS score was established using population point estimate of IC50, where IC50 is the concentration leading to half of the maximum drug-induced reduction (Imax) in PP NRS.	Baseline up to Week 52
PK/PD Relationship Between Nemolizumab Serum Concentration and Changes in EASI Score	The relationship between nemolizumab serum concentrations and changes in EASI score was established using population point estimate of IC50. Where, IC50 is the concentration leading to half of the maximum drug-induced reduction (Imax) in EASI score.	Baseline up to Week 52
PK/PD Relationship Between Nemolizumab Serum Concentration and Changes in IGA Score	The relationship between nemolizumab serum concentrations and changes in IGA score was established using the population point estimate of the slope parameter.	Baseline up to Week 52
Number of Participants With Positive Anti-Drug Antibody (ADA) for Nemolizumab	ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result.	Baseline, Week 16 and Week 52

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Actual): April 28, 2025
• Study Completion (Actual): April 28, 2025

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; Nemolizumab; CD14152
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; nemolizumab
• Other Study ID Numbers: RD.06.SPR.118126

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No