En underhållsstudie för att undersöka effektiviteten och säkerheten för Duvakitug hos deltagare med måttligt till allvarligt aktiv Crohns sjukdom (STARSCAPE-2)
En multicenter, multinationell, randomiserad, dubbelblind, placebokontrollerad fas 3, underhållsstudie för att utvärdera effektiviteten och säkerheten för Duvakitug hos deltagare med måttligt till allvarligt aktiv Crohns sjukdom
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Trial Transparency email recommended (Toll free for US & Canada)
- Telefonnummer: option 6 800-633-1610
- E-post: Contact-US@sanofi.com
Studieorter
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Salzburg, Australien, 5020
- Rekrytering
- Investigational Site Number : 0400002
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Vienna, Australien, 1190
- Rekrytering
- Investigational Site Number : 0400007
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Queensland
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South Brisbane, Queensland, Australien, 4101
- Rekrytering
- Investigational Site Number : 0360001
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Yvoir, Belgien, 5530
- Rekrytering
- Investigational Site Number : 0560003
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São José do Rio Preto, Brasilien, 15090-000
- Rekrytering
- Sao Jose do Rio Preto Regional Faculty of Medicine Foundation-Site Number: 0760006
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Rousse, Bulgarien, 7000
- Rekrytering
- Investigational Site Number : 1000007
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Sofia, Bulgarien, 1618
- Rekrytering
- Investigational Site Number : 1000001
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Oblast Veliko Tirnovo
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Gorna Oryahovitsa, Oblast Veliko Tirnovo, Bulgarien, 5100
- Rekrytering
- Investigational Site Number : 1000003
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Viña del Mar, Chile, 2540488
- Rekrytering
- Investigational Site Number : 1520001
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Colorado
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Colorado Springs, Colorado, Förenta staterna, 80907
- Rekrytering
- Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
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Florida
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Kissimmee, Florida, Förenta staterna, 34741
- Rekrytering
- Clinical Research of Osceola-Site Number: 8400013
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Miami, Florida, Förenta staterna, 33125
- Rekrytering
- Columbus Clinical Services LLc-Site Number: 8400038
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Miami, Florida, Förenta staterna, 33175
- Rekrytering
- Bioresearch Partner-Kendale Lakes-Site Number: 8400053
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Orlando, Florida, Förenta staterna, 32806
- Rekrytering
- Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084
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Tampa, Florida, Förenta staterna, 33607
- Rekrytering
- NMC Research LLC-Site Number: 8400033
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Illinois
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Gurnee, Illinois, Förenta staterna, 60031
- Rekrytering
- Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee-Site Number: 8400049
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Indiana
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New Albany, Indiana, Förenta staterna, 47150
- Rekrytering
- Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100
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Louisiana
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Baton Rouge, Louisiana, Förenta staterna, 70809
- Rekrytering
- GI Alliance - Baton Rouge-Site Number: 8400129
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Mandeville, Louisiana, Förenta staterna, 70471
- Rekrytering
- Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128
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Metairie, Louisiana, Förenta staterna, 70006
- Rekrytering
- GI Alliance - Metairie-Site Number: 8400124
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Monroe, Louisiana, Förenta staterna, 71291
- Rekrytering
- Delta Research Partners-Site Number: 8400087
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Missouri
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Liberty, Missouri, Förenta staterna, 64068
- Rekrytering
- BVL Clinical Research-Site Number: 8400005
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St Louis, Missouri, Förenta staterna, 63141
- Rekrytering
- Gateway Gastroenterology-Site Number: 8400097
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New York
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Maspeth, New York, Förenta staterna, 11378
- Rekrytering
- MedTraits NY-Site Number: 8400045
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New York, New York, Förenta staterna, 10075
- Rekrytering
- New York Gastroenterology Associates-Site Number: 8400009
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New York, New York, Förenta staterna, 10016
- Rekrytering
- NYU Langone Health-Site Number: 8400091
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New York, New York, Förenta staterna, 10065
- Rekrytering
- Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27514
- Rekrytering
- UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074
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Fayetteville, North Carolina, Förenta staterna, 28304
- Rekrytering
- Cross Creek Medical Clinic-Site Number: 8400057
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Ohio
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Columbus, Ohio, Förenta staterna, 43202
- Rekrytering
- Ohio Gastroenterology Group Inc.-Site Number: 8400006
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Columbus, Ohio, Förenta staterna, 43210
- Rekrytering
- OSU Wexner Medical Center-Site Number: 8400077
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Columbus, Ohio, Förenta staterna, 43210
- Rekrytering
- Medical Associates Research Group-Site Number: 8400063
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Westlake, Ohio, Förenta staterna, 44145
- Rekrytering
- North Shore Gastroenterology Research-Site Number: 8400130
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104-6243
- Rekrytering
- University of Pennsylvania School of Medicine-Site Number: 8400072
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Pittsburgh, Pennsylvania, Förenta staterna, 15212
- Rekrytering
- 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, Förenta staterna, 02904
- Rekrytering
- University Gastroenterology - GI Alliance-Site Number: 8400103
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Texas
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Lubbock, Texas, Förenta staterna, 79410
- Rekrytering
- GI Alliance - Lubbock-Site Number: 8400092
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Mesquite, Texas, Förenta staterna, 75149
- Rekrytering
- SMS Clinical Research-Site Number: 8400035
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San Antonio, Texas, Förenta staterna, 78229
- Rekrytering
- Gastroenterology Research of San Antonio LLC-Site Number: 8400054
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Southlake, Texas, Förenta staterna, 76092
- Rekrytering
- Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake-Site Number: 8400101
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Tyler, Texas, Förenta staterna, 75701
- Rekrytering
- Tyler Research Institute LLC-Site Number: 8400095
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Washington
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Vancouver, Washington, Förenta staterna, 98664
- Rekrytering
- The Vancouver Clinic Inc. P.S.-Site Number: 8400090
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Wyoming
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Wyoming, Wyoming, Förenta staterna, 49519
- Rekrytering
- Gastroenterology Associates of Western Michigan-Site Number: 8400060
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Tbilisi, Georgien, 159
- Rekrytering
- Investigational Site Number : 2680003
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Tbilisi, Georgien, 180
- Rekrytering
- Investigational Site Number : 2680002
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Tbilisi, Georgien, 180
- Rekrytering
- Investigational Site Number : 2680004
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Tbilisi, Georgien, 102
- Rekrytering
- Investigational Site Number : 2680006
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Tbilisi, Georgien, 144
- Rekrytering
- Investigational Site Number : 2680008
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Tbilisi, Georgien, 160
- Rekrytering
- Investigational Site Number : 2680005
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Jerusalem, Israel, 9103102
- Rekrytering
- Investigational Site Number : 3760001
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Tel Aviv, Israel, 6423906
- Rekrytering
- Investigational Site Number : 3760002
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Rozzano, Italien, 20089
- Rekrytering
- Investigational Site Number : 3800003
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Turin, Italien, 10128
- Rekrytering
- Investigational Site Number : 3800005
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Kamakura, Japan, 247-0056
- Rekrytering
- Investigational Site Number : 3920030
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Nishinomiya, Japan, 663-8501
- Rekrytering
- Investigational Site Number : 3920013
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Tsu, Japan, 514-8507
- Rekrytering
- Investigational Site Number : 3920009
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Edmonton, Kanada, T6G 2X8
- Rekrytering
- Investigational Site Number : 1240004
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Hamilton, Kanada, L8N 1Y2
- Rekrytering
- Investigational Site Number : 1240009
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London, Kanada, N6K 1M6
- Rekrytering
- Investigational Site Number : 1240013
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New Westminster, Kanada, BC V3L 3W4
- Rekrytering
- Investigational Site Number : 1240006
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Toronto, Kanada, M6A 3B4
- Rekrytering
- Investigational Site Number : 1240003
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Guangzhou, Kina, 510655
- Rekrytering
- Investigational Site Number : 1560002
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Huizhou, Kina, 516001
- Rekrytering
- Investigational Site Number : 1560026
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Shanghai, Kina, 200123
- Rekrytering
- Investigational Site Number : 1560020
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Wuxi, Kina, 214023
- Rekrytering
- Investigational Site Number : 1560018
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Kaunas, Litauen, LT-50161
- Rekrytering
- Investigational Site Number : 4400001
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Chisinau, Mögel, MD-2025
- Rekrytering
- Investigational Site Number : 4980003
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Chisinau, Mögel, MD-2025
- Rekrytering
- Investigational Site Number : 4980002
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Chisinau, Mögel, MD-2068
- Rekrytering
- Investigational Site Number : 4980004
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Tilburg, Nederländerna, 5022 GC
- Rekrytering
- Investigational Site Number : 5280003
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Lower Hutt, Nya Zeeland, 5010
- Rekrytering
- Investigational Site Number : 5540003
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Bydgoszcz, Polen, 85-229
- Rekrytering
- Investigational Site Number : 6160026
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Elblag, Polen, 82-300
- Rekrytering
- Investigational Site Number : 6160013
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Katowice, Polen, 40-748
- Rekrytering
- Investigational Site Number : 6160014
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Kłodzko, Polen, 57-300
- Rekrytering
- Investigational Site Number : 6160030
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Lublin, Polen, 20-049
- Rekrytering
- Investigational Site Number : 6160034
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Rzeszów, Polen, 35-326
- Rekrytering
- Investigational Site Number : 6160025
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Staszów, Polen, 28-200
- Rekrytering
- Investigational Site Number : 6160007
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Szczecin, Polen, 71-685
- Rekrytering
- Investigational Site Number : 6160020
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Torun, Polen, 87-100
- Rekrytering
- Investigational Site Number : 6160023
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Wadowice, Polen, 34-100
- Rekrytering
- Investigational Site Number : 6160012
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Warsaw, Polen, 04-501
- Rekrytering
- Investigational Site Number : 6160008
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Wroclaw, Polen, 52-416
- Rekrytering
- Investigational Site Number : 6160006
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Wroclaw, Polen, 54-239
- Rekrytering
- Investigational Site Number : 6160017
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Basel, Schweiz, CH-4058
- Rekrytering
- Investigational Site Number : 7560002
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Bern, Schweiz, 3012
- Rekrytering
- Investigational Site Number : 7560001
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Belgrade, Serbien, 11 080
- Rekrytering
- Investigational Site Number : 6880002
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Bratislava, Slovakien, 811 09
- Rekrytering
- Investigational Site Number : 7030001
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Cape Town, Sydafrika, 7405
- Rekrytering
- Investigational Site Number : 7100002
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Durban, Sydafrika, 3610
- Rekrytering
- Investigational Site Number : 7100004
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Kempton Park, Sydafrika, 1619
- Rekrytering
- Investigational Site Number : 7100001
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Busan, Sydkorea, 48108
- Rekrytering
- Investigational Site Number : 4100008
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Gwangju, Sydkorea, 61453
- Rekrytering
- Investigational Site Number : 4100007
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Seoul, Sydkorea, 6351
- Rekrytering
- Investigational Site Number : 4100006
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Seoul, Sydkorea, 6973
- Rekrytering
- Investigational Site Number : 4100002
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Changhua County, Taiwan, 500209
- Rekrytering
- Investigational Site Number : 1580005
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Hradec Králové, Tjeckien, 500 12
- Rekrytering
- Investigational Site Number: 2030011
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Prague, Tjeckien, 150 00
- Rekrytering
- Investigational Site Number : 2030013
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Baden-Wurttemberg
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Ulm, Baden-Wurttemberg, Tyskland, 89081
- Rekrytering
- Investigational Site Number : 2760005
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Saxony
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Leipzig, Saxony, Tyskland, 4103
- Rekrytering
- Investigational Site Number : 2760015
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, Tyskland, 24105
- Rekrytering
- Investigational Site Number : 2760001
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Kyiv, Ukraina, 2002
- Rekrytering
- Investigational Site Number : 8040001
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Kyiv, Ukraina, 2091
- Rekrytering
- Investigational Site Number : 8040013
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Lviv, Ukraina, 79000
- Rekrytering
- Investigational Site Number : 8040004
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Lviv, Ukraina, 79019
- Rekrytering
- Investigational Site Number : 8040005
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Uzhhorod, Ukraina, 88018
- Rekrytering
- Investigational Site Number : 8040006
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Vinnytsia, Ukraina, 21013
- Rekrytering
- Investigational Site Number : 8040010
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Vinnytsia, Ukraina, 21028
- Rekrytering
- Investigational Site Number : 8040009
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Vienna, Österrike, 1090
- Rekrytering
- Investigational Site Number : 0400001
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Placebo-jämförare: Placebo
SC injection as per protocol |
Pharmaceutical form:Injection solution-Route of administration:SC injection |
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Experimentell: Duvakitug dose 1
Subcutaneous (SC) injection as per protocol |
Pharmaceutical form:Injection solution-Route of administration:SC injection
Andra namn:
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Experimentell: Du vakitug dose 2
SC injection as per protocol |
Pharmaceutical form:Injection solution-Route of administration:SC injection
Andra namn:
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Experimentell: Du vakitug dose 3
SC injection as per protocol |
Pharmaceutical form:Injection solution-Route of administration:SC injection
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pivotalt underhållssubstudiekohort 1: Andel deltagare som uppnår magsårsfri endoskopi (i delmängden av deltagare med sår vid baslinjen) vid vecka 40
Tidsram: Vecka 40
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Vecka 40
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Pivotalt underhållssubstudiekohort 1: Förekomst av CD-relaterade sjukhusinläggning efter vecka 40
Tidsram: Vecka 0 till vecka 40
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Vecka 0 till vecka 40
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Pivotalt underhållssubstudiekohort 1: Serumkoncentrationer av Duvakitug mätt över tid
Tidsram: Vecka 0 till vecka 40
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Vecka 0 till vecka 40
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Pivotalt underhållssubstudiekohort 1: Förekomst av antikropp av behandlings-framstående antidrug (ADA) mot Duvakitug
Tidsram: Vecka 0 till vecka 40
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Vecka 0 till vecka 40
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Pivotalt underhåll Substudiekohort 1: Förekomst av behandlings-framstående biverkningar (TEAE), Tea av särskilt intresse (Teeses), TE-allvarliga biverkningar (TESAE) och TEAS som leder till permanent studieinterventionavbrott
Tidsram: Vecka 0 till 45 dagar efter sista dosen
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Vecka 0 till 45 dagar efter sista dosen
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Open-Label Extension Sub-Study: Incidens of Tees, Teeses, Tesaes och Teaesleading to Permanent Study Intervention Abontinuation
Tidsram: Vecka 40 av viktigt underhåll genom 45 dagar efter sista dosen
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Vecka 40 av viktigt underhåll genom 45 dagar efter sista dosen
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Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical response Week 40
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra studie-ID-nummer
- EFC18327
- 2025-521037-86 (Registeridentifierare: CTIS)
- U1111-1314-5471 (Registeridentifierare: ICTRP)
- 2025 (U.S.S. NIH-anslag/kontrakt)
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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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