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Tutkimus SAR441566: n tehokkuuden ja turvallisuuden tutkimiseksi potilailla, joilla on haavainen koliitti (SPECIFI-UC)

perjantai 16. lokakuuta 2026 päivittänyt: Sanofi

Vaihe 2, monikansallinen, monikeskus, satunnaistettu, kaksoissokkoutettu, lumelääkekontrolloitu, annospohjainen tutkimus SAR441566: n tehokkuuden ja turvallisuuden arvioimiseksi aikuisilla, joilla on kohtalainen tai vaikea haavainen koliitti

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.

Tutkimuksen yleiskatsaus

Tila

Lopetettu

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

170

Vaihe

  • Vaihe 2

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 75 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Nelinkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: SAR441566 dose regimen 1

Participants will receive SAR441566 dose regimen 1
Lääke: SAR441566

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

Participants will receive SAR441566 dose regimen 2
Lääke: SAR441566

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

Participants will receive SAR441566 dose regimen 3
Lääke: SAR441566

Pharmaceutical form: Tablet Route of administration: Oral
Placebo Comparator: Placebo

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

Pharmaceutical form: Tablet Route of administration: Oral

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Proportion of participants achieving clinical remission at Week 12 by modified Mayo Score (mMS)
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
SAR441566: n plasman ennalta pitoisuudet valituilla vierailuilla
Aikaikkuna: Viikko 52 asti
Viikko 52 asti
SAR441566: n plasman postiannoksen pitoisuudet valituilla vierailuilla
Aikaikkuna: Viikko 52 asti
Viikko 52 asti
Osallistujien lukumäärä, joilla on kaikki hoitoon liittyvät haittavaikutukset (TEAT) induktio- ja ylläpitohoitojakson aikana
Aikaikkuna: Viikko 52 asti
Viikko 52 asti
Osallistujien lukumäärä, joilla on kaikki hoitoon liittyvät haittavaikutukset (TEAES) avoimeen käsittelyjakson aikana
Aikaikkuna: Viikosta 12 viikkoon 52
Viikosta 12 viikkoon 52
Proportion of participants achieving clinical response at Week 12 by modified Mayo Score (mMS)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Week 12

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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Sanofi

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Perjantai 28. maaliskuuta 2025

Ensisijainen valmistuminen (Todellinen)

Torstai 6. elokuuta 2026

Opintojen valmistuminen (Todellinen)

Maanantai 12. lokakuuta 2026

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 4. maaliskuuta 2025

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 4. maaliskuuta 2025

Ensimmäinen Lähetetty (Todellinen)

Maanantai 10. maaliskuuta 2025

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 21. lokakuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 16. lokakuuta 2026

Viimeksi vahvistettu

Torstai 1. lokakuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • DRI17822
  • U1111-1308-9729 (Muu tunniste: WHO)
  • 2025-520705-12 (Rekisterin tunniste: CTIS)
  • 2025 (Yhdysvaltain NIH-apuraha/sopimus)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

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