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Eine Studie zur Untersuchung der Wirksamkeit und Sicherheit von SAR441566 bei Patienten mit Colitis ulcerosa (SPECIFI-UC)

16. Oktober 2026 aktualisiert von: Sanofi

A Phase 2, multinationale, multizentrische, randomisierte, doppelblinde, placebokontrollierte, dosisberufliche Studie zur Bewertung der Wirksamkeit und Sicherheit von SAR441566 bei Erwachsenen mit mittelschwerer bis schwerer ulcerosa Colitis

This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis.

This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment.

Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants (for participants not enrolling in the LTS study).

  • The study duration will be up to 59 weeks.
  • The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm.
  • The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

170

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Argentinien
      • Buenos Aires, Argentinien, 1061
        • Investigational Site Number : 0320001
      • Buenos Aires, Argentinien, 1006
        • Investigational Site Number : 0320003
      • Buenos Aires, Argentinien, 1023
        • Investigational Site Number : 0320002
      • Buenos Aires, Argentinien, 1125
        • Investigational Site Number : 0320005
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentinien, 4000
        • Investigational Site Number : 0320004
  • Australien
    • South Australia
      • Kurralta Park, South Australia, Australien, 5037
        • Investigational Site Number : 0360003
    • Victoria
      • Richmond, Victoria, Australien, 3121
        • Investigational Site Number : 0360005
  • Belgien
      • Ghent, Belgien, 9000
        • Investigational Site Number : 0560002
      • Leuven, Belgien, 3000
        • Investigational Site Number : 0560001
  • Brasilien
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90035903
        • Hospital de Clinicas de Porto Alegre- Site Number : 0760002
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90160-093
        • Hospital Ernesto Dornelles- Site Number : 0760003
  • Bulgarien
      • Burgas, Bulgarien, 8000
        • Investigational Site Number : 1000001
      • Rousse, Bulgarien, 7002
        • Investigational Site Number : 1000003
      • Sofia, Bulgarien, 1612
        • Investigational Site Number : 1000002
  • Chile
    • Reg Metropolitana de Santiago
      • Santiago, Reg Metropolitana de Santiago, Chile, 8330034
        • Investigational Site Number : 1520003
      • Santiago, Reg Metropolitana de Santiago, Chile, 7500010
        • Investigational Site Number : 1520002
      • Santiago, Reg Metropolitana de Santiago, Chile, 8331143
        • Investigational Site Number : 1520001
  • China
      • Guangzhou, China, 510655
        • Investigational Site Number : 1560002
      • Hangzhou, China, 310016
        • Investigational Site Number : 1560001
      • Huizhou, China, 516001
        • Investigational Site Number : 1560003
      • Huizhou, China, 516001
        • Investigational Site Number : 1560017
      • Jiazhuang, China, 050000
        • Investigational Site Number : 1560004
      • Linhai, China, 317000
        • Investigational Site Number : 1560014
      • Luoyang, China, 471003
        • Investigational Site Number : 1560008
      • Shanghai, China, 200120
        • Investigational Site Number : 1560005
      • Wuhan, China, 430014
        • Investigational Site Number : 1560011
  • Deutschland
      • Berlin, Deutschland, 10117
        • Investigational Site Number : 2760005
      • Berlin, Deutschland, 14050
        • Investigational Site Number : 2760008
      • Duisburg, Deutschland, 47055
        • Investigational Site Number : 2760010
      • Frankfurt, Deutschland, 60590
        • Investigational Site Number : 2760009
      • Hanover, Deutschland, 30625
        • Investigational Site Number : 2760003
      • Tübingen, Deutschland, 72076
        • Investigational Site Number : 2760011
      • Ulm, Deutschland, 89081
        • Investigational Site Number : 2760006
  • Frankreich
      • Nice, Frankreich, 06202
        • Investigational Site Number : 2500003
      • Toulouse, Frankreich, 31059
        • Investigational Site Number : 2500001
      • Vandœuvre-lès-Nancy, Frankreich, 54511
        • Investigational Site Number : 2500002
  • Georgia
      • Tbilisi, Georgia, 0160
        • Investigational Site Number : 2680003
      • Tbilisi, Georgia, 0144
        • Investigational Site Number : 2680002
      • Tbilisi, Georgia, 0180
        • Investigational Site Number : 2680001
  • Griechenland
      • Athens, Griechenland, 124 62
        • Investigational Site Number : 3000003
      • Athens, Griechenland, 106 76
        • Investigational Site Number : 3000001
      • Heraklion, Griechenland, 711 10
        • Investigational Site Number : 3000002
  • Indien
      • Hyderabad, Indien, 500082
        • Investigational Site Number : 3560005
      • Jaipur, Indien, 302001
        • Investigational Site Number : 3560003
      • Jaipur, Indien, 302004
        • Investigational Site Number : 3560009
      • Kolkata, Indien, 700020
        • Investigational Site Number : 3560002
      • Ludhiana, Indien, 141002
        • Investigational Site Number : 3560004
      • Secunderabad, Indien, 500003
        • Investigational Site Number : 3560007
      • Surat, Indien, 395002
        • Investigational Site Number : 3560001
      • Visakhapatnam, Indien, 530040
        • Investigational Site Number : 3560010
  • Italien
      • Alessandria, Italien, 15100
        • Investigational Site Number : 3800007
      • Palermo, Italien, 90127
        • Investigational Site Number : 3800009
      • Pisa, Italien, 56124
        • Investigational Site Number : 3800004
    • Genova
      • Genoa, Genova, Italien, 16132
        • Investigational Site Number : 3800006
    • Milano
      • Milan, Milano, Italien, 20132
        • Investigational Site Number : 3800002
      • Rozzano, Milano, Italien, 20089
        • Investigational Site Number : 3800003
    • Napoli
      • Naples, Napoli, Italien, 80131
        • Investigational Site Number : 3800008
    • Padova
      • Padua, Padova, Italien, 35128
        • Investigational Site Number : 3800001
    • Roma
      • Rome, Roma, Italien, 00161
        • Investigational Site Number : 3800011
    • Torino
      • Turin, Torino, Italien, 10126
        • Investigational Site Number : 3800010
  • Japan
      • Hiroshima, Japan, 734-8530
        • Investigational Site Number : 3920012
      • Kagoshima, Japan, 892-0843
        • Investigational Site Number : 3920016
      • Niigata, Japan, 950-1104
        • Investigational Site Number : 3920001
      • Osaka, Japan, 530-0011
        • Investigational Site Number : 3920010
      • Tokyo, Japan, 108-8642
        • Investigational Site Number : 3920015
    • Chiba
      • Kashiwa, Chiba, Japan, 277-0871
        • Investigational Site Number : 3920005
    • Hiroshima
      • Kure, Hiroshima, Japan, 737-0811
        • Investigational Site Number : 3920014
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 004-0041
        • Investigational Site Number : 3920003
      • Sapporo, Hokkaido, Japan, 065-0033
        • Investigational Site Number : 3920007
    • Iwate
      • Yahaba, Iwate, Japan, 028-3695
        • Investigational Site Number : 3920009
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 220-0041
        • Investigational Site Number : 3920013
    • Tokyo
      • Bunkyo-Ku, Tokyo, Japan, 113-8510
        • Investigational Site Number : 3920002
      • Kodaira, Tokyo, Japan, 187-8510
        • Investigational Site Number : 3920011
    • Yamanashi
      • Kofu, Yamanashi, Japan, 400-0027
        • Investigational Site Number : 3920006
  • Kanada
    • Nova Scotia
      • Kentville, Nova Scotia, Kanada, B4N 0A3
        • Investigational Site Number : 1240004
    • Ontario
      • Ajax, Ontario, Kanada, L1S 7K7
        • Investigational Site Number : 1240006
      • Richmond Hill, Ontario, Kanada, L4C 9M7
        • Investigational Site Number : 1240005
    • Quebec
      • Québec, Quebec, Kanada, G1N 4V3
        • Investigational Site Number : 1240001
  • Kroatien
      • Osijek, Kroatien, 31000
        • Investigational Site Number : 1910001
  • Polen
    • Lesser Poland Voivodeship
      • Oświęcim, Lesser Poland Voivodeship, Polen, 32-600
        • Investigational Site Number : 6160008
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Polen, 53-034
        • Investigational Site Number : 6160005
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 03-580
        • Investigational Site Number : 6160004
      • Warsaw, Masovian Voivodeship, Polen, 04-501
        • Investigational Site Number : 6160001
    • Podkarpackie Voivodeship
      • Rzeszów, Podkarpackie Voivodeship, Polen, 35-055
        • Investigational Site Number : 6160002
  • Rumänien
      • Constanța, Rumänien, 900673
        • Investigational Site Number : 6420001
  • Südafrika
      • Cape Town, Südafrika, 7405
        • Investigational Site Number : 7100002
      • Cape Town, Südafrika, 7708
        • Investigational Site Number : 7100001
      • KwaDukuza, Südafrika, 4449
        • Investigational Site Number : 7100004
      • Pretoria, Südafrika, 0157
        • Investigational Site Number : 7100005
      • Pretoria, Südafrika, 0002
        • Investigational Site Number : 7100003
  • Tschechien
      • Olomouc, Tschechien, 779 00
        • Investigational Site Number : 2030001
      • Ostrava, Tschechien, 710 00
        • Investigational Site Number : 2030002
  • Türkei (türkiye)
      • Istanbul, Türkei (türkiye), 34899
        • Investigational Site Number : 7920002
      • Izmir, Türkei (türkiye), 35100
        • Investigational Site Number : 7920003
      • Mersin, Türkei (türkiye), 33070
        • Investigational Site Number : 7920001
  • Ungarn
      • Budapest, Ungarn
        • Investigational Site Number : 3480001
  • Vereinigte Staaten
    • Arizona
      • Sun City, Arizona, Vereinigte Staaten, 85351
        • GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003
    • Connecticut
      • Bristol, Connecticut, Vereinigte Staaten, 06010
        • Bristol Hospital- Site Number : 8400017
    • Florida
      • Clermont, Florida, Vereinigte Staaten, 34711
        • Novum Research- Site Number : 8400018
      • Kissimmee, Florida, Vereinigte Staaten, 34741
        • Clinical Research of Osceola- Site Number : 8400012
      • Miami Lakes, Florida, Vereinigte Staaten, 33016
        • Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002
      • Tampa, Florida, Vereinigte Staaten, 33609
        • GCP Clinical Research- Site Number : 8400016
    • Illinois
      • Glenview, Illinois, Vereinigte Staaten, 60026
        • GI Alliance - Glenview- Site Number : 8400005
      • Gurnee, Illinois, Vereinigte Staaten, 60031
        • Illinois Gastroenterology Group- Site Number : 8400004
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48109
        • University of Michigan Health System - Ann Arbor- Site Number : 8400010
    • New York
      • New York, New York, Vereinigte Staaten, 10029
        • Icahn School of Medicine at Mount Sinai- Site Number : 8400001
      • Queens Village, New York, Vereinigte Staaten, 11428
        • Queens Village Primary Medical Center- Site Number : 8400011
    • Ohio
      • Lima, Ohio, Vereinigte Staaten, 45805
        • NexGen Research- Site Number : 8400020
    • Pennsylvania
      • Uniontown, Pennsylvania, Vereinigte Staaten, 15401
        • Frontier Clinical Research - Uniontown- Site Number : 8400006
    • South Carolina
      • Charleston, South Carolina, Vereinigte Staaten, 29401
        • Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400008
    • Texas
      • Katy, Texas, Vereinigte Staaten, 77494
        • Gastro Health & Nutrition- Site Number : 8400007
      • Lubbock, Texas, Vereinigte Staaten, 79424
        • SI Research Associates- Site Number : 8400019
      • Southlake, Texas, Vereinigte Staaten, 76092
        • Texas Digestive Disease Consultants - Southlake- Site Number : 8400015
    • Washington
      • Seattle, Washington, Vereinigte Staaten, 98195
        • University of Washington Medical Center- Site Number : 8400014
      • Tacoma, Washington, Vereinigte Staaten, 98405
        • Washington Gastroenterology - Tacoma- Site Number : 8400009
  • Österreich
      • Salzburg, Österreich, 5020
        • Investigational Site Number : 0400002
      • Vienna, Österreich, 1090
        • Investigational Site Number : 0400001

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

  • Male or female participants aged 18 to 75 years inclusive, at the time of signing the informed consent

  • Participants who have clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period

  • Active moderate-to-severe UC at screening as defined by a modified Mayo Score (mMS) of 5 to 9 (without the Physician global Assessment (PGA), with a minimum rectal bleeding (RB) subscore ≥1, a minimum stool frequency (SF) subscore ≥1, a mMES ≥2 confirmed by central reader, a minimum sum of all subscores of 5, and a disease extent >15 cm from the anal verge

  • Must have received prior treatment for UC (either "a" or "b" below or a combination of both "a" and "b"):

    1. History of no prior exposure to approved Advanced Therapy (AT), but having inadequate response to, loss of response to or intolerance to standard treatment with any of the following : 5-ASA, thiopurines (eg.6-MP, AZA), MTX, oral or intravenous (IV) corticosteroids or history of corticosteroid dependence (defined an inability to successfully taper corticosteroids without recurrence of UC) OR
    2. History of inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent (eg. TNF antagonists, anti-integrin other than natalizumab, anti-IL-12/23, anti-IL-23, or a small molecule (such as a JAKi or S1PRm) for UC

  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Participants with active CD, indeterminate colitis, ischemic colitis, microscopic colitis
  • Participants with the following ongoing known complications of UC: fulminant colitis, toxic megacolon, or any other manifestation that might require bowel surgery while enrolled in the study
  • Participant with prior colectomy, ostomy or ileoanal pouch, or anticipated colectomy during their participation in the study
  • Participants with fecal sample positive for ova or parasites, bacterial pathogens, or positive for Clostridium difficile B toxin in stools
  • Participants with active tuberculosis (TB) or a history of incompletely treated active TB or latent TB infection per local guidelines
  • Participants with Positive Hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) and/or hepatitis C virus antibody (HCVAb) at the screening visit
  • Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex
  • Participants with a known history of human immunodeficiency virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening
  • Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening
  • History of gastro-intestinal dysplasia other than completely removed low grade dysplasia OR presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during endoscopy by the time of the screening visit.
  • If the participant has extensive colitis for ≥8 years or disease limited to left side of colon (ie, distal to splenic flexure) for >10 years, regardless of age, a colonoscopy within 1 year of the screening visit is required to survey for dysplasia. Participants with dysplasia or cancer identified on biopsies will be excluded.
  • Female participants who is pregnant, breastfeeding, or is considering becoming pregnant during the study or within 3 months after the last dose of study drug
  • Infection(s) requiring treatment with IV anti-infectives within 30 days prior to the screening visit or oral/intramuscular anti-infectives within 14 days prior to the screening visit
  • Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition
  • Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening
  • Participants who received fecal microbial transplantation within 30 days prior to screening
  • Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
  • Participants who received IV corticosteroids within 14 days prior to screening or during screening period
  • Screening laboratory and other analyses show abnormal results.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: SAR441566 dose regimen 1

Participants will receive SAR441566 dose regimen 1
Arzneimittel: SAR441566

Pharmaceutical form: Tablet Route of administration: Oral
Experimental: SAR441566 dose regimen 2

Participants will receive SAR441566 dose regimen 2
Arzneimittel: SAR441566

Pharmaceutical form: Tablet Route of administration: Oral
Experimental: SAR441566 dose regimen 3

Participants will receive SAR441566 dose regimen 3
Arzneimittel: SAR441566

Pharmaceutical form: Tablet Route of administration: Oral
Placebo-Komparator: Placebo

Participants will receive SAR441566-matching placebo
Arzneimittel: SAR441566 matching Placebo

Pharmaceutical form: Tablet Route of administration: Oral

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of participants achieving clinical remission at Week 12 by modified Mayo Score (mMS)
Zeitfenster: Week 12

Clinical remission by modified Mayo score (mMS) is defined as a mMS ≤2 with no subscore >1 (stool frequency [SF] of 0 or 1 with at least a 1-point decrease from baseline, rectal bleeding [RB] of 0 and modified Mayo Endoscopic Subscore [mMES] of 0 or 1 where 1 does not include friability).

Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity.
Week 12

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Plasma -Prädosekonzentrationen von SAR441566 bei ausgewählten Besuchen
Zeitfenster: Bis zur Woche 52
Bis zur Woche 52
Plasmakonzentrationen von SAR441566 bei ausgewählten Besuchen
Zeitfenster: Bis zur Woche 52
Bis zur Woche 52
Anzahl der Teilnehmer mit jeglichen Behandlungsveranstaltungsveranstaltungen (TEAEs) während der Induktions- und Erhaltungsbehandlungsperiode
Zeitfenster: Bis zur Woche 52
Bis zur Woche 52
Anzahl der Teilnehmer mit jeglichen Behandlungsveranstaltungen (TEAEs) während der Aufbereitungszeit mit offener Label
Zeitfenster: Von Woche 12 bis Woche 52
Von Woche 12 bis Woche 52
Proportion of participants achieving clinical response at Week 12 by modified Mayo Score (mMS)
Zeitfenster: Week 12

Clinical response by modified Mayo score (mMS) is defined as a decrease from baseline in the mMS of ≥2 points and an improvement of ≥30% from baseline plus a decrease in rectal bleeding (RB) subscore ≥1 or an absolute RB subscore ≤1.

Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity.
Week 12
Proportion of participants achieving clinical response at Week 12 by full Mayo score (MS)
Zeitfenster: Week 12

Clinical response by full Mayo score (MS) is defined as a decrease from baseline in the MS of ≥3 points and an improvement of ≥30% from baseline plus a decrease in rectal bleeding (RB) subscore ≥1 or an absolute RB subscore ≤1.

The MS (also referred to as the full Mayo Score) is a composite index designed to measure ulcerative colitis (UC) disease activity and consists of 4 subscores: RB and SF, which are patient-reported subscores, Physician's global assessment (PGA), and endoscopic findings. Individual items are rated 0 to 3, giving the composite score a maximum of 12, with higher scores indicating greater disease severity.
Week 12
Proportion of participants achieving clinical remission at Week 12 by full Mayo score (MS)
Zeitfenster: Week 12

Clinical remission by full Mayo score (MS) is defined as a MS ≤2 with no score >1.
Week 12
Proportion of participants achieving the combination of patient-reported outcome 2 (PRO2) remission and endoscopic remission at Week 12
Zeitfenster: Week 12

Patient-reported outcome 2 (PRO2) remission is defined as PRO2 score ≤1 with rectal bleeding (RB) of 0, and endoscopic remission is defined as mMES of 0.

PRO2 score is defined as the sum of Mayo SF and RB subscores.
Week 12
Proportion of participants achieving endoscopic remission at Week 12
Zeitfenster: Week 12

Endoscopic remission is defined as mMES of 0.
Week 12
Change from baseline in PRO2 from randomization to Week 12
Zeitfenster: From Baseline to Week 12

PRO2 score is defined as the sum of the Mayo SF and RB subscores.
From Baseline to Week 12
Proportion of participants achieving endoscopic response at Week 12
Zeitfenster: Week 12

Endoscopic response is defined as mMES decrease of at least 1 point.
Week 12
Proportion of participants achieving endoscopic improvement at Week 12
Zeitfenster: Week 12

Endoscopic improvement is defined as mMES of 0 or 1 where 1 does not include friability.
Week 12
Proportion of participants achieving HEMI at Week 12
Zeitfenster: Week 12

Histologic endoscopic mucosal improvement (HEMI) is defined by achievement of modified Mayo endoscopic improvement (mMES of 0 or 1 where 1 does not include friability) and histological improvement (original Geboes Score [OGS] ≤3.1).
Week 12
Proportion achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 12
Zeitfenster: Week 12

Inflammatory Bowel Disease Questionnaire (IBDQ) remission is considered as an IBDQ-32 total score ≥170 points.

IBDQ is designed to capture the patient's experience of IBD on 4 domains of functioning and well-being: bowel and systemic symptoms and emotional and social function. The total IBDQ score ranges from 32 to 224 which indicates better quality of life.
Week 12
Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) response at Week 12
Zeitfenster: Week 12

Inflammatory Bowel Disease Questionnaire (IBDQ) response is defined as an increase from baseline in the total IBDQ score in the range of 16 to 32 points.
Week 12

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Sanofi

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

28. März 2025

Primärer Abschluss (Tatsächlich)

6. August 2026

Studienabschluss (Tatsächlich)

12. Oktober 2026

Studienanmeldedaten

Zuerst eingereicht

4. März 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. März 2025

Zuerst gepostet (Tatsächlich)

10. März 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • DRI17822
  • U1111-1308-9729 (Andere Kennung: WHO)
  • 2025-520705-12 (Registrierungskennung: CTIS)
  • 2025 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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