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중등도에서 중증 아토피 피부염 환자에 대한 Nemolizumab의 약동학, 안전성 및 효능

2026년 6월 1일 업데이트: Galderma R&D

중등도에서 중증 아토피 피부염이 있는 소아 피험자(2~11세)에서 Nemolizumab(CD14152)의 약동학, 안전성 및 효능을 평가하기 위한 다기관, 공개 라벨, 단일 그룹 임상 시험

이 연구의 목적은 중등도에서 중증의 아토피성 피부염(AD)이 있는 소아 참가자에서 nemolizumab의 약동학(PK), 효능 및 안전성을 평가하는 것입니다.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

109

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

2년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  • 스크리닝 방문 전 2-6세 참가자의 경우 최소 6개월, 7-11세 참가자의 경우 최소 1년 동안 문서화되고 미국 피부과학회 합의 기준에 따라 확인된 만성 AD 스크리닝 방문
  • 스크리닝 및 기준선 방문 모두에서 EASI 점수 >=16
  • 스크리닝 및 기준선 방문 모두에서 IGA 점수 >=3
  • 스크리닝 및 기준선 방문 모두에서 AD 관련 >= BSA의 10%
  • 스크리닝 및 기준선 방문 모두에서 최소 4.0의 피크(최대) PP NRS 점수
  • 스크리닝 방문부터 연구 기간 동안 매일 그리고 필요에 따라 충분히 보습제를 바르는 데 동의합니다. 심사원이 적절하다고 판단한 바에 따라 스크리닝 방문부터 연구 기간 동안 승인된 국소 코르티코스테로이드(TCS)를 적용하는 데 동의합니다.
  • 임상 시험 프로토콜의 모든 시간 약속 및 절차 요구 사항을 준수할 의지와 능력이 있는 참가자 및 간병인
  • 다른 프로토콜 정의 포함 기준이 적용될 수 있음

제외 기준:

  • 체중 10킬로그램(kg) 미만
  • 양육 중인 아동: 법원, 정부 또는 정부 기관에 의해 기관, 조직, 기관 또는 단체의 통제 또는 보호 아래 있으며, 법률 또는 규정에 의해 부여된 권한에 따라 행동하는 아동
  • 현재 만성 기관지염 병력이 있는 참가자
  • 도입 기간 동안 AD에 대한 구조 요법이 필요하거나 기준선 방문 후 2주 이내에 구조 요법이 필요할 것으로 예상되는 경우
  • B형 간염 표면 항원(HBsAg) 또는 B형 간염 코어 항체(HBcAb), C형 간염(HCV) 항체에 대한 양성 확증 검사(예: 중합효소 연쇄 반응[PCR]) 또는 인간 면역결핍 바이러스(HIV)에 대한 양성 혈청 결과 스크리닝 방문 시 항체
  • 림프증식성 질환의 병력, 면역글로불린 제품에 대한 과민증(아나필락시스 포함) 및 저역가 또는 중역가 국소 코르티코스테로이드에 대한 과민증
  • 알려진 또는 의심되는 면역억제
  • 임상 시험 중에 금지된 약물 사용을 자제하지 않으려는 참가자.
  • 다른 프로토콜 정의 제외 기준이 적용될 수 있음

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 코호트 2: 2-6세 참가자
2~6세 참가자는 52주 동안 네몰리주맙을 투여받게 됩니다.
의약품: 네몰리주맙
참가자는 52주 동안 4주마다(Q4W) 10, 20 또는 30mg의 nemolizumab을 피하(SC) 주사하고 체중을 기준으로 1일에 20, 40 또는 60mg의 부하 용량을 투여합니다.
다른 이름들:
  • CD14152
의약품: 네몰리주맙
참가자는 52주 동안 5, 10 또는 15mg nemolizumab, Q4W를 피하주사로 투여받게 되며 체중에 따라 1일차에 10, 20 또는 30mg의 부하 용량을 투여하게 됩니다.
다른 이름들:
  • CD14152
실험적: 코호트 1.1: 7-11세 참가자
7~11세 참가자는 52주 동안 네몰리주맙을 투여받게 됩니다.
의약품: 네몰리주맙
참가자는 52주 동안 4주마다(Q4W) 10, 20 또는 30mg의 nemolizumab을 피하(SC) 주사하고 체중을 기준으로 1일에 20, 40 또는 60mg의 부하 용량을 투여합니다.
다른 이름들:
  • CD14152
의약품: 네몰리주맙
참가자는 52주 동안 5, 10 또는 15mg nemolizumab, Q4W를 피하주사로 투여받게 되며 체중에 따라 1일차에 10, 20 또는 30mg의 부하 용량을 투여하게 됩니다.
다른 이름들:
  • CD14152
실험적: 코호트 1 : 7-11 세의 참가자
7-11 세의 참가자는 52 주 동안 네밀리 주맙을 받게됩니다.
의약품: 네몰리주맙
참가자는 52주 동안 4주마다(Q4W) 10, 20 또는 30mg의 nemolizumab을 피하(SC) 주사하고 체중을 기준으로 1일에 20, 40 또는 60mg의 부하 용량을 투여합니다.
다른 이름들:
  • CD14152
의약품: 네몰리주맙
참가자는 52주 동안 5, 10 또는 15mg nemolizumab, Q4W를 피하주사로 투여받게 되며 체중에 따라 1일차에 10, 20 또는 30mg의 부하 용량을 투여하게 됩니다.
다른 이름들:
  • CD14152

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Nemolizumab Serum Concentrations
기간: At Weeks 4, 8, 12, 16, 32 and 52
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
기간: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
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
기간: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
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
기간: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Nemolizumab
기간: Pre-dose at Weeks 4, 8, 12, and 16
Pre-dose at Weeks 4, 8, 12, and 16
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Nemolizumab
기간: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Apparent Terminal Half-life (t1/2) of Nemolizumab
기간: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
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)
기간: Baseline through Week 52
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

2차 결과 측정

결과 측정
측정값 설명
기간
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Each Visit up to Week 52
기간: Baseline, Weeks 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 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
기간: Baseline, Weeks 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 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)
기간: Baseline, Weeks 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 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
기간: Baseline, Weeks 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 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)
기간: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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
기간: Baseline, Weeks 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 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
기간: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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
기간: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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
기간: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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
기간: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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
기간: Baseline, Weeks 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 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
기간: Baseline, Weeks 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 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
기간: From Baseline up to Week 52
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
기간: Baseline, Weeks 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 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
기간: 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 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
기간: 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 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)
기간: 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). 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
기간: Baseline up to Week 52
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
기간: Baseline up to Week 52
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
기간: Baseline up to Week 52
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
기간: Baseline, Week 16 and Week 52
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

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스폰서

Galderma R&D

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 6월 24일

기본 완료 (실제)

2025년 4월 28일

연구 완료 (실제)

2025년 4월 28일

연구 등록 날짜

최초 제출

2021년 6월 4일

QC 기준을 충족하는 최초 제출

2021년 6월 4일

처음 게시됨 (실제)

2021년 6월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 1일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RD.06.SPR.118126

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

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