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Een onderhoudsonderzoek om de werkzaamheid en veiligheid van Duvakitug te onderzoeken bij deelnemers met matig tot ernstig actieve ziekte van Crohn (STARSCAPE-2)

20 oktober 2026 bijgewerkt door: Sanofi

Een multicenter, multinationale, gerandomiseerde, dubbelblinde, placebo-gecontroleerde fase 3, onderhoudsstudie om de werkzaamheid en veiligheid van Duvakitug te evalueren bij deelnemers met matig tot ernstig actieve ziekte van Crohn

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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

751

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Trial Transparency email recommended (Toll free for US & Canada)
  • Telefoonnummer: option 6 800-633-1610
  • E-mail: Contact-US@sanofi.com

Studie Locaties

  • Australië
      • Salzburg, Australië, 5020
        • Werving
        • Investigational Site Number : 0400002
      • Vienna, Australië, 1190
        • Werving
        • Investigational Site Number : 0400007
    • Queensland
      • South Brisbane, Queensland, Australië, 4101
        • Werving
        • Investigational Site Number : 0360001
  • België
      • Yvoir, België, 5530
        • Werving
        • Investigational Site Number : 0560003
  • Brazilië
      • São José do Rio Preto, Brazilië, 15090-000
        • Werving
        • Sao Jose do Rio Preto Regional Faculty of Medicine Foundation-Site Number: 0760006
  • Bulgarije
      • Rousse, Bulgarije, 7000
        • Werving
        • Investigational Site Number : 1000007
      • Sofia, Bulgarije, 1618
        • Werving
        • Investigational Site Number : 1000001
    • Oblast Veliko Tirnovo
      • Gorna Oryahovitsa, Oblast Veliko Tirnovo, Bulgarije, 5100
        • Werving
        • Investigational Site Number : 1000003
  • Canada
      • Edmonton, Canada, T6G 2X8
        • Werving
        • Investigational Site Number : 1240004
      • Hamilton, Canada, L8N 1Y2
        • Werving
        • Investigational Site Number : 1240009
      • London, Canada, N6K 1M6
        • Werving
        • Investigational Site Number : 1240013
      • New Westminster, Canada, BC V3L 3W4
        • Werving
        • Investigational Site Number : 1240006
      • Toronto, Canada, M6A 3B4
        • Werving
        • Investigational Site Number : 1240003
  • Chili
      • Viña del Mar, Chili, 2540488
        • Werving
        • Investigational Site Number : 1520001
  • China
      • Guangzhou, China, 510655
        • Werving
        • Investigational Site Number : 1560002
      • Huizhou, China, 516001
        • Werving
        • Investigational Site Number : 1560026
      • Shanghai, China, 200123
        • Werving
        • Investigational Site Number : 1560020
      • Wuxi, China, 214023
        • Werving
        • Investigational Site Number : 1560018
  • Duitsland
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Duitsland, 89081
        • Werving
        • Investigational Site Number : 2760005
    • Saxony
      • Leipzig, Saxony, Duitsland, 4103
        • Werving
        • Investigational Site Number : 2760015
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Duitsland, 24105
        • Werving
        • Investigational Site Number : 2760001
  • Georgië
      • Tbilisi, Georgië, 159
        • Werving
        • Investigational Site Number : 2680003
      • Tbilisi, Georgië, 180
        • Werving
        • Investigational Site Number : 2680002
      • Tbilisi, Georgië, 180
        • Werving
        • Investigational Site Number : 2680004
      • Tbilisi, Georgië, 102
        • Werving
        • Investigational Site Number : 2680006
      • Tbilisi, Georgië, 144
        • Werving
        • Investigational Site Number : 2680008
      • Tbilisi, Georgië, 160
        • Werving
        • Investigational Site Number : 2680005
  • Israël
      • Jerusalem, Israël, 9103102
        • Werving
        • Investigational Site Number : 3760001
      • Tel Aviv, Israël, 6423906
        • Werving
        • Investigational Site Number : 3760002
  • Italië
      • Rozzano, Italië, 20089
        • Werving
        • Investigational Site Number : 3800003
      • Turin, Italië, 10128
        • Werving
        • Investigational Site Number : 3800005
  • Japan
      • Kamakura, Japan, 247-0056
        • Werving
        • Investigational Site Number : 3920030
      • Nishinomiya, Japan, 663-8501
        • Werving
        • Investigational Site Number : 3920013
      • Tsu, Japan, 514-8507
        • Werving
        • Investigational Site Number : 3920009
  • Litouwen
      • Kaunas, Litouwen, LT-50161
        • Werving
        • Investigational Site Number : 4400001
  • Moldavië
      • Chisinau, Moldavië, MD-2025
        • Werving
        • Investigational Site Number : 4980003
      • Chisinau, Moldavië, MD-2025
        • Werving
        • Investigational Site Number : 4980002
      • Chisinau, Moldavië, MD-2068
        • Werving
        • Investigational Site Number : 4980004
  • Nederland
      • Tilburg, Nederland, 5022 GC
        • Werving
        • Investigational Site Number : 5280003
  • Nieuw-Zeeland
      • Lower Hutt, Nieuw-Zeeland, 5010
        • Werving
        • Investigational Site Number : 5540003
  • Oekraïne
      • Kyiv, Oekraïne, 2002
        • Werving
        • Investigational Site Number : 8040001
      • Kyiv, Oekraïne, 2091
        • Werving
        • Investigational Site Number : 8040013
      • Lviv, Oekraïne, 79000
        • Werving
        • Investigational Site Number : 8040004
      • Lviv, Oekraïne, 79019
        • Werving
        • Investigational Site Number : 8040005
      • Uzhhorod, Oekraïne, 88018
        • Werving
        • Investigational Site Number : 8040006
      • Vinnytsia, Oekraïne, 21013
        • Werving
        • Investigational Site Number : 8040010
      • Vinnytsia, Oekraïne, 21028
        • Werving
        • Investigational Site Number : 8040009
  • Oostenrijk
      • Vienna, Oostenrijk, 1090
        • Werving
        • Investigational Site Number : 0400001
  • Polen
      • Bydgoszcz, Polen, 85-229
        • Werving
        • Investigational Site Number : 6160026
      • Elblag, Polen, 82-300
        • Werving
        • Investigational Site Number : 6160013
      • Katowice, Polen, 40-748
        • Werving
        • Investigational Site Number : 6160014
      • Kłodzko, Polen, 57-300
        • Werving
        • Investigational Site Number : 6160030
      • Lublin, Polen, 20-049
        • Werving
        • Investigational Site Number : 6160034
      • Rzeszów, Polen, 35-326
        • Werving
        • Investigational Site Number : 6160025
      • Staszów, Polen, 28-200
        • Werving
        • Investigational Site Number : 6160007
      • Szczecin, Polen, 71-685
        • Werving
        • Investigational Site Number : 6160020
      • Torun, Polen, 87-100
        • Werving
        • Investigational Site Number : 6160023
      • Wadowice, Polen, 34-100
        • Werving
        • Investigational Site Number : 6160012
      • Warsaw, Polen, 04-501
        • Werving
        • Investigational Site Number : 6160008
      • Wroclaw, Polen, 52-416
        • Werving
        • Investigational Site Number : 6160006
      • Wroclaw, Polen, 54-239
        • Werving
        • Investigational Site Number : 6160017
  • Servië
      • Belgrade, Servië, 11 080
        • Werving
        • Investigational Site Number : 6880002
  • Slowakije
      • Bratislava, Slowakije, 811 09
        • Werving
        • Investigational Site Number : 7030001
  • Taiwan
      • Changhua County, Taiwan, 500209
        • Werving
        • Investigational Site Number : 1580005
  • Tsjechië
      • Hradec Králové, Tsjechië, 500 12
        • Werving
        • Investigational Site Number: 2030011
      • Prague, Tsjechië, 150 00
        • Werving
        • Investigational Site Number : 2030013
  • Verenigde Staten
    • Colorado
      • Colorado Springs, Colorado, Verenigde Staten, 80907
        • Werving
        • Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
    • Florida
      • Kissimmee, Florida, Verenigde Staten, 34741
        • Werving
        • Clinical Research of Osceola-Site Number: 8400013
      • Miami, Florida, Verenigde Staten, 33125
        • Werving
        • Columbus Clinical Services LLc-Site Number: 8400038
      • Miami, Florida, Verenigde Staten, 33175
        • Werving
        • Bioresearch Partner-Kendale Lakes-Site Number: 8400053
      • Orlando, Florida, Verenigde Staten, 32806
        • Werving
        • Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084
      • Tampa, Florida, Verenigde Staten, 33607
        • Werving
        • NMC Research LLC-Site Number: 8400033
    • Illinois
      • Gurnee, Illinois, Verenigde Staten, 60031
        • Werving
        • Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee-Site Number: 8400049
    • Indiana
      • New Albany, Indiana, Verenigde Staten, 47150
        • Werving
        • Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100
    • Louisiana
      • Baton Rouge, Louisiana, Verenigde Staten, 70809
        • Werving
        • GI Alliance - Baton Rouge-Site Number: 8400129
      • Mandeville, Louisiana, Verenigde Staten, 70471
        • Werving
        • Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128
      • Metairie, Louisiana, Verenigde Staten, 70006
        • Werving
        • GI Alliance - Metairie-Site Number: 8400124
      • Monroe, Louisiana, Verenigde Staten, 71291
        • Werving
        • Delta Research Partners-Site Number: 8400087
    • Missouri
      • Liberty, Missouri, Verenigde Staten, 64068
        • Werving
        • BVL Clinical Research-Site Number: 8400005
      • St Louis, Missouri, Verenigde Staten, 63141
        • Werving
        • Gateway Gastroenterology-Site Number: 8400097
    • New York
      • Maspeth, New York, Verenigde Staten, 11378
        • Werving
        • MedTraits NY-Site Number: 8400045
      • New York, New York, Verenigde Staten, 10075
        • Werving
        • New York Gastroenterology Associates-Site Number: 8400009
      • New York, New York, Verenigde Staten, 10016
        • Werving
        • NYU Langone Health-Site Number: 8400091
      • New York, New York, Verenigde Staten, 10065
        • Werving
        • Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27514
        • Werving
        • UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074
      • Fayetteville, North Carolina, Verenigde Staten, 28304
        • Werving
        • Cross Creek Medical Clinic-Site Number: 8400057
    • Ohio
      • Columbus, Ohio, Verenigde Staten, 43202
        • Werving
        • Ohio Gastroenterology Group Inc.-Site Number: 8400006
      • Columbus, Ohio, Verenigde Staten, 43210
        • Werving
        • OSU Wexner Medical Center-Site Number: 8400077
      • Columbus, Ohio, Verenigde Staten, 43210
        • Werving
        • Medical Associates Research Group-Site Number: 8400063
      • Westlake, Ohio, Verenigde Staten, 44145
        • Werving
        • North Shore Gastroenterology Research-Site Number: 8400130
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104-6243
        • Werving
        • University of Pennsylvania School of Medicine-Site Number: 8400072
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15212
        • Werving
        • The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107
    • Rhode Island
      • Providence, Rhode Island, Verenigde Staten, 02904
        • Werving
        • University Gastroenterology - GI Alliance-Site Number: 8400103
    • Texas
      • Lubbock, Texas, Verenigde Staten, 79410
        • Werving
        • GI Alliance - Lubbock-Site Number: 8400092
      • Mesquite, Texas, Verenigde Staten, 75149
        • Werving
        • SMS Clinical Research-Site Number: 8400035
      • San Antonio, Texas, Verenigde Staten, 78229
        • Werving
        • Gastroenterology Research of San Antonio LLC-Site Number: 8400054
      • Southlake, Texas, Verenigde Staten, 76092
        • Werving
        • Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake-Site Number: 8400101
      • Tyler, Texas, Verenigde Staten, 75701
        • Werving
        • Tyler Research Institute LLC-Site Number: 8400095
    • Washington
      • Vancouver, Washington, Verenigde Staten, 98664
        • Werving
        • The Vancouver Clinic Inc. P.S.-Site Number: 8400090
    • Wyoming
      • Wyoming, Wyoming, Verenigde Staten, 49519
        • Werving
        • Gastroenterology Associates of Western Michigan-Site Number: 8400060
  • Zuid -Korea
      • Busan, Zuid -Korea, 48108
        • Werving
        • Investigational Site Number : 4100008
      • Gwangju, Zuid -Korea, 61453
        • Werving
        • Investigational Site Number : 4100007
      • Seoul, Zuid -Korea, 6351
        • Werving
        • Investigational Site Number : 4100006
      • Seoul, Zuid -Korea, 6973
        • Werving
        • Investigational Site Number : 4100002
  • Zuid-Afrika
      • Cape Town, Zuid-Afrika, 7405
        • Werving
        • Investigational Site Number : 7100002
      • Durban, Zuid-Afrika, 3610
        • Werving
        • Investigational Site Number : 7100004
      • Kempton Park, Zuid-Afrika, 1619
        • Werving
        • Investigational Site Number : 7100001
  • Zwitserland
      • Basel, Zwitserland, CH-4058
        • Werving
        • Investigational Site Number : 7560002
      • Bern, Zwitserland, 3012
        • Werving
        • Investigational Site Number : 7560001

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

16 jaar tot 80 jaar (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo

SC injection as per protocol
Geneesmiddel: Placebo

Pharmaceutical form:Injection solution-Route of administration:SC injection
Experimenteel: Duvakitug dose 1

Subcutaneous (SC) injection as per protocol
Geneesmiddel: Duvakitug

Pharmaceutical form:Injection solution-Route of administration:SC injection

Andere namen:
  • SAR447189
Experimenteel: Du vakitug dose 2

SC injection as per protocol
Geneesmiddel: Duvakitug

Pharmaceutical form:Injection solution-Route of administration:SC injection

Andere namen:
  • SAR447189
Experimenteel: Du vakitug dose 3

SC injection as per protocol
Geneesmiddel: Duvakitug

Pharmaceutical form:Injection solution-Route of administration:SC injection

Andere namen:
  • SAR447189

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission (CDAI) at Week 40
Tijdsspanne: Week 40

Clinical Remission by Crohn's Disease Activity Index (CDAI): CDAI score <150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease.
Week 40
Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40
Tijdsspanne: Week 40

The SES-CD is a standardized method for evaluating disease activity. Score ranges from 0 to 56, where higher scores represent more severe disease. Endoscopic Response by SES-CD is a decrease in SES-CD ≥50% from Baseline (or a decrease of at least 2 points for participants with a Baseline score of 4 or more, and isolated ileal disease) based on central reading.
Week 40
Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission per PRO-2 at Week 40
Tijdsspanne: Week 40

Clinical Remission 2-item patient-reported outcome (PRO-2): average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline.
Week 40

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pivotal Maintenance Sub-Study Cohort 1: aandeel deelnemers dat zweervrije endoscopie bereikt (in de subset van deelnemers met zweren bij aanvang) in week 40
Tijdsspanne: Week 40
Week 40
Pivotal Maintenance Sub-Study Cohort 1: Incidentie van CD-gerelateerde ziekenhuisopname per week 40
Tijdsspanne: Week 0 tot en met week 40
Week 0 tot en met week 40
Pivotal Maintenance Sub-Study Cohort 1: Serumconcentraties van Duvakitug gemeten in de loop van de tijd
Tijdsspanne: Week 0 tot en met week 40
Week 0 tot en met week 40
Pivotaal onderhoud Substudie Cohort 1: Incidentie van behandelings-opkomende antidrug-antilichaam (ADA) tegen Duvakitug
Tijdsspanne: Week 0 tot en met week 40
Week 0 tot en met week 40
Pivotaal onderhoud Substudie Cohort 1: Incidentie van bijwerkingen voor behandelingsopkomst (TEEAS), TEE van speciale interesse (teaese), TE-ernstige bijwerkingen (TESAE's) en TEEA's die leiden tot stopzetting van de permanente studie-interventie
Tijdsspanne: Week 0 tot en met 45 dagen na de laatste dosis
Week 0 tot en met 45 dagen na de laatste dosis
Open-label extensie Substudie: incidentie van Tea, Teese, TESAES en TeeEeSleading to Permanente Study Intervention Discontinuatie
Tijdsspanne: Week 40 van cruciaal onderhoud gedurende 45 dagen na de laatste dosis
Week 40 van cruciaal onderhoud gedurende 45 dagen na de laatste dosis
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical response Week 40
Tijdsspanne: Week 40

The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease. Clinical Response by CDAI: decrease in CDAI score of 100 points or more from Baseline.
Week 40
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving SES-CD endoscopic remission at Week 40
Tijdsspanne: Week 40

The SES-CD is a standardized method for evaluating disease activity. Score ranges from 0 to 56, where higher scores represent more severe disease. Endoscopic 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
US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission and endoscopic remission at Week 40
Tijdsspanne: 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
EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission and endoscopic remission at Week 40
Tijdsspanne: Week 40

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
US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission at Week 40
Tijdsspanne: Week 40

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
EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission at Week 40
Tijdsspanne: Week 40

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
US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free CDAI clinical remission at Week 40
Tijdsspanne: Week 40

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
EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free PRO-2 remission at Week 40
Tijdsspanne: Week 40

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
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)
Tijdsspanne: Week 40

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
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)
Tijdsspanne: Week 40

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
Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in PROMIS-Fatigue Short Form 7a T-score at Week 40
Tijdsspanne: Baseline, Week 40

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
Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in IBDQ total score at Week 40
Tijdsspanne: Baseline, Week 40

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
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no bowel urgency by NRS at Week 40
Tijdsspanne: Week 40

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Sanofi

Medewerkers

Teva Branded Pharmaceutical Products R&D LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

22 januari 2026

Primaire voltooiing (Geschat)

13 augustus 2029

Studie voltooiing (Geschat)

20 maart 2034

Studieregistratiedata

Eerst ingediend

15 september 2025

Eerst ingediend dat voldeed aan de QC-criteria

15 september 2025

Eerst geplaatst (Werkelijk)

22 september 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

20 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • EFC18327
  • 2025-521037-86 (Register-ID: CTIS)
  • U1111-1314-5471 (Register-ID: ICTRP)
  • 2025 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren