Uno studio di manutenzione per studiare l'efficacia e la sicurezza di Duvakitug nei partecipanti con malattia da moderatamente a gravemente attiva (STARSCAPE-2)
Una fase 3 multicentrica, multinazionale, randomizzata, in doppio cieco, controllata con placebo 3, studio di manutenzione per valutare l'efficacia e la sicurezza di Duvakitug nei partecipanti con malattia da moderatamente a gravemente attiva
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
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Fase 3
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Trial Transparency email recommended (Toll free for US & Canada)
- Numero di telefono: option 6 800-633-1610
- Email: Contact-US@sanofi.com
Luoghi di studio
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Salzburg, Australia, 5020
- Reclutamento
- Investigational Site Number : 0400002
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Vienna, Australia, 1190
- Reclutamento
- Investigational Site Number : 0400007
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Queensland
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South Brisbane, Queensland, Australia, 4101
- Reclutamento
- Investigational Site Number : 0360001
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Vienna, Austria, 1090
- Reclutamento
- Investigational Site Number : 0400001
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Yvoir, Belgio, 5530
- Reclutamento
- Investigational Site Number : 0560003
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São José do Rio Preto, Brasile, 15090-000
- Reclutamento
- Sao Jose do Rio Preto Regional Faculty of Medicine Foundation-Site Number: 0760006
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Rousse, Bulgaria, 7000
- Reclutamento
- Investigational Site Number : 1000007
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Sofia, Bulgaria, 1618
- Reclutamento
- Investigational Site Number : 1000001
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Oblast Veliko Tirnovo
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Gorna Oryahovitsa, Oblast Veliko Tirnovo, Bulgaria, 5100
- Reclutamento
- Investigational Site Number : 1000003
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Edmonton, Canada, T6G 2X8
- Reclutamento
- Investigational Site Number : 1240004
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Hamilton, Canada, L8N 1Y2
- Reclutamento
- Investigational Site Number : 1240009
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London, Canada, N6K 1M6
- Reclutamento
- Investigational Site Number : 1240013
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New Westminster, Canada, BC V3L 3W4
- Reclutamento
- Investigational Site Number : 1240006
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Toronto, Canada, M6A 3B4
- Reclutamento
- Investigational Site Number : 1240003
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Hradec Králové, Cechia, 500 12
- Reclutamento
- Investigational Site Number: 2030011
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Prague, Cechia, 150 00
- Reclutamento
- Investigational Site Number : 2030013
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Viña del Mar, Chile, 2540488
- Reclutamento
- Investigational Site Number : 1520001
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Guangzhou, Cina, 510655
- Reclutamento
- Investigational Site Number : 1560002
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Huizhou, Cina, 516001
- Reclutamento
- Investigational Site Number : 1560026
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Shanghai, Cina, 200123
- Reclutamento
- Investigational Site Number : 1560020
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Wuxi, Cina, 214023
- Reclutamento
- Investigational Site Number : 1560018
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Busan, Corea del Sud, 48108
- Reclutamento
- Investigational Site Number : 4100008
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Gwangju, Corea del Sud, 61453
- Reclutamento
- Investigational Site Number : 4100007
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Seoul, Corea del Sud, 6351
- Reclutamento
- Investigational Site Number : 4100006
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Seoul, Corea del Sud, 6973
- Reclutamento
- Investigational Site Number : 4100002
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Tbilisi, Georgia, 159
- Reclutamento
- Investigational Site Number : 2680003
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Tbilisi, Georgia, 180
- Reclutamento
- Investigational Site Number : 2680002
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Tbilisi, Georgia, 180
- Reclutamento
- Investigational Site Number : 2680004
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Tbilisi, Georgia, 102
- Reclutamento
- Investigational Site Number : 2680006
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Tbilisi, Georgia, 144
- Reclutamento
- Investigational Site Number : 2680008
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Tbilisi, Georgia, 160
- Reclutamento
- Investigational Site Number : 2680005
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Baden-Wurttemberg
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Ulm, Baden-Wurttemberg, Germania, 89081
- Reclutamento
- Investigational Site Number : 2760005
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Saxony
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Leipzig, Saxony, Germania, 4103
- Reclutamento
- Investigational Site Number : 2760015
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, Germania, 24105
- Reclutamento
- Investigational Site Number : 2760001
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Kamakura, Giappone, 247-0056
- Reclutamento
- Investigational Site Number : 3920030
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Nishinomiya, Giappone, 663-8501
- Reclutamento
- Investigational Site Number : 3920013
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Tsu, Giappone, 514-8507
- Reclutamento
- Investigational Site Number : 3920009
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Jerusalem, Israele, 9103102
- Reclutamento
- Investigational Site Number : 3760001
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Tel Aviv, Israele, 6423906
- Reclutamento
- Investigational Site Number : 3760002
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Rozzano, Italia, 20089
- Reclutamento
- Investigational Site Number : 3800003
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Turin, Italia, 10128
- Reclutamento
- Investigational Site Number : 3800005
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Kaunas, Lituania, LT-50161
- Reclutamento
- Investigational Site Number : 4400001
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Chisinau, Moldavia, MD-2025
- Reclutamento
- Investigational Site Number : 4980003
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Chisinau, Moldavia, MD-2025
- Reclutamento
- Investigational Site Number : 4980002
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Chisinau, Moldavia, MD-2068
- Reclutamento
- Investigational Site Number : 4980004
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Lower Hutt, Nuova Zelanda, 5010
- Reclutamento
- Investigational Site Number : 5540003
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Tilburg, Olanda, 5022 GC
- Reclutamento
- Investigational Site Number : 5280003
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Bydgoszcz, Polonia, 85-229
- Reclutamento
- Investigational Site Number : 6160026
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Elblag, Polonia, 82-300
- Reclutamento
- Investigational Site Number : 6160013
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Katowice, Polonia, 40-748
- Reclutamento
- Investigational Site Number : 6160014
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Kłodzko, Polonia, 57-300
- Reclutamento
- Investigational Site Number : 6160030
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Lublin, Polonia, 20-049
- Reclutamento
- Investigational Site Number : 6160034
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Rzeszów, Polonia, 35-326
- Reclutamento
- Investigational Site Number : 6160025
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Staszów, Polonia, 28-200
- Reclutamento
- Investigational Site Number : 6160007
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Szczecin, Polonia, 71-685
- Reclutamento
- Investigational Site Number : 6160020
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Torun, Polonia, 87-100
- Reclutamento
- Investigational Site Number : 6160023
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Wadowice, Polonia, 34-100
- Reclutamento
- Investigational Site Number : 6160012
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Warsaw, Polonia, 04-501
- Reclutamento
- Investigational Site Number : 6160008
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Wroclaw, Polonia, 52-416
- Reclutamento
- Investigational Site Number : 6160006
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Wroclaw, Polonia, 54-239
- Reclutamento
- Investigational Site Number : 6160017
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Belgrade, Serbia, 11 080
- Reclutamento
- Investigational Site Number : 6880002
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Bratislava, Slovacchia, 811 09
- Reclutamento
- Investigational Site Number : 7030001
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Colorado
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Colorado Springs, Colorado, Stati Uniti, 80907
- Reclutamento
- Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
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Florida
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Kissimmee, Florida, Stati Uniti, 34741
- Reclutamento
- Clinical Research of Osceola-Site Number: 8400013
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Miami, Florida, Stati Uniti, 33125
- Reclutamento
- Columbus Clinical Services LLc-Site Number: 8400038
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Miami, Florida, Stati Uniti, 33175
- Reclutamento
- Bioresearch Partner-Kendale Lakes-Site Number: 8400053
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Orlando, Florida, Stati Uniti, 32806
- Reclutamento
- Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084
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Tampa, Florida, Stati Uniti, 33607
- Reclutamento
- NMC Research LLC-Site Number: 8400033
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Illinois
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Gurnee, Illinois, Stati Uniti, 60031
- Reclutamento
- Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee-Site Number: 8400049
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Indiana
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New Albany, Indiana, Stati Uniti, 47150
- Reclutamento
- Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100
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Louisiana
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Baton Rouge, Louisiana, Stati Uniti, 70809
- Reclutamento
- GI Alliance - Baton Rouge-Site Number: 8400129
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Mandeville, Louisiana, Stati Uniti, 70471
- Reclutamento
- Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128
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Metairie, Louisiana, Stati Uniti, 70006
- Reclutamento
- GI Alliance - Metairie-Site Number: 8400124
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Monroe, Louisiana, Stati Uniti, 71291
- Reclutamento
- Delta Research Partners-Site Number: 8400087
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Missouri
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Liberty, Missouri, Stati Uniti, 64068
- Reclutamento
- BVL Clinical Research-Site Number: 8400005
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St Louis, Missouri, Stati Uniti, 63141
- Reclutamento
- Gateway Gastroenterology-Site Number: 8400097
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New York
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Maspeth, New York, Stati Uniti, 11378
- Reclutamento
- MedTraits NY-Site Number: 8400045
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New York, New York, Stati Uniti, 10075
- Reclutamento
- New York Gastroenterology Associates-Site Number: 8400009
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New York, New York, Stati Uniti, 10016
- Reclutamento
- NYU Langone Health-Site Number: 8400091
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New York, New York, Stati Uniti, 10065
- Reclutamento
- Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27514
- Reclutamento
- UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074
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Fayetteville, North Carolina, Stati Uniti, 28304
- Reclutamento
- Cross Creek Medical Clinic-Site Number: 8400057
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Ohio
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Columbus, Ohio, Stati Uniti, 43202
- Reclutamento
- Ohio Gastroenterology Group Inc.-Site Number: 8400006
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Columbus, Ohio, Stati Uniti, 43210
- Reclutamento
- OSU Wexner Medical Center-Site Number: 8400077
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Columbus, Ohio, Stati Uniti, 43210
- Reclutamento
- Medical Associates Research Group-Site Number: 8400063
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Westlake, Ohio, Stati Uniti, 44145
- Reclutamento
- North Shore Gastroenterology Research-Site Number: 8400130
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104-6243
- Reclutamento
- University of Pennsylvania School of Medicine-Site Number: 8400072
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Pittsburgh, Pennsylvania, Stati Uniti, 15212
- Reclutamento
- 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, Stati Uniti, 02904
- Reclutamento
- University Gastroenterology - GI Alliance-Site Number: 8400103
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Texas
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Lubbock, Texas, Stati Uniti, 79410
- Reclutamento
- GI Alliance - Lubbock-Site Number: 8400092
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Mesquite, Texas, Stati Uniti, 75149
- Reclutamento
- SMS Clinical Research-Site Number: 8400035
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San Antonio, Texas, Stati Uniti, 78229
- Reclutamento
- Gastroenterology Research of San Antonio LLC-Site Number: 8400054
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Southlake, Texas, Stati Uniti, 76092
- Reclutamento
- Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake-Site Number: 8400101
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Tyler, Texas, Stati Uniti, 75701
- Reclutamento
- Tyler Research Institute LLC-Site Number: 8400095
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Washington
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Vancouver, Washington, Stati Uniti, 98664
- Reclutamento
- The Vancouver Clinic Inc. P.S.-Site Number: 8400090
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Wyoming
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Wyoming, Wyoming, Stati Uniti, 49519
- Reclutamento
- Gastroenterology Associates of Western Michigan-Site Number: 8400060
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Cape Town, Sud Africa, 7405
- Reclutamento
- Investigational Site Number : 7100002
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Durban, Sud Africa, 3610
- Reclutamento
- Investigational Site Number : 7100004
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Kempton Park, Sud Africa, 1619
- Reclutamento
- Investigational Site Number : 7100001
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Basel, Svizzera, CH-4058
- Reclutamento
- Investigational Site Number : 7560002
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Bern, Svizzera, 3012
- Reclutamento
- Investigational Site Number : 7560001
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Changhua County, Taiwan, 500209
- Reclutamento
- Investigational Site Number : 1580005
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Kyiv, Ucraina, 2002
- Reclutamento
- Investigational Site Number : 8040001
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Kyiv, Ucraina, 2091
- Reclutamento
- Investigational Site Number : 8040013
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Lviv, Ucraina, 79000
- Reclutamento
- Investigational Site Number : 8040004
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Lviv, Ucraina, 79019
- Reclutamento
- Investigational Site Number : 8040005
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Uzhhorod, Ucraina, 88018
- Reclutamento
- Investigational Site Number : 8040006
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Vinnytsia, Ucraina, 21013
- Reclutamento
- Investigational Site Number : 8040010
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Vinnytsia, Ucraina, 21028
- Reclutamento
- Investigational Site Number : 8040009
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Comparatore placebo: Placebo
SC injection as per protocol |
Pharmaceutical form:Injection solution-Route of administration:SC injection |
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Sperimentale: Duvakitug dose 1
Subcutaneous (SC) injection as per protocol |
Pharmaceutical form:Injection solution-Route of administration:SC injection
Altri nomi:
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Sperimentale: Du vakitug dose 2
SC injection as per protocol |
Pharmaceutical form:Injection solution-Route of administration:SC injection
Altri nomi:
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Sperimentale: Du vakitug dose 3
SC injection as per protocol |
Pharmaceutical form:Injection solution-Route of administration:SC injection
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission (CDAI) at Week 40
Lasso di tempo: Week 40
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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
Lasso di tempo: 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 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
Lasso di tempo: Week 40
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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
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Coorte sub-studio di manutenzione fondamentale 1: proporzione di partecipanti che raggiungono l'endoscopia senza ulceri (nel sottoinsieme di partecipanti con ulcere al basale) alla settimana 40
Lasso di tempo: Settimana 40
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Settimana 40
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Coorte sub-studio di manutenzione fondamentale 1: incidenza del ricovero relativo al CD entro la settimana 40
Lasso di tempo: Settimana da 0 alla settimana 40
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Settimana da 0 alla settimana 40
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Coorte sub-studio di manutenzione fondamentale 1: concentrazioni sieriche di duvakitug misurate nel tempo
Lasso di tempo: Settimana da 0 alla settimana 40
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Settimana da 0 alla settimana 40
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Coorte sub-studio di mantenimento fondamentale 1: incidenza di anticorpo antidrug emergente (ADA) contro Duvakitug
Lasso di tempo: Settimana da 0 alla settimana 40
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Settimana da 0 alla settimana 40
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Coorte sub-studio di manutenzione fondamentale 1: incidenza di eventi avversi emergenti (Teaes), teae di interesse speciale (teasi), eventi avversi gravi (tesae) e teaes che portano a una sospensione permanente di intervento di studio
Lasso di tempo: Settimana da 0 a 45 giorni dopo l'ultima dose
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Settimana da 0 a 45 giorni dopo l'ultima dose
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Sub-studio di estensione in aperto: incidenza di teai, teasi, tesae e teaesle che si estendono per l'intervento di studio permanente
Lasso di tempo: Settimana 40 della manutenzione fondamentale per 45 giorni dopo l'ultima dose
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Settimana 40 della manutenzione fondamentale per 45 giorni dopo l'ultima dose
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Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical response Week 40
Lasso di tempo: 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. 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Date di iscrizione allo studio
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Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
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Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- EFC18327
- 2025-521037-86 (Identificatore di registro: CTIS)
- U1111-1314-5471 (Identificatore di registro: ICTRP)
- 2025 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .