중등도 내지 중증 궤양성 대장염 또는 크론병에서 TEV-48574의 장기적 효과를 평가하기 위한 연구
완료한 중등도에서 중증 궤양성 대장염 또는 크론병이 있는 성인 환자에서 TEV-48574의 장기 약동학, 효능, 안전성 및 내약성을 결정하기 위한 24주 2b상 장기 연장, 무작위배정, 이중맹검 연구 용량 범위 연구(RELIEVE UCCD LTE)의 주요 단계
The primary objective of the study is to evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 4 weeks (Q4W) in adult participants with inflammatory bowel disease (IBD).
Secondary objectives of the study are to:
- evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
- evaluate the safety and tolerability of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
- evaluate the immunogenicity of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
The total duration for a participant in the double-blind period only is 66 weeks; and for a participant in the open-label extension (OLE) period, up to an additional 268 weeks.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Tbilisi, 그루지야, 0119
- Israeli - Georgian Medical Research Clinic Healthycore LLC
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Tbilisi, 그루지야, 0180
- Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
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Lorenskog, 노르웨이, 1478
- Akershus University Hospital
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Kiel, 독일, 24105
- University Hospital Schleswig-Holstein
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Tübingen, 독일, 72076
- University Hospital Tuebingen
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Ulm, 독일, 89081
- University Hospital Ulm
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Wipperfürth, 독일, 51688
- Group Practice Jakobeit
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California
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San Diego, California, 미국, 92103
- Clinical Applications Laboratories Inc
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Florida
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Kissimmee, Florida, 미국, 34741
- I.H.S. Health
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Orlando, Florida, 미국, 32803
- Endoscopic Research, Inc.
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Pinellas Park, Florida, 미국, 33781
- Gastro Florida
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Illinois
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Gurnee, Illinois, 미국, 60031
- Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee
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Indiana
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New Albany, Indiana, 미국, 47150
- Gastroenterology Health Partners, PLLC
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Kansas
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Kansas City, Kansas, 미국, 66160
- University of Kansas Medical Center
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Kentucky
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Louisville, Kentucky, 미국, 40218
- Gastroenterology Health Partners, PLLC - Central Louisville
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Missouri
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Liberty, Missouri, 미국, 64068
- BVL Clinical Research
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St Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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Nevada
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Las Vegas, Nevada, 미국, 89128.
- Vector Clinical Trials
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Ohio
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Beavercreek, Ohio, 미국, 45440
- Dayton Gastroenterology, LLC - Beavercreek
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Texas
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Harlingen, Texas, 미국, 78550
- Texas Digestive Specialists
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Katy, Texas, 미국, 77494
- Gastro Health & Nutrition - Katy
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San Antonio, Texas, 미국, 78229
- Gastroenterology Research of San Antonio LLC
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Southlake, Texas, 미국, 76092
- Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake
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Tyler, Texas, 미국, 75701
- Tyler Research Institute, LLC
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Utah
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Salt Lake City, Utah, 미국, 84124
- Care Access
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Gorna Oryahovitsa, 불가리아, 5100
- Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
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Sofia, 불가리아, 1618
- 20th Diagnostic Consultancy Center, Sofia
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Sofia, 불가리아, 1784
- University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic, Sofia
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Huelva, 스페인, 21005
- Juan Ramon Jimenez Hospital
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Santiago de Compostela, 스페인, 15702
- Gaias Santiago Clinic
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Valencia, 스페인, 46026
- University and Polytechnic Hospital La Fe
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Bardejov, 슬로바키아, 085 01
- ALIAN, s.r.o.
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Bratislava, 슬로바키아, 811 09
- Cliniq, s.r.o.
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Košice, 슬로바키아, 040 13
- Endomed, s.r.o.
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Prešov, 슬로바키아, 080 01
- GASTRO I, s.r.o.
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Prešov, 슬로바키아, 080 01
- Gastro LM s.r.o.
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London, 영국, SE1 9RT
- Guy's Hospital
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Vienna, 오스트리아, 1090
- Medical University Vienna
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Chernivtsi, 우크라이나, 58002
- Regional Communal Noncommercial Enterprise: Chernivtsi Regional Clinical Hospital, Department of Gastroenterology
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Ivano-Frankivsk, 우크라이나, 76008
- Communal Non-Profit Enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council
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Lviv, 우크라이나, 79000
- University Hospital branch of State Non-Profit Enterprise Danylo Halytsky Lviv National Medical University
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Lviv, 우크라이나, 79010
- Municipal Non-Profit Enterprise Lviv Territorial Medical Union Multidisciplinary Clinical Hospital of Emergency and Intensive Ca
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Lviv, 우크라이나, 79010
- University Hospital of the State Non-Profit Company Danylo Halytsky Lviv National Medical University, Clinic of Surgery, Proctol
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Uzhhorod, 우크라이나, 88018
- Public Non-Profit Enterprise Andrii Novak Zakarpattia Regional Clinical Hospital under Zakarpattia Regional Council
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Vinnytsia, 우크라이나, 21018
- Municipal Non-Profit Enterprise Vinnytsia Regional Clinical Hospital named after M.I. Pirogov Vinnytsia Regional Council, Depart
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Vinnytsia, 우크라이나, 21018
- National Pirogov Memorial Medical University, University Clinic of Vinnytsia National Pirogov Memorial Medical University (Treat
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Afula, 이스라엘, 1834111
- HaEmek Medical Center
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Beersheba, 이스라엘, 8410101
- Soroka University Medical Center
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Milan, 이탈리아, 20132
- Hospital San Raffaele, IRCCS
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Milan, 이탈리아, 20157
- ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, Polo University
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Rozzano, 이탈리아, 20089
- Clinical Institute Humanitas, IRCCS
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Kashiwa, 일본, 277-0871
- Kokikai Tsujinaka Hospital Kashiwanoha, Department of Gastroenterology
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Minato, 일본, 108-8642
- Kitasato University Kitasato Institute Hospital
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Sakura, 일본, 285-8741
- Toho University Sakura Medical Center, Department of Gastroenterology
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Shinjuku, 일본, 169-0073
- Tokyo Yamate Medical Center, Department of Gastroenterology
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Toyama, 일본, 930-8550
- Toyama Prefectural Central Hospital, Department of Internal Medicine, Gastroenterology
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Brno, 체코, 615 00
- Military Hospital Brno
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Klatovy, 체코, 339 01
- GASTRO JeKa s.r.o.
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Slaný, 체코, 274 01
- Hospital Slany
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Bydgoszcz, 폴란드, 85-794
- CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska
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Częstochowa, 폴란드, 42-202
- Synexus Polska Sp. Z o.o. Branch in Czestochowa
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Elblag, 폴란드, 82-300
- St. John Paul 2nd Municipal Hospital in Elblag, Department of Internal Diseases
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Gdansk, 폴란드, 80-382
- Synexus Polska Sp. z o.o. Branch in Gdansk
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Katowice, 폴란드, 40-040
- Synexus Polska Sp. z o.o. Branch in Katowice
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Krakow, 폴란드, 31-506
- Topolowa Medicenter
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Krakow, 폴란드, 31-156
- Landa Specialist Doctor's Offices
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Krakow, 폴란드, 30-363
- PLEJADY Medical Centre
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Kłodzko, 폴란드, 57-300
- GLOBE Clinical Research
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Lodz, 폴란드, 90-752
- IP Clinic
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Nowy Targ, 폴란드, 34-400
- Non-Public Healthcare Facility Allmedica Clinical Trials
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Poznan, 폴란드, 60-702
- Synexus Polska Sp. z o.o. Branch in Poznan
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Poznan, 폴란드, 54-144
- EMC Medical Institute Joint Stock Company, Certus Private Healthcare Facility Hospital No. 1
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Poznan, 폴란드, 54-144
- EMC Medical Institute Joint Stock Company, Penta Hospitals Clinics, Wroclaw Wejherowska
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Poznan, 폴란드, 60-529
- SOLUMED Medical Center
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Sopot, 폴란드, 81-756
- Endoskopia Sp. z o.o. (LLC)
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Staszów, 폴란드, 28-200
- New health-CK, Kieltucki and partners g.p.
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Szczecin, 폴란드, 71-685
- SONOMED
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Szczecin, 폴란드, 71-434
- TWOJA PRZYCHODNIA Medical Centre of Szczecin
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Torun, 폴란드, 87-100
- Torun Gastrology Centre Gastromed
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Wadowice, 폴란드, 34-100
- NZOZ Formed
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Warsaw, 폴란드, 02-672
- Synexus Polska Sp. z o.o. Branch in Warsaw
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Warsaw, 폴란드, 04-501
- WIP Warsaw IBD Point Profesor Kierkus
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Warsaw, 폴란드, 00-189
- MDM Healthcare Centre
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Warsaw, 폴란드, 02-786
- WSD Medi
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Wroclaw, 폴란드, 52-416
- Medical Centre Oporow
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Wroclaw, 폴란드, 53-673
- FutureMeds Wroclaw
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Wroclaw, 폴란드, 53-149
- VISTAMED
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Wroclaw, 폴란드, 53-611
- Melita Medical Medical Center
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Zamość, 폴란드, 22-400
- ETG Zamosc
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Łęczna, 폴란드, 21-010
- Independent Public Healthcare Center in Leczna
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Budapest, 헝가리, H-1033
- Clinexpert Ltd. Budapest
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Budapest, 헝가리, 1085
- Semmelweis University, Department of Internal Medicine and Hematology
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Vác, 헝가리, H-2600
- Javorszky Odon Hospital Vac
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Maintenance Period- Participants who achieved clinical response and/or clinical remission at week 14 of TV48574-IMM-20036 (the 14-week DRF study) or in the re-induction period of this study.
- Re-induction- Participants who did not achieve clinical response and/or clinical remission at week 14 of the TV48574-IMM-20036 DRF study
NOTE- Additional criteria may apply, please contact the investigator for more information
Exclusion Criteria:
- Participants who discontinued the TV48574-IMM-20036 study before scheduled week 14 visit (any reason including lack of efficacy, safety, or personal reasons)
- Participant has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the participant at increased risk during the study as judged by the investigator and/or the clinical study physician.
- Participant anticipates requiring major surgery during this study.
- Participant is currently pregnant or lactating or is planning to become pregnant or to lactate during the study or for at least 50 days after administration of the last dose of IMP in case of early termination. Any woman becoming pregnant during the study will be withdrawn from the study.
NOTE- Additional criteria apply, please contact the investigator for more information
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: TEV-48574 Dose Regimen A for Ulcerative Colitis (UC)
Administered by subcutaneous infusion for participants with UC |
Subcutaneous (sc) administration using a commercial sc infusion system
다른 이름들:
|
|
실험적: TEV-48574 Dose Regimen A for Crohn's Disease (CD)
Administered by subcutaneous infusion for participants with CD |
Subcutaneous (sc) administration using a commercial sc infusion system
다른 이름들:
|
|
실험적: TEV-48574 Dose Regimen B for Ulcerative Colitis (UC)
Administered by subcutaneous infusion for participants with UC |
Subcutaneous (sc) administration using a commercial sc infusion system
다른 이름들:
|
|
실험적: TEV-48574 Dose Regimen B for Crohn's Disease (CD)
Administered by subcutaneous infusion for participants with CD |
Subcutaneous (sc) administration using a commercial sc infusion system
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of participants with moderate to severe ulcerative colitis (UC) who show clinical remission as defined by the Mayo score
기간: Week 44
|
Clinical remission based on modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points, which is defined by:
|
Week 44
|
|
Number of participants with moderate to severe Crohn's disease (CD) who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease
기간: Week 44
|
Endoscopic response, defined as a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 50% from DRF study baseline at week 44 in participants with CD |
Week 44
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
중화 ADA가 있는 ADA 양성 참가자 수
기간: 0주차, 4주차, 8주차, 16주차, 28주차, 44주차, 48주차
|
0주차, 4주차, 8주차, 16주차, 28주차, 44주차, 48주차
|
|
|
이중맹검 기간 중 부작용으로 인해 임상시험용 의약품(IMP) 복용을 중단한 참가자 수
기간: 48주차까지
|
48주차까지
|
|
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오픈 라벨(OL) 기간 동안 부작용으로 인해 시험용 의약품(IMP) 복용을 중단한 참가자 수
기간: OL기간 개시 후 5년까지
|
OL기간 개시 후 5년까지
|
|
|
긴급 항약물항체(ADA) 치료를 받은 참가자 수
기간: 0주차, 4주차, 8주차, 16주차, 28주차, 44주차, 48주차
|
0주차, 4주차, 8주차, 16주차, 28주차, 44주차, 48주차
|
|
|
Number of participants with moderate to severe UC with a clinical response as defined by Mayo score
기간: Week 44
|
Clinical response at week 44, defined as a decrease from baseline in the modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of at least 2 points AND at least a 30% reduction from DRF baseline with either a decrease in rectal bleeding subscore of at least 1 or an absolute rectal bleeding subscore of less than or equal to 1 |
Week 44
|
|
Number of participants with moderate to severe UC with Endoscopic improvement as defined by Mayo score
기간: Week 44
|
Endoscopic improvement defined as a Mayo endoscopic subscore of 0 or 1 |
Week 44
|
|
Number of participants with moderate to severe UC in Endoscopic remission as defined by Mayo score
기간: Week 44
|
Endoscopic remission defined as a Mayo endoscopic subscore of 0 |
Week 44
|
|
Number of participants with moderate to severe UC with Corticosteroid-free clinical remission based on the modified Mayo score
기간: Week 44
|
Defined by clinical remission and corticosteroid-free for ≥12 weeks preceding week 44 |
Week 44
|
|
Number of participants with moderate to severe CD with a clinical response based on Crohn's Disease Activity Index
기간: Week 44
|
Clinical response defined as a ≥100-point decrease from DRF baseline Crohn's Disease Activity Index (CDAI) score |
Week 44
|
|
Number of participants with moderate to severe CD in clinical remission as defined by CDAI score
기간: Week 44
|
Clinical remission defined as a CDAI score less than 150 |
Week 44
|
|
Number of participants with moderate to severe CD with Corticosteroid-free endoscopic response based on SES-CD
기간: Week 44
|
Defined by endoscopic response and corticosteroid-free for ≥12 weeks preceding week 44 |
Week 44
|
|
Number of participants with moderate to severe CD with Corticosteroid-free clinical remission based on CDAI
기간: Week 44
|
Defined by a CDAI score of <150 points and corticosteroid-free for ≥12 weeks preceding week 44 |
Week 44
|
|
Number of participants who experience adverse events in the double-blind period
기간: Up to Week 48
|
Adverse events can include any of the following clinically significant changes in clinical laboratory test results (serum chemistry, hematology, and urinalysis), vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate), 12-lead electrocardiogram (ECG), and injection site reactions. |
Up to Week 48
|
|
Number of participants who experience adverse events in the open-label (OL) period
기간: Up to 5 years after start of OL period
|
Adverse events can include any of the following clinically significant changes in clinical laboratory test results (serum chemistry, hematology, and urinalysis), vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate), 12-lead electrocardiogram (ECG), and injection site reactions. |
Up to 5 years after start of OL period
|
공동 작업자 및 조사자
협력자
수사관
- 연구 책임자: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D LLC
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- TV48574-IMM-20038
- 2022-002593-89 (레지스트리 식별자: EudraCT (EU))
- 2024-515027-11-00 (레지스트리 식별자: CTIS (EU))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .