En vedligeholdelsesundersøgelse til at undersøge effektiviteten og sikkerheden af Duvakitug hos deltagere med moderat til alvorligt aktiv Crohns sygdom (STARSCAPE-2)
Et multicenter, multinationalt, randomiseret, dobbeltblindt, placebokontrolleret fase 3, vedligeholdelsesundersøgelse for at evaluere effektiviteten og sikkerheden af Duvakitug hos deltagere med moderat til alvorligt aktiv Crohns sygdom
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
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Trial Transparency email recommended (Toll free for US & Canada)
- Telefonnummer: option 6 800-633-1610
- E-mail: Contact-US@sanofi.com
Studiesteder
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Salzburg, Australien, 5020
- Rekruttering
- Investigational Site Number : 0400002
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Vienna, Australien, 1190
- Rekruttering
- Investigational Site Number : 0400007
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Queensland
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South Brisbane, Queensland, Australien, 4101
- Rekruttering
- Investigational Site Number : 0360001
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Yvoir, Belgien, 5530
- Rekruttering
- Investigational Site Number : 0560003
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São José do Rio Preto, Brasilien, 15090-000
- Rekruttering
- Sao Jose do Rio Preto Regional Faculty of Medicine Foundation-Site Number: 0760006
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Rousse, Bulgarien, 7000
- Rekruttering
- Investigational Site Number : 1000007
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Sofia, Bulgarien, 1618
- Rekruttering
- Investigational Site Number : 1000001
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Oblast Veliko Tirnovo
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Gorna Oryahovitsa, Oblast Veliko Tirnovo, Bulgarien, 5100
- Rekruttering
- Investigational Site Number : 1000003
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Edmonton, Canada, T6G 2X8
- Rekruttering
- Investigational Site Number : 1240004
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Hamilton, Canada, L8N 1Y2
- Rekruttering
- Investigational Site Number : 1240009
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London, Canada, N6K 1M6
- Rekruttering
- Investigational Site Number : 1240013
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New Westminster, Canada, BC V3L 3W4
- Rekruttering
- Investigational Site Number : 1240006
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Toronto, Canada, M6A 3B4
- Rekruttering
- Investigational Site Number : 1240003
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Viña del Mar, Chile, 2540488
- Rekruttering
- Investigational Site Number : 1520001
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80907
- Rekruttering
- Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
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Florida
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Kissimmee, Florida, Forenede Stater, 34741
- Rekruttering
- Clinical Research of Osceola-Site Number: 8400013
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Miami, Florida, Forenede Stater, 33125
- Rekruttering
- Columbus Clinical Services LLc-Site Number: 8400038
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Miami, Florida, Forenede Stater, 33175
- Rekruttering
- Bioresearch Partner-Kendale Lakes-Site Number: 8400053
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Orlando, Florida, Forenede Stater, 32806
- Rekruttering
- Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084
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Tampa, Florida, Forenede Stater, 33607
- Rekruttering
- NMC Research LLC-Site Number: 8400033
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Illinois
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Gurnee, Illinois, Forenede Stater, 60031
- Rekruttering
- Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee-Site Number: 8400049
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Indiana
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New Albany, Indiana, Forenede Stater, 47150
- Rekruttering
- Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809
- Rekruttering
- GI Alliance - Baton Rouge-Site Number: 8400129
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Mandeville, Louisiana, Forenede Stater, 70471
- Rekruttering
- Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128
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Metairie, Louisiana, Forenede Stater, 70006
- Rekruttering
- GI Alliance - Metairie-Site Number: 8400124
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Monroe, Louisiana, Forenede Stater, 71291
- Rekruttering
- Delta Research Partners-Site Number: 8400087
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Missouri
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Liberty, Missouri, Forenede Stater, 64068
- Rekruttering
- BVL Clinical Research-Site Number: 8400005
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St Louis, Missouri, Forenede Stater, 63141
- Rekruttering
- Gateway Gastroenterology-Site Number: 8400097
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New York
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Maspeth, New York, Forenede Stater, 11378
- Rekruttering
- MedTraits NY-Site Number: 8400045
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New York, New York, Forenede Stater, 10075
- Rekruttering
- New York Gastroenterology Associates-Site Number: 8400009
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New York, New York, Forenede Stater, 10016
- Rekruttering
- NYU Langone Health-Site Number: 8400091
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New York, New York, Forenede Stater, 10065
- Rekruttering
- Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27514
- Rekruttering
- UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074
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Fayetteville, North Carolina, Forenede Stater, 28304
- Rekruttering
- Cross Creek Medical Clinic-Site Number: 8400057
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Ohio
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Columbus, Ohio, Forenede Stater, 43202
- Rekruttering
- Ohio Gastroenterology Group Inc.-Site Number: 8400006
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Columbus, Ohio, Forenede Stater, 43210
- Rekruttering
- OSU Wexner Medical Center-Site Number: 8400077
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Columbus, Ohio, Forenede Stater, 43210
- Rekruttering
- Medical Associates Research Group-Site Number: 8400063
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Westlake, Ohio, Forenede Stater, 44145
- Rekruttering
- North Shore Gastroenterology Research-Site Number: 8400130
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104-6243
- Rekruttering
- University of Pennsylvania School of Medicine-Site Number: 8400072
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Pittsburgh, Pennsylvania, Forenede Stater, 15212
- Rekruttering
- 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, Forenede Stater, 02904
- Rekruttering
- University Gastroenterology - GI Alliance-Site Number: 8400103
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Texas
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Lubbock, Texas, Forenede Stater, 79410
- Rekruttering
- GI Alliance - Lubbock-Site Number: 8400092
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Mesquite, Texas, Forenede Stater, 75149
- Rekruttering
- SMS Clinical Research-Site Number: 8400035
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San Antonio, Texas, Forenede Stater, 78229
- Rekruttering
- Gastroenterology Research of San Antonio LLC-Site Number: 8400054
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Southlake, Texas, Forenede Stater, 76092
- Rekruttering
- Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake-Site Number: 8400101
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Tyler, Texas, Forenede Stater, 75701
- Rekruttering
- Tyler Research Institute LLC-Site Number: 8400095
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Washington
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Vancouver, Washington, Forenede Stater, 98664
- Rekruttering
- The Vancouver Clinic Inc. P.S.-Site Number: 8400090
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Wyoming
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Wyoming, Wyoming, Forenede Stater, 49519
- Rekruttering
- Gastroenterology Associates of Western Michigan-Site Number: 8400060
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Tbilisi, Georgien, 159
- Rekruttering
- Investigational Site Number : 2680003
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Tbilisi, Georgien, 180
- Rekruttering
- Investigational Site Number : 2680002
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Tbilisi, Georgien, 180
- Rekruttering
- Investigational Site Number : 2680004
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Tbilisi, Georgien, 102
- Rekruttering
- Investigational Site Number : 2680006
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Tbilisi, Georgien, 144
- Rekruttering
- Investigational Site Number : 2680008
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Tbilisi, Georgien, 160
- Rekruttering
- Investigational Site Number : 2680005
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Tilburg, Holland, 5022 GC
- Rekruttering
- Investigational Site Number : 5280003
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Jerusalem, Israel, 9103102
- Rekruttering
- Investigational Site Number : 3760001
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Tel Aviv, Israel, 6423906
- Rekruttering
- Investigational Site Number : 3760002
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Rozzano, Italien, 20089
- Rekruttering
- Investigational Site Number : 3800003
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Turin, Italien, 10128
- Rekruttering
- Investigational Site Number : 3800005
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Kamakura, Japan, 247-0056
- Rekruttering
- Investigational Site Number : 3920030
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Nishinomiya, Japan, 663-8501
- Rekruttering
- Investigational Site Number : 3920013
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Tsu, Japan, 514-8507
- Rekruttering
- Investigational Site Number : 3920009
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Guangzhou, Kina, 510655
- Rekruttering
- Investigational Site Number : 1560002
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Huizhou, Kina, 516001
- Rekruttering
- Investigational Site Number : 1560026
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Shanghai, Kina, 200123
- Rekruttering
- Investigational Site Number : 1560020
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Wuxi, Kina, 214023
- Rekruttering
- Investigational Site Number : 1560018
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Kaunas, Litauen, LT-50161
- Rekruttering
- Investigational Site Number : 4400001
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Chisinau, Moldova, MD-2025
- Rekruttering
- Investigational Site Number : 4980003
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Chisinau, Moldova, MD-2025
- Rekruttering
- Investigational Site Number : 4980002
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Chisinau, Moldova, MD-2068
- Rekruttering
- Investigational Site Number : 4980004
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Lower Hutt, New Zealand, 5010
- Rekruttering
- Investigational Site Number : 5540003
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Bydgoszcz, Polen, 85-229
- Rekruttering
- Investigational Site Number : 6160026
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Elblag, Polen, 82-300
- Rekruttering
- Investigational Site Number : 6160013
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Katowice, Polen, 40-748
- Rekruttering
- Investigational Site Number : 6160014
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Kłodzko, Polen, 57-300
- Rekruttering
- Investigational Site Number : 6160030
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Lublin, Polen, 20-049
- Rekruttering
- Investigational Site Number : 6160034
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Rzeszów, Polen, 35-326
- Rekruttering
- Investigational Site Number : 6160025
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Staszów, Polen, 28-200
- Rekruttering
- Investigational Site Number : 6160007
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Szczecin, Polen, 71-685
- Rekruttering
- Investigational Site Number : 6160020
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Torun, Polen, 87-100
- Rekruttering
- Investigational Site Number : 6160023
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Wadowice, Polen, 34-100
- Rekruttering
- Investigational Site Number : 6160012
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Warsaw, Polen, 04-501
- Rekruttering
- Investigational Site Number : 6160008
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Wroclaw, Polen, 52-416
- Rekruttering
- Investigational Site Number : 6160006
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Wroclaw, Polen, 54-239
- Rekruttering
- Investigational Site Number : 6160017
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Basel, Schweiz, CH-4058
- Rekruttering
- Investigational Site Number : 7560002
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Bern, Schweiz, 3012
- Rekruttering
- Investigational Site Number : 7560001
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Belgrade, Serbien, 11 080
- Rekruttering
- Investigational Site Number : 6880002
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Bratislava, Slovakiet, 811 09
- Rekruttering
- Investigational Site Number : 7030001
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Cape Town, Sydafrika, 7405
- Rekruttering
- Investigational Site Number : 7100002
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Durban, Sydafrika, 3610
- Rekruttering
- Investigational Site Number : 7100004
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Kempton Park, Sydafrika, 1619
- Rekruttering
- Investigational Site Number : 7100001
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Busan, Sydkorea, 48108
- Rekruttering
- Investigational Site Number : 4100008
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Gwangju, Sydkorea, 61453
- Rekruttering
- Investigational Site Number : 4100007
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Seoul, Sydkorea, 6351
- Rekruttering
- Investigational Site Number : 4100006
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Seoul, Sydkorea, 6973
- Rekruttering
- Investigational Site Number : 4100002
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Changhua County, Taiwan, 500209
- Rekruttering
- Investigational Site Number : 1580005
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Hradec Králové, Tjekkiet, 500 12
- Rekruttering
- Investigational Site Number: 2030011
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Prague, Tjekkiet, 150 00
- Rekruttering
- Investigational Site Number : 2030013
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Baden-Wurttemberg
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Ulm, Baden-Wurttemberg, Tyskland, 89081
- Rekruttering
- Investigational Site Number : 2760005
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Saxony
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Leipzig, Saxony, Tyskland, 4103
- Rekruttering
- Investigational Site Number : 2760015
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, Tyskland, 24105
- Rekruttering
- Investigational Site Number : 2760001
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Kyiv, Ukraine, 2002
- Rekruttering
- Investigational Site Number : 8040001
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Kyiv, Ukraine, 2091
- Rekruttering
- Investigational Site Number : 8040013
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Lviv, Ukraine, 79000
- Rekruttering
- Investigational Site Number : 8040004
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Lviv, Ukraine, 79019
- Rekruttering
- Investigational Site Number : 8040005
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Uzhhorod, Ukraine, 88018
- Rekruttering
- Investigational Site Number : 8040006
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Vinnytsia, Ukraine, 21013
- Rekruttering
- Investigational Site Number : 8040010
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Vinnytsia, Ukraine, 21028
- Rekruttering
- Investigational Site Number : 8040009
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Vienna, Østrig, 1090
- Rekruttering
- Investigational Site Number : 0400001
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
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Placebo komparator: Placebo
SC injection as per protocol |
Pharmaceutical form:Injection solution-Route of administration:SC injection |
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Eksperimentel: Duvakitug dose 1
Subcutaneous (SC) injection as per protocol |
Pharmaceutical form:Injection solution-Route of administration:SC injection
Andre navne:
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Eksperimentel: Du vakitug dose 2
SC injection as per protocol |
Pharmaceutical form:Injection solution-Route of administration:SC injection
Andre navne:
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Eksperimentel: Du vakitug dose 3
SC injection as per protocol |
Pharmaceutical form:Injection solution-Route of administration:SC injection
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pivotal vedligeholdelsesunderstudie-kohort 1: Andel af deltagere, der opnår mavesårfri endoskopi (i undergruppen af deltagere med mavesår ved baseline) i uge 40
Tidsramme: Uge 40
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Uge 40
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Pivotal vedligeholdelsesunderstudie-kohort 1: Forekomst af CD-relateret hospitalisering inden uge 40
Tidsramme: Uge 0 til uge 40
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Uge 0 til uge 40
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Pivotal vedligeholdelsesunderstudie-kohort 1: Serumkoncentrationer af Duvakitug målt over tid
Tidsramme: Uge 0 til uge 40
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Uge 0 til uge 40
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Pivotal vedligeholdelsesunderstudie-kohort 1: Forekomst af behandlingsvingerantidrug antistof (ADA) mod Duvakitug
Tidsramme: Uge 0 til uge 40
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Uge 0 til uge 40
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Pivotal vedligeholdelsesunderstudium-kohort 1: Forekomst af behandling af behandlingsvækstbegivenheder (TEAE'er), tee af særlig interesse (teese), TE alvorlige bivirkninger (TESAES) og TEAE'er, der fører til permanent undersøgelse
Tidsramme: Uge 0 til 45 dage efter sidste dosis
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Uge 0 til 45 dage efter sidste dosis
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Open-Label Extension Sub-Study: Forekomst af tees, teese, tesaes og teesleading til permanent ophør med studieintervention
Tidsramme: Uge 40 af pivotal vedligeholdelse gennem 45 dage efter sidste dosis
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Uge 40 af pivotal vedligeholdelse gennem 45 dage efter sidste dosis
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Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical response Week 40
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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. 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- EFC18327
- 2025-521037-86 (Registry Identifier: CTIS)
- U1111-1314-5471 (Registry Identifier: ICTRP)
- 2025 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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