En vedlikeholdsstudie for å undersøke effektiviteten og sikkerheten til Duvakitug hos deltakere med moderat til sterkt aktiv Crohns sykdom (STARSCAPE-2)
Et multisenter, multinasjonalt, randomisert, dobbeltblind, placebokontrollert fase 3, vedlikeholdsstudie for å evaluere effektiviteten og sikkerheten til duvakitug hos deltakere med moderat til alvorlig aktiv Crohns sykdom
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Trial Transparency email recommended (Toll free for US & Canada)
- Telefonnummer: option 6 800-633-1610
- E-post: Contact-US@sanofi.com
Studiesteder
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Salzburg, Australia, 5020
- Rekruttering
- Investigational Site Number : 0400002
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Vienna, Australia, 1190
- Rekruttering
- Investigational Site Number : 0400007
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Queensland
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South Brisbane, Queensland, Australia, 4101
- Rekruttering
- Investigational Site Number : 0360001
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Yvoir, Belgia, 5530
- Rekruttering
- Investigational Site Number : 0560003
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São José do Rio Preto, Brasil, 15090-000
- Rekruttering
- Sao Jose do Rio Preto Regional Faculty of Medicine Foundation-Site Number: 0760006
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Rousse, Bulgaria, 7000
- Rekruttering
- Investigational Site Number : 1000007
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Sofia, Bulgaria, 1618
- Rekruttering
- Investigational Site Number : 1000001
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Oblast Veliko Tirnovo
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Gorna Oryahovitsa, Oblast Veliko Tirnovo, Bulgaria, 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, Forente stater, 80907
- Rekruttering
- Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
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Florida
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Kissimmee, Florida, Forente stater, 34741
- Rekruttering
- Clinical Research of Osceola-Site Number: 8400013
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Miami, Florida, Forente stater, 33125
- Rekruttering
- Columbus Clinical Services LLc-Site Number: 8400038
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Miami, Florida, Forente stater, 33175
- Rekruttering
- Bioresearch Partner-Kendale Lakes-Site Number: 8400053
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Orlando, Florida, Forente stater, 32806
- Rekruttering
- Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084
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Tampa, Florida, Forente stater, 33607
- Rekruttering
- NMC Research LLC-Site Number: 8400033
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Illinois
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Gurnee, Illinois, Forente 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, Forente stater, 47150
- Rekruttering
- Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100
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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70809
- Rekruttering
- GI Alliance - Baton Rouge-Site Number: 8400129
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Mandeville, Louisiana, Forente stater, 70471
- Rekruttering
- Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128
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Metairie, Louisiana, Forente stater, 70006
- Rekruttering
- GI Alliance - Metairie-Site Number: 8400124
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Monroe, Louisiana, Forente stater, 71291
- Rekruttering
- Delta Research Partners-Site Number: 8400087
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Missouri
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Liberty, Missouri, Forente stater, 64068
- Rekruttering
- BVL Clinical Research-Site Number: 8400005
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St Louis, Missouri, Forente stater, 63141
- Rekruttering
- Gateway Gastroenterology-Site Number: 8400097
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New York
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Maspeth, New York, Forente stater, 11378
- Rekruttering
- MedTraits NY-Site Number: 8400045
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New York, New York, Forente stater, 10075
- Rekruttering
- New York Gastroenterology Associates-Site Number: 8400009
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New York, New York, Forente stater, 10016
- Rekruttering
- NYU Langone Health-Site Number: 8400091
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New York, New York, Forente 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, Forente stater, 27514
- Rekruttering
- UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074
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Fayetteville, North Carolina, Forente stater, 28304
- Rekruttering
- Cross Creek Medical Clinic-Site Number: 8400057
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Ohio
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Columbus, Ohio, Forente stater, 43202
- Rekruttering
- Ohio Gastroenterology Group Inc.-Site Number: 8400006
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Columbus, Ohio, Forente stater, 43210
- Rekruttering
- OSU Wexner Medical Center-Site Number: 8400077
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Columbus, Ohio, Forente stater, 43210
- Rekruttering
- Medical Associates Research Group-Site Number: 8400063
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Westlake, Ohio, Forente stater, 44145
- Rekruttering
- North Shore Gastroenterology Research-Site Number: 8400130
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104-6243
- Rekruttering
- University of Pennsylvania School of Medicine-Site Number: 8400072
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Pittsburgh, Pennsylvania, Forente 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, Forente stater, 02904
- Rekruttering
- University Gastroenterology - GI Alliance-Site Number: 8400103
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Texas
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Lubbock, Texas, Forente stater, 79410
- Rekruttering
- GI Alliance - Lubbock-Site Number: 8400092
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Mesquite, Texas, Forente stater, 75149
- Rekruttering
- SMS Clinical Research-Site Number: 8400035
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San Antonio, Texas, Forente stater, 78229
- Rekruttering
- Gastroenterology Research of San Antonio LLC-Site Number: 8400054
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Southlake, Texas, Forente stater, 76092
- Rekruttering
- Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake-Site Number: 8400101
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Tyler, Texas, Forente stater, 75701
- Rekruttering
- Tyler Research Institute LLC-Site Number: 8400095
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Washington
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Vancouver, Washington, Forente stater, 98664
- Rekruttering
- The Vancouver Clinic Inc. P.S.-Site Number: 8400090
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Wyoming
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Wyoming, Wyoming, Forente stater, 49519
- Rekruttering
- Gastroenterology Associates of Western Michigan-Site Number: 8400060
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Tbilisi, Georgia, 159
- Rekruttering
- Investigational Site Number : 2680003
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Tbilisi, Georgia, 180
- Rekruttering
- Investigational Site Number : 2680002
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Tbilisi, Georgia, 180
- Rekruttering
- Investigational Site Number : 2680004
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Tbilisi, Georgia, 102
- Rekruttering
- Investigational Site Number : 2680006
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Tbilisi, Georgia, 144
- Rekruttering
- Investigational Site Number : 2680008
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Tbilisi, Georgia, 160
- Rekruttering
- Investigational Site Number : 2680005
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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, Italia, 20089
- Rekruttering
- Investigational Site Number : 3800003
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Turin, Italia, 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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Tilburg, Nederland, 5022 GC
- Rekruttering
- Investigational Site Number : 5280003
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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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Belgrade, Serbia, 11 080
- Rekruttering
- Investigational Site Number : 6880002
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Bratislava, Slovakia, 811 09
- Rekruttering
- Investigational Site Number : 7030001
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Basel, Sveits, CH-4058
- Rekruttering
- Investigational Site Number : 7560002
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Bern, Sveits, 3012
- Rekruttering
- Investigational Site Number : 7560001
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Busan, Sør -Korea, 48108
- Rekruttering
- Investigational Site Number : 4100008
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Gwangju, Sør -Korea, 61453
- Rekruttering
- Investigational Site Number : 4100007
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Seoul, Sør -Korea, 6351
- Rekruttering
- Investigational Site Number : 4100006
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Seoul, Sør -Korea, 6973
- Rekruttering
- Investigational Site Number : 4100002
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Cape Town, Sør-Afrika, 7405
- Rekruttering
- Investigational Site Number : 7100002
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Durban, Sør-Afrika, 3610
- Rekruttering
- Investigational Site Number : 7100004
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Kempton Park, Sør-Afrika, 1619
- Rekruttering
- Investigational Site Number : 7100001
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Changhua County, Taiwan, 500209
- Rekruttering
- Investigational Site Number : 1580005
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Hradec Králové, Tsjekkia, 500 12
- Rekruttering
- Investigational Site Number: 2030011
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Prague, Tsjekkia, 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, Ukraina, 2002
- Rekruttering
- Investigational Site Number : 8040001
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Kyiv, Ukraina, 2091
- Rekruttering
- Investigational Site Number : 8040013
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Lviv, Ukraina, 79000
- Rekruttering
- Investigational Site Number : 8040004
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Lviv, Ukraina, 79019
- Rekruttering
- Investigational Site Number : 8040005
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Uzhhorod, Ukraina, 88018
- Rekruttering
- Investigational Site Number : 8040006
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Vinnytsia, Ukraina, 21013
- Rekruttering
- Investigational Site Number : 8040010
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Vinnytsia, Ukraina, 21028
- Rekruttering
- Investigational Site Number : 8040009
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Vienna, Østerrike, 1090
- Rekruttering
- Investigational Site Number : 0400001
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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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Eksperimentell: Duvakitug dose 1
Subcutaneous (SC) injection as per protocol |
Pharmaceutical form:Injection solution-Route of administration:SC injection
Andre navn:
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Eksperimentell: Du vakitug dose 2
SC injection as per protocol |
Pharmaceutical form:Injection solution-Route of administration:SC injection
Andre navn:
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Eksperimentell: Du vakitug dose 3
SC injection as per protocol |
Pharmaceutical form:Injection solution-Route of administration:SC injection
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pivotal vedlikeholdsunderstudium Kohort 1: Andel deltakere som oppnår magesårfri endoskopi (i delmengden av deltakere med magesår ved baseline) på uke 40
Tidsramme: Uke 40
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Uke 40
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Pivotal vedlikeholdsunderstudium Kohort 1: Forekomst av CD-relatert sykehusinnleggelse innen uke 40
Tidsramme: Uke 0 til uke 40
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Uke 0 til uke 40
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Pivotal vedlikeholdsunderstudium Kohort 1: Serumkonsentrasjoner av Duvakitug målt over tid
Tidsramme: Uke 0 til uke 40
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Uke 0 til uke 40
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Pivotal vedlikeholdsunderstudium Kohort 1: Forekomst av behandlingsoppførende antidrug Antistoff (ADA) mot Duvakitug
Tidsramme: Uke 0 til uke 40
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Uke 0 til uke 40
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Pivotal vedlikeholdsunderstudium Kohort 1: Forekomst av behandlingsoppførende bivirkninger (TEAE), TEA av spesiell interesse (teese), TE alvor
Tidsramme: Uke 0 til 45 dager etter siste dose
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Uke 0 til 45 dager etter siste dose
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Sub-studie med åpen label utvidelse: Forekomst av Teaes, Teaesis, Tesaes og Teaesleading til permanent studieintervensjon
Tidsramme: Uke 40 av sentralt vedlikehold gjennom 45 dager etter siste dose
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Uke 40 av sentralt vedlikehold gjennom 45 dager etter siste dose
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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
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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
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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Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EFC18327
- 2025-521037-86 (Registeridentifikator: CTIS)
- U1111-1314-5471 (Registeridentifikator: ICTRP)
- 2025 (U.S. NIH-stipend/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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Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .