적당히 활발한 크론 병을 가진 참가자의 Duvakitug의 효능과 안전성을 조사하기위한 유지 보수 연구 (STARSCAPE-2)
다기관, 다국적, 무작위, 이중 맹검, 위약 대조 3 단계, 유지 보수 연구, 적당히 활동적인 크론 병의 참가자에서 Duvakitug의 효능과 안전성을 평가하기위한 유지 보수 연구
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include:
The study duration may be up to 286 weeks including:
- 40-week Pivotal Maintenance Sub-Study
- 240-week Open-Label Extension (OLE) Sub-Study
- 45-day Follow-Up visit
Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.
The treatment duration may be up to 280 weeks including:
- 40 weeks in the Pivotal Maintenance Sub-Study
- 240 weeks in OLE Sub-Study
The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 3단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Trial Transparency email recommended (Toll free for US & Canada)
- 전화번호: option 6 800-633-1610
- 이메일: Contact-US@sanofi.com
연구 장소
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Tbilisi, 그루지야, 159
- 모병
- Investigational Site Number : 2680003
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Tbilisi, 그루지야, 180
- 모병
- Investigational Site Number : 2680002
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Tbilisi, 그루지야, 180
- 모병
- Investigational Site Number : 2680004
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Tbilisi, 그루지야, 102
- 모병
- Investigational Site Number : 2680006
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Tbilisi, 그루지야, 144
- 모병
- Investigational Site Number : 2680008
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Tbilisi, 그루지야, 160
- 모병
- Investigational Site Number : 2680005
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Cape Town, 남아프리카, 7405
- 모병
- Investigational Site Number : 7100002
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Durban, 남아프리카, 3610
- 모병
- Investigational Site Number : 7100004
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Kempton Park, 남아프리카, 1619
- 모병
- Investigational Site Number : 7100001
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Tilburg, 네덜란드, 5022 GC
- 모병
- Investigational Site Number : 5280003
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Lower Hutt, 뉴질랜드, 5010
- 모병
- Investigational Site Number : 5540003
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Changhua County, 대만, 500209
- 모병
- Investigational Site Number : 1580005
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Busan, 대한민국, 48108
- 모병
- Investigational Site Number : 4100008
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Gwangju, 대한민국, 61453
- 모병
- Investigational Site Number : 4100007
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Seoul, 대한민국, 6351
- 모병
- Investigational Site Number : 4100006
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Seoul, 대한민국, 6973
- 모병
- Investigational Site Number : 4100002
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Baden-Wurttemberg
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Ulm, Baden-Wurttemberg, 독일, 89081
- 모병
- Investigational Site Number : 2760005
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Saxony
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Leipzig, Saxony, 독일, 4103
- 모병
- Investigational Site Number : 2760015
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, 독일, 24105
- 모병
- Investigational Site Number : 2760001
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Kaunas, 리투아니아, LT-50161
- 모병
- Investigational Site Number : 4400001
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Chisinau, 몰도바, MD-2025
- 모병
- Investigational Site Number : 4980003
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Chisinau, 몰도바, MD-2025
- 모병
- Investigational Site Number : 4980002
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Chisinau, 몰도바, MD-2068
- 모병
- Investigational Site Number : 4980004
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Colorado
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Colorado Springs, Colorado, 미국, 80907
- 모병
- Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
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Florida
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Kissimmee, Florida, 미국, 34741
- 모병
- Clinical Research of Osceola-Site Number: 8400013
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Miami, Florida, 미국, 33125
- 모병
- Columbus Clinical Services LLc-Site Number: 8400038
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Miami, Florida, 미국, 33175
- 모병
- Bioresearch Partner-Kendale Lakes-Site Number: 8400053
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Orlando, Florida, 미국, 32806
- 모병
- Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084
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Tampa, Florida, 미국, 33607
- 모병
- NMC Research LLC-Site Number: 8400033
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Illinois
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Gurnee, Illinois, 미국, 60031
- 모병
- Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee-Site Number: 8400049
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Indiana
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New Albany, Indiana, 미국, 47150
- 모병
- Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100
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Louisiana
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Baton Rouge, Louisiana, 미국, 70809
- 모병
- GI Alliance - Baton Rouge-Site Number: 8400129
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Mandeville, Louisiana, 미국, 70471
- 모병
- Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128
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Metairie, Louisiana, 미국, 70006
- 모병
- GI Alliance - Metairie-Site Number: 8400124
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Monroe, Louisiana, 미국, 71291
- 모병
- Delta Research Partners-Site Number: 8400087
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Missouri
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Liberty, Missouri, 미국, 64068
- 모병
- BVL Clinical Research-Site Number: 8400005
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St Louis, Missouri, 미국, 63141
- 모병
- Gateway Gastroenterology-Site Number: 8400097
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New York
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Maspeth, New York, 미국, 11378
- 모병
- MedTraits NY-Site Number: 8400045
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New York, New York, 미국, 10075
- 모병
- New York Gastroenterology Associates-Site Number: 8400009
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New York, New York, 미국, 10016
- 모병
- NYU Langone Health-Site Number: 8400091
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New York, New York, 미국, 10065
- 모병
- Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040
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North Carolina
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Chapel Hill, North Carolina, 미국, 27514
- 모병
- UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074
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Fayetteville, North Carolina, 미국, 28304
- 모병
- Cross Creek Medical Clinic-Site Number: 8400057
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Ohio
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Columbus, Ohio, 미국, 43202
- 모병
- Ohio Gastroenterology Group Inc.-Site Number: 8400006
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Columbus, Ohio, 미국, 43210
- 모병
- OSU Wexner Medical Center-Site Number: 8400077
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Columbus, Ohio, 미국, 43210
- 모병
- Medical Associates Research Group-Site Number: 8400063
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Westlake, Ohio, 미국, 44145
- 모병
- North Shore Gastroenterology Research-Site Number: 8400130
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104-6243
- 모병
- University of Pennsylvania School of Medicine-Site Number: 8400072
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Pittsburgh, Pennsylvania, 미국, 15212
- 모병
- The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107
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Rhode Island
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Providence, Rhode Island, 미국, 02904
- 모병
- University Gastroenterology - GI Alliance-Site Number: 8400103
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Texas
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Lubbock, Texas, 미국, 79410
- 모병
- GI Alliance - Lubbock-Site Number: 8400092
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Mesquite, Texas, 미국, 75149
- 모병
- SMS Clinical Research-Site Number: 8400035
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San Antonio, Texas, 미국, 78229
- 모병
- Gastroenterology Research of San Antonio LLC-Site Number: 8400054
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Southlake, Texas, 미국, 76092
- 모병
- Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake-Site Number: 8400101
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Tyler, Texas, 미국, 75701
- 모병
- Tyler Research Institute LLC-Site Number: 8400095
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Washington
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Vancouver, Washington, 미국, 98664
- 모병
- The Vancouver Clinic Inc. P.S.-Site Number: 8400090
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Wyoming
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Wyoming, Wyoming, 미국, 49519
- 모병
- Gastroenterology Associates of Western Michigan-Site Number: 8400060
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Yvoir, 벨기에, 5530
- 모병
- Investigational Site Number : 0560003
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Rousse, 불가리아, 7000
- 모병
- Investigational Site Number : 1000007
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Sofia, 불가리아, 1618
- 모병
- Investigational Site Number : 1000001
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Oblast Veliko Tirnovo
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Gorna Oryahovitsa, Oblast Veliko Tirnovo, 불가리아, 5100
- 모병
- Investigational Site Number : 1000003
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São José do Rio Preto, 브라질, 15090-000
- 모병
- Sao Jose do Rio Preto Regional Faculty of Medicine Foundation-Site Number: 0760006
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Belgrade, 세르비아, 11 080
- 모병
- Investigational Site Number : 6880002
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Basel, 스위스, CH-4058
- 모병
- Investigational Site Number : 7560002
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Bern, 스위스, 3012
- 모병
- Investigational Site Number : 7560001
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Bratislava, 슬로바키아, 811 09
- 모병
- Investigational Site Number : 7030001
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Vienna, 오스트리아, 1090
- 모병
- Investigational Site Number : 0400001
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Kyiv, 우크라이나, 2002
- 모병
- Investigational Site Number : 8040001
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Kyiv, 우크라이나, 2091
- 모병
- Investigational Site Number : 8040013
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Lviv, 우크라이나, 79000
- 모병
- Investigational Site Number : 8040004
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Lviv, 우크라이나, 79019
- 모병
- Investigational Site Number : 8040005
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Uzhhorod, 우크라이나, 88018
- 모병
- Investigational Site Number : 8040006
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Vinnytsia, 우크라이나, 21013
- 모병
- Investigational Site Number : 8040010
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Vinnytsia, 우크라이나, 21028
- 모병
- Investigational Site Number : 8040009
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Jerusalem, 이스라엘, 9103102
- 모병
- Investigational Site Number : 3760001
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Tel Aviv, 이스라엘, 6423906
- 모병
- Investigational Site Number : 3760002
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Rozzano, 이탈리아, 20089
- 모병
- Investigational Site Number : 3800003
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Turin, 이탈리아, 10128
- 모병
- Investigational Site Number : 3800005
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Kamakura, 일본, 247-0056
- 모병
- Investigational Site Number : 3920030
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Nishinomiya, 일본, 663-8501
- 모병
- Investigational Site Number : 3920013
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Tsu, 일본, 514-8507
- 모병
- Investigational Site Number : 3920009
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Guangzhou, 중국, 510655
- 모병
- Investigational Site Number : 1560002
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Huizhou, 중국, 516001
- 모병
- Investigational Site Number : 1560026
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Shanghai, 중국, 200123
- 모병
- Investigational Site Number : 1560020
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Wuxi, 중국, 214023
- 모병
- Investigational Site Number : 1560018
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Hradec Králové, 체코, 500 12
- 모병
- Investigational Site Number: 2030011
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Prague, 체코, 150 00
- 모병
- Investigational Site Number : 2030013
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Viña del Mar, 칠레, 2540488
- 모병
- Investigational Site Number : 1520001
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Edmonton, 캐나다, T6G 2X8
- 모병
- Investigational Site Number : 1240004
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Hamilton, 캐나다, L8N 1Y2
- 모병
- Investigational Site Number : 1240009
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London, 캐나다, N6K 1M6
- 모병
- Investigational Site Number : 1240013
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New Westminster, 캐나다, BC V3L 3W4
- 모병
- Investigational Site Number : 1240006
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Toronto, 캐나다, M6A 3B4
- 모병
- Investigational Site Number : 1240003
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Bydgoszcz, 폴란드, 85-229
- 모병
- Investigational Site Number : 6160026
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Elblag, 폴란드, 82-300
- 모병
- Investigational Site Number : 6160013
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Katowice, 폴란드, 40-748
- 모병
- Investigational Site Number : 6160014
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Kłodzko, 폴란드, 57-300
- 모병
- Investigational Site Number : 6160030
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Lublin, 폴란드, 20-049
- 모병
- Investigational Site Number : 6160034
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Rzeszów, 폴란드, 35-326
- 모병
- Investigational Site Number : 6160025
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Staszów, 폴란드, 28-200
- 모병
- Investigational Site Number : 6160007
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Szczecin, 폴란드, 71-685
- 모병
- Investigational Site Number : 6160020
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Torun, 폴란드, 87-100
- 모병
- Investigational Site Number : 6160023
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Wadowice, 폴란드, 34-100
- 모병
- Investigational Site Number : 6160012
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Warsaw, 폴란드, 04-501
- 모병
- Investigational Site Number : 6160008
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Wroclaw, 폴란드, 52-416
- 모병
- Investigational Site Number : 6160006
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Wroclaw, 폴란드, 54-239
- 모병
- Investigational Site Number : 6160017
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Salzburg, 호주, 5020
- 모병
- Investigational Site Number : 0400002
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Vienna, 호주, 1190
- 모병
- Investigational Site Number : 0400007
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Queensland
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South Brisbane, Queensland, 호주, 4101
- 모병
- Investigational Site Number : 0360001
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to <18 years of age who meet the definition of Tanner stage 5 for development)
- Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of STARSCAPE-1
- OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study
Exclusion Criteria:
- Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator
- Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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위약 비교기: Placebo
SC injection as per protocol |
Pharmaceutical form:Injection solution-Route of administration:SC injection |
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실험적: Duvakitug dose 1
Subcutaneous (SC) injection as per protocol |
Pharmaceutical form:Injection solution-Route of administration:SC injection
다른 이름들:
|
|
실험적: Du vakitug dose 2
SC injection as per protocol |
Pharmaceutical form:Injection solution-Route of administration:SC injection
다른 이름들:
|
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실험적: Du vakitug dose 3
SC injection as per protocol |
Pharmaceutical form:Injection solution-Route of administration:SC injection
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission (CDAI) at Week 40
기간: Week 40
|
Clinical Remission by Crohn's Disease Activity Index (CDAI): CDAI score <150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease. |
Week 40
|
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Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40
기간: Week 40
|
The SES-CD is a standardized method for evaluating disease activity. Score ranges from 0 to 56, where higher scores represent more severe disease. Endoscopic Response by SES-CD is a decrease in SES-CD ≥50% from Baseline (or a decrease of at least 2 points for participants with a Baseline score of 4 or more, and isolated ileal disease) based on central reading. |
Week 40
|
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Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission per PRO-2 at Week 40
기간: Week 40
|
Clinical Remission 2-item patient-reported outcome (PRO-2): average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline. |
Week 40
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
중추적 인 유지 보수 하위 연구 코호트 1 : 궤양이없는 내시경 검사를 달성하는 참가자의 비율 (기준선에서 궤양을 가진 참가자의 하위 집합).
기간: 40 주차
|
40 주차
|
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|
중추적 인 유지 보수 하위 연구 코호트 1 : CD 관련 입원의 발생률 40
기간: 0 주 ~ 주 40 주
|
0 주 ~ 주 40 주
|
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중추적 인 유지 보수 하위 연구 코호트 1 : 시간이 지남에 따라 측정 된 duvakitug의 혈청 농도
기간: 0 주 ~ 주 40 주
|
0 주 ~ 주 40 주
|
|
|
중추적 인 유지 보수 서브 연구 코호트 1 : Duvakitug에 대한 치료에 응급 항 약물 항체 (ADA)의 발생률
기간: 0 주 ~ 주 40 주
|
0 주 ~ 주 40 주
|
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|
중추적 인 유지 보수 서브 스터디 코호트 1 : 치료에 대한 부작용 (TEAES), 특별 관심사 (TEAESS), TE 심각한 부작용 (TESAES) 및 TEAES의 발생률은 영구 연구 중단으로 이어지는 TEAES
기간: 마지막 복용량 후 0-45 일
|
마지막 복용량 후 0-45 일
|
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|
Open-Label Extension 하위 연구 : TEAES, TEASIS, TESAES 및 TEAESLEADING의 발생률은 영구 연구 중단 중단
기간: 마지막 복용 후 45 일까지 중추적 유지 보수 40 주차
|
마지막 복용 후 45 일까지 중추적 유지 보수 40 주차
|
|
|
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical response Week 40
기간: Week 40
|
The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease. Clinical Response by CDAI: decrease in CDAI score of 100 points or more from Baseline. |
Week 40
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Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving SES-CD endoscopic remission at Week 40
기간: Week 40
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The SES-CD is a standardized method for evaluating disease activity. Score ranges from 0 to 56, where higher scores represent more severe disease. Endoscopic remission: a SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD sub score >1 point from Baseline. |
Week 40
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US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission and endoscopic remission at Week 40
기간: Week 40
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The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease. The SES-CD is a standardized method for evaluating disease activity. Score ranges from 0 to 56, where higher scores represent more severe disease. Clinical Remission by CDAI: CDAI score <150. Endoscopic remission: a SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD sub score >1 point from Baseline. |
Week 40
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EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission and endoscopic remission at Week 40
기간: Week 40
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Clinical Remission PRO-2: average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline. The SES-CD is a standardized method for evaluating disease activity. Score ranges from 0 to 56, where higher scores represent more severe disease. Endoscopic remission: a SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD sub score >1 point from Baseline. |
Week 40
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US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission at Week 40
기간: Week 40
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Clinical Remission PRO-2: average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline. |
Week 40
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EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission at Week 40
기간: Week 40
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Clinical Remission by CDAI: CDAI score <150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease. |
Week 40
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US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free CDAI clinical remission at Week 40
기간: Week 40
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Clinical Remission by CDAI: CDAI score <150 and without corticosteroid use for CD for at least 12 weeks prior to assessment. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease. |
Week 40
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EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free PRO-2 remission at Week 40
기간: Week 40
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Clinical Remission PRO-2: average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline and without corticosteroid use for CD for at least 12 weeks prior to assessment. |
Week 40
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US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission per CDAI at Week 40 in the subset of participants with clinical remission per CDAI at Week 0 (maintenance of clinical remission per CDAI)
기간: Week 40
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Clinical Remission by CDAI: CDAI score <150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease. |
Week 40
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EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission per PRO-2 at Week 40 in the subset of participants with clinical remission per PRO-2 at Week 0 (maintenance of clinical remission per PRO-2)
기간: Week 40
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Clinical Remission PRO-2: average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline. |
Week 40
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Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in PROMIS-Fatigue Short Form 7a T-score at Week 40
기간: Baseline, Week 40
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The PROMIS Fatigue Short Form 7a uses a 5-point Likert scale for each of its 7 items, resulting in a raw score range of 7 to 35. This raw score is then converted into a T-score, with a mean of 50 and a standard deviation of 10, based on US national norms. Higher T-scores indicate greater fatigue. |
Baseline, Week 40
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Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in IBDQ total score at Week 40
기간: Baseline, Week 40
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Inflammatory Bowel Disease Questionnaire (IBDQ) instrument consist of 32 items exploring 4 dimensions: "bowel symptoms" (10 items), "systemic symptoms" (5 items), "emotional function" (12 items) and "social function" (5 items). The total IBDQ total score ranges from 32 to 224 with higher score indicating better quality of life. |
Baseline, Week 40
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Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no bowel urgency by NRS at Week 40
기간: Week 40
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Numeric Rating Scale (NRS) for bowel urgency measures the severity of bowel urgency-the sudden or immediate need to have a bowel movement-experienced in the past 24 hours. This tool utilizes an 11-point scale for evaluation, where 0 represents "no urgency" and 10 signifies the "worst possible urgency". |
Week 40
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기본 완료 (추정된)
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연구 완료
연구 등록 날짜
최초 제출
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QC 기준을 충족하는 최초 제출
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처음 게시됨 (실제)
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연구 기록 업데이트
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QC 기준을 충족하는 마지막 업데이트 제출
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이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- EFC18327
- 2025-521037-86 (레지스트리 식별자: CTIS)
- U1111-1314-5471 (레지스트리 식별자: ICTRP)
- 2025 (미국 NIH 보조금/계약)
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 clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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