이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

활동성 특발성 염증성 근병증이 있는 성인에서 에프가르티지모드 피하 제제의 장기 안전성 및 효능을 평가하기 위한 연구 (ALKIVIA+)

2026년 10월 15일 업데이트: argenx

활동성 특발성 염증성 근병증이 있는 18세 이상의 참가자에서 Efgartigimod PH20 SC의 장기 안전성, 내약성 및 효능을 조사하기 위한 연구 ARGX-113-2007의 3상, 단일군, 다기관, 공개 라벨 확장

The main purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with Idiopathic Inflammatory Myopathy (IIM) who previously participated in ARGX-113-2007.

The study consists of a treatment period where participants will receive efgartigimod PH20 SC for up to 51 months. The treatment period will be followed by a treatment-free safety follow-up period of 56 days.

연구 개요

상태

초대로 등록

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

240

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 그루지야
      • Tbilisi, 그루지야, 0160
        • Aversi Clinic
      • Tbilisi, 그루지야, 0180
        • The First Medical Center
      • Tbilisi, 그루지야, 0160
        • LLC MediClub Georgia
      • Tbilisi, 그루지야, 0162
        • New Hospitals
  • 그리스
      • Athens, 그리스, 115 27
        • National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine
      • Athens, 그리스, 115 28
        • National and Kapodistrian University of Athens - Eginition Hospital
      • Athens, 그리스, 12462
        • ATTIKON University General Hospital - Neurology
  • 네덜란드
      • Amsterdam, 네덜란드, 1105 AZ
        • Amsterdam UMC Research BV
  • 대만
      • Taichung, 대만, 402
        • Chung Shan Medical University Hospital
      • Taichung, 대만
        • Taichung Veterans General Hospital
  • 대한민국
      • Seoul, 대한민국, 03080
        • Seoul National University Hospital
  • 덴마크
      • Copenhagen, 덴마크, 2100
        • Copenhagen University Hospital-Rigshospitalet University Hospital
  • 독일
      • Berlin, 독일, 10117
        • Charite Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Rheumatology
      • Hamburg, 독일, 20246
        • Universitaetsklinikum Hamburg-Eppendorf
      • Herne, 독일, 44649
        • Rheumazentrum Ruhrgebiet
      • Mannheim, 독일, 68167
        • Universitatsmedizin Mannheim GmbH
      • Tübingen, 독일, 72076
        • Universitaetsklinikum Tuebingen (UKT)
      • Ulm, 독일, 89081
        • Klinikum der Universitaet Ulm
  • 리투아니아
      • Vilnius, 리투아니아, 08410
        • Santaros University Clinic
  • 멕시코
      • Mexico City, 멕시코, 06700
        • Hospital Angeles Clinica Londres
  • 미국
    • Arizona
      • Phoenix, Arizona, 미국, 85028
        • Neuromuscular Clinical and Research Center - Neurology
    • California
      • Beverly Hills, California, 미국, 90039
        • Attune Health Research, Inc
      • Orange, California, 미국, 92868
        • UCI Health - ALS and Neuromuscular Center - Neurology
      • San Francisco, California, 미국, 94143
        • UCSF Health - ALS and Neurodegenerative Disease Center - Dermatology
    • Connecticut
      • New Haven, Connecticut, 미국, 06520
        • Yale Cancer Center-Yale University School Of Medicine
    • Florida
      • Gainesville, Florida, 미국, 32610
        • UF Health - Rheumatology Medical Specialties Medical Plaza
      • Jacksonville, Florida, 미국, 32224
        • Mayo Clinic - Florida - Neurology
      • Tampa, Florida, 미국, 33616
        • University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
    • Georgia
      • Atlanta, Georgia, 미국, 30322
        • Emory Healthcare - Emory Clinic - Rheumatology
    • Illinois
      • Chicago, Illinois, 미국, 60611
        • Northwestern Medicine - Northwestern Memorial Hospital
    • Maryland
      • Baltimore, Maryland, 미국, 21224-2734
        • John Hopkins Medicine - Johns Hopkins Myositis Center
    • New York
      • Great Neck, New York, 미국, 11021
        • Northwell Health Physician Partners Rheumatology
    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27514
        • University of North Carolina (UNC) School of Medicine
    • Ohio
      • Columbus, Ohio, 미국, 43201
        • The Ohio State University
    • Oregon
      • Portland, Oregon, 미국, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, 미국, 15261
        • University of Pittsburgh Medical Center
    • Texas
      • Austin, Texas, 미국, 78759
        • Austin Neuromuscular Center (National Neuromuscular Research Institute, PLLC)
      • Houston, Texas, 미국, 77030
        • Nerve And Muscle Center Of Texas
  • 벨기에
      • Ghent, 벨기에, 9000
        • AZ Sint-Lucas - Campus Sint-Lucas - Neurology
      • Leuven, 벨기에, 3000
        • Universitair Ziekenhuis Leuven Gasthuisberg Campus
  • 불가리아
      • Plovdiv, 불가리아, 4002
        • Multiprofile hospital for active treatment Kaspela EOOD
      • Plovdiv, 불가리아, 4002
        • Medical Centre Artmed
  • 세르비아
      • Belgrade, 세르비아, 11000
        • Clinical Center of Serbia
      • Belgrade, 세르비아, 11000
        • Institute of Rheumatology
  • 스웨덴
      • Solna, 스웨덴, 17176
        • Karolinska Universitestssjukhus Solna
  • 스페인
      • Barcelona, 스페인, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Madrid, 스페인, 28041
        • Hospital Universitario 12 de Octubre
      • Valencia, 스페인, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia - Neurology
  • 아르헨티나
      • La Plata, 아르헨티나, B1902COS
        • Framingham Centro Medico
      • San Miguel, 아르헨티나, B1663GKT
        • Centro Dermatologico Schejtman
      • San Miguel de Tucumán, 아르헨티나, 4000
        • Centro Medico Privado de Reumatologia
  • 아일랜드
      • Dublin, 아일랜드, D04 T6F4
        • University College Dublin (UCD) - St. Vincent's University Hospital (SVUH)
  • 영국
      • Liverpool, 영국, L9 7AL
        • Aintree University Hospital - Liverpool University Hospitals NHS Foundation Trust
      • London, 영국, NW3 2QG
        • The Royal Free Hospital
      • Salford, 영국, M6 8HD
        • Northern Care Allicance NHS Foundation Trust - Salford Royal - Rheumatology
  • 오스트리아
      • Innsbruck, 오스트리아, 6020
        • Tirol Kliniken - A.o. Landeskrankenhaus Innsbruck - Neurology
  • 이탈리아
      • Bari, 이탈리아, 70124
        • Azienda Ospedaliero Universitaria Consorziale Policlinico
      • Milan, 이탈리아, 20132
        • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital
      • Pisa, 이탈리아, 56126
        • Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara - Rheumatology
      • Roma, 이탈리아, 00189
        • Ospedale Sant'Andrea Hospital
      • Roma, 이탈리아, 168
        • Fondazione Policlinico Universitario Agostino Gemelli - Neurology
      • Rozzano, 이탈리아, 20089
        • IRCCS Istituto Clinico Humanitas
      • Udine, 이탈리아, 33100
        • Azienda sanitaria universitaria Friuli Centrale - ASUFC
  • 일본
      • Bunkyō City, 일본, 113-8431
        • Juntendo University Hospital
      • Bunkyō City, 일본, 113-8655
        • The University of Tokyo Hospital
      • Nagoya, 일본, 457-8510
        • Japan Community Healthcare Organization Chukyo Hospital
      • Tokyo, 일본, 113-8519
        • Institute of Science Tokyo Hospital
      • Wakayama, 일본, 641-8510
        • Wakayama Medical University Hospital
      • Yamaguchi, 일본, 755-8505
        • Yamaguchi University Hospital
  • 중국
      • Beijing, 중국, 100730
        • Peking Union Medical College Hospital
      • Beijing, 중국, 100191
        • Peking University Third Hospital
      • Chengdu, 중국, 610072
        • Sichuan Provincial Academy of Medical Sciences and Sichuan Provincial People's Hospital
      • Shanghai, 중국, 200040
        • Huashan Hospital Affiliated to Fudan University
      • Shanghai, 중국, 200001
        • Shanghai Jiao Tong University School of Medicine - Renji Hospital - Shanghai Institute of Digestive Disease (SIDD)
      • Shenyang, 중국, 110001
        • China Medical University (CMU) - First Affiliated Hospital
      • Zhengzhou, 중국, 450052
        • First Affiliated Hospital (Henan Medical University - First Affiliated Hospital)-Zhengzhou University
    • Guangdong
      • Guangzhou, Guangdong, 중국, 510515
        • Nanfang Hospital, Southern Medical University
    • Jingsu
      • Nanjing, Jingsu, 중국, 210000
        • Nanjing University Medical School - Taikang Xianlin Drum Tower Hospital (Nanjing Drum Tower Hospital)
  • 체코
      • Prague, 체코, 12850
        • Revmatologicky Ustav
  • 키프로스
      • Nicosia, 키프로스, 2371
        • Cyprus Institute of Neurology and Genetics
  • 태국
      • Bangkok, 태국, 10400
        • Phramongkutklao Hospital
      • Bangkok, 태국, 10330
        • King Chulalongkorn Memorial Hospital - Neurology
      • Bangkok, 태국, 10700
        • Siriraj Hospital, Mahidol University of Internal medicine
      • Bangkok, 태국, 10400
        • Ramathibodi hospital
      • Khon Kaen, 태국, 40002
        • Faculty Of Medicine, Khon Kaen University
  • 페루
      • Arequipa, 페루, 4000
        • Clinica San Juan de Dios - sede Arequipa - Rheumatology
      • Lima, 페루, 33
        • Investigaciones Clinicas S.A.C.
      • Lima, 페루, 27
        • Instituto Peruano Del Hueso Y La Articulacion Sac-Privado-Lima,Centro De Investigacion Iphar
  • 포르투갈
      • Porto, 포르투갈, 4099-001
        • Centro Hospitalar do Porto - Hospital Santo Antonio
  • 폴란드
      • Lodz, 폴란드, 90-549
        • USK-WAM Centralny Szpital Weteranow - Szpital Kniniczny ul. Zeromskiego 113 - Rheumatology
      • Szczecin, 폴란드, 71-252
        • Centrum Wsparcia Badan Klinicznych Pomorskiego Uniwersytetu Medycznego w Szczecinie (CWBK PUM) - Rheumatology
  • 프랑스
      • Paris, 프랑스, 75013
        • Reference Center Neuro-Muscular Diseases - CHU Paris Group Hospitalier La Pitie Salpetriere-Charles Foix

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Has completed trial ARGX-113-2007
  • Being capable of providing signed informed consent and complying with protocol requirements
  • Agrees to use contraceptive measures consistent with local regulations and women of childbearing potential must have a negative urine pregnancy test at baseline before receiving the study drug

Exclusion Criteria:

  • Intention to have major surgery during the study period or any other medical condition that has arisen since enrollment in study ARGX-113-2007, that in the investigator's opinion, would confound the results of the study or put the participant at undue risk
  • Known hypersensitivity reaction to the study drug or 1 of its excipients
  • Development of any malignancy, either new or recurrent, other than basal cell carcinoma of the skin, regardless of relatedness

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: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Efgartigimod PH20 SC

Participants receiving efgartigimod PH20 subcutaneously
생물학적: Efgartigimod PH20 SC

Subcutaneous injection of Efgartigimod PH20 given by vials or prefilled syringe (PFS)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of AEs, SAEs and AESIs over time
기간: Up to 53 months

AE : adverse event ; SAE : serious adverse event ; AESI : adverse event of special interest.
Up to 53 months

2차 결과 측정

결과 측정
측정값 설명
기간
시간 경과에 따른 프레드니손 용량 감소(월 평균 용량)
기간: 최대 51개월
최대 51개월
기준선 대비 혈청 내 총 IgG 수치의 시간 경과에 따른 백분율 변화
기간: 최대 53개월
최대 53개월
2주마다 투여하는 기간
기간: 최대 51개월
최대 51개월
C-GTI comprising the AIS over time
기간: Up to 51 months

The Composite Glucocorticoid Toxicity Index (C-GTI) serves as a primary instrument to capture toxicities likely caused by glucocorticoid exposure and enables monitoring of long-term tolerability of glucocorticoids during prolonged use. The Aggregate Improvement Score (AIS) is an analytical scores generated from the weighted C-GTI. The AIS can be used to assess whether a new therapy is effective in reducing glucocorticoid toxicity over time; higher AIS scores are associated with less toxicity.
Up to 51 months
C-GTI comprising the CWS over time
기간: Up to 51 months

The Composite Glucocorticoid Toxicity Index (C-GTI) serves as a primary instrument to capture toxicities likely caused by glucocorticoid exposure and enables monitoring of long-term tolerability of glucocorticoids during prolonged use. The Cumulative Worsening Score (CWS) is an analytical score generated from the weighted C-GTI. The CWS is designed to assess cumulative glucocorticoid toxicity; higher scores indicate increased steroid toxicity.
Up to 51 months
C-GTI comprising the GTI-MD over time
기간: Up to 51 months

The Composite Glucocorticoid Toxicity Index (C-GTI) serves as a primary instrument to capture toxicities likely caused by glucocorticoid exposure and enables monitoring of long-term tolerability of glucocorticoids during prolonged use. The Glucocorticoid Toxicity Index-Metabolic Domains (GTI-MD) is an abbreviated GTI version limited to the 4 metabolic domains. A GTI-MD score of 0 indicates a low likelihood of toxicity in the assessed metabolic domains.
Up to 51 months
TIS over time
기간: Up to 51 months

The total improvement score (TIS) assesses minimal, moderate, and major clinical response, and it is assessed using the ACR/EULAR criteria. The total score varies between 0 and 100, with higher scores indicating greater improvement.
Up to 51 months
Proportion of TIS responders (minimal, moderate, major) over time
기간: Up to 51 months

The total improvement score (TIS) assesses minimal, moderate, and major clinical response, and it is assessed using the ACR/EULAR criteria. The total score varies between 0 and 100, with higher scores indicating greater improvement
Up to 51 months
Individual CSMs of the TIS over time
기간: Up to 51 months

The total improvement score (TIS) assesses minimal, moderate, and major clinical response, and it is assessed using the ACR/EULAR criteria. The ACR/EULAR criteria calculate TIS using the 6 core set measure (CSMs): MDGA, PGA, MMT8, HAQ-DI, muscle enzymes, and extramuscular global assessment (assessed by the MDAAT).
Up to 51 months
Percentage of participants with clinically inactive disease
기간: Up to 51 months

Clinically inactive disease is defined as no evidence of disease activity, based on an Physician Global Assessment of Disease Activity (MDGA) and Extramuscular Global Assessment of the Myositis Disease Activity Assessment Tool (MDAAT) of 0 and normal creatine kinase (CK) values for at least 12 weeks (at week 28 and every 24 weeks thereafter).
Up to 51 months
Percentage of participants with remission during the study
기간: Up to 51 months

Remission is defined as a clinically inactive disease for at least 24 weeks
Up to 51 months
PGI-S over time
기간: Up to 51 months

The Patient Global Impression of Severity (PGI-S) asks participants to rate the severity of their disease symptoms over the past 7 days on a 4-point Likert scale, where scores range from "no symptoms" to "severe."
Up to 51 months
CGI-S over time
기간: Up to 51 months

The Clinical Global Impression of Severity (CGI-S) asks the physician to rate the severity of the participant's disease on a 4-point Likert scale, where scores range from "no activity" to "severe".
Up to 51 months
Physical Functioning subscale and Physical Component Summary scores of the SF-36v2 over time
기간: Up to 51 months

The 36-Item Short Form Survey version 2 (SF-36v2) is a 36-item scale constructed to survey health-related quality of life in 8 domains.
Up to 51 months
EQ-5D-5L utilities over time
기간: Up to 51 months

The EQ-5D-5L questionnaire is a standardized test recognized by many health authorities as a generic measure of health status for clinical and economic appraisal. The descriptive system comprises 5 dimensions, each having 5 levels ranging from "No problem" to "Extreme problem".
Up to 51 months
EQ-5D-5L VAS over time
기간: Up to 51 months

The EQ-5D-5L questionnaire is a standardized test recognized by many health authorities as a generic measure of health status for clinical and economic appraisal. A visual analog scale (VAS) is included in the EQ-5D-5L, where participants will mark their health status from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Up to 51 months
Incidence of ADA against efgartigimod (serum levels) over time
기간: Up to 53 months

ADA : anti-drug antibodies.
Up to 53 months
Proportion of participants achieving sustained low disease activity while on IMP, over time
기간: Up to 51 months

Sustained low disease activity is defined as a CGI-S score of "mild" or "no activity" and a PGI-S score of "mild" or "no symptoms" for at least 12 weeks.
Up to 51 months
Proportion of participants with low disease activity over time, while on IMP
기간: Up to 51 months

Low disease activity is defined as a CGI-S score of "mild" or "no activity" and a PGI-S score of "mild" or "no symptoms"
Up to 51 months
Proportion of participants with low disease activity who continue dosing every 2 weeks at week 52 and every 24 weeks thereafter
기간: Up to 51 months

Low disease activity is defined as a CGI-S score of "mild" or "no activity" and a PGI-S score of "mild" or "no symptoms"
Up to 51 months
Proportion of participants who have marked worsening during the period of dosing every 2 weeks
기간: Up to 51 months

Marked worsening is defined as a CGI-S score of "moderate" or "severe" and a PGI-S score of "moderate" or "severe"
Up to 51 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

argenx

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)

2023년 9월 12일

기본 완료 (추정된)

2028년 9월 1일

연구 완료 (추정된)

2028년 9월 1일

연구 등록 날짜

최초 제출

2023년 7월 28일

QC 기준을 충족하는 최초 제출

2023년 7월 28일

처음 게시됨 (실제)

2023년 8월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 15일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ARGX-113-2011
  • 2022-502851-79-00 (씨티스)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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