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En undersøgelse af vedolizumab hos børn og teenagere med moderat til svær colitis ulcerosa (UC)

9. april 2026 opdateret af: Takeda

Et randomiseret, dobbeltblindt fase 3-studie til evaluering af effektiviteten og sikkerheden af ​​Vedolizumab intravenøst ​​som vedligeholdelsesterapi hos pædiatriske forsøgspersoner med moderat til svær aktiv colitis ulcerosa, som opnåede klinisk respons efter open-label vedolizumab intravenøs terapi

Vedolizumab er et lægemiddel, der hjælper med at reducere betændelse og smerter i fordøjelsessystemet. I denne undersøgelse vil børn og teenagere med moderat til svær colitis ulcerosa blive behandlet med vedolizumab.

Hovedformålet med undersøgelsen er at kontrollere, om deltagerne opnår remission efter behandling med vedolizumab. Remission betyder, at symptomerne forbedres eller forsvinder, og en endoskopi viser ingen eller begrænsede tegn på sygdom.

Deltagerne vil modtage 3 infusioner af vedolizumab over 6 uger. Derefter vil de, der har et klinisk respons, modtage 1 ud af 3 doser vedolizumab en gang hver 8. uge. De vil modtage den samme dosis hver gang.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Lægemidlet, der testes i denne undersøgelse, kaldes vedolizumab. Vedolizumab testes til behandling af pædiatriske deltagere, som har moderat til svært aktiv UC. Deltagere, der skal tilmeldes, skal have svigtet respons på, mistet respons på eller været intolerante over for mindst 1 af de nuværende standardbehandlinger (SOC) induktions- og vedligeholdelsesterapier for CD inklusive eksklusiv og/eller delvis enteral ernæringsterapi, immunmodulatorer (f.eks. azathioprin [AZA], 6-mercaptopurin [6-MP], methotrexat [MTX]) og tumornekrosefaktor-alfa (TNF-α) antagonister.

Undersøgelsen vil omfatte cirka 120 patienter.

I løbet af induktionsperioden vil deltagerne modtage 3 doser vedolizumab IV-infusion på dag 1, uge ​​2 og uge 6 baseret på deres vægt ved baseline:

  • Deltagere ≥30 kg, Vedolizumab 300 mg
  • Deltagere >15 til
  • Deltagere 10 til 15 kg, Vedolizumab 150 mg

I uge 14 vil deltagere, der opnår klinisk respons, blive tilfældigt tildelt (tilfældigt, som at slå en mønt) i et 1:1-forhold til 2 dobbeltblindede dosisgrupper (høj dosis og lav dosis), stratificeret efter tidligere eksponering/manglende TNF-a-antagonister-terapi eller naive til TNF-a-antagonister-terapi, og efter vægtgruppe. Deltagerne vil modtage vedolizumab IV-infusioner hver 8. uge (Q8W) op til uge 46 i vedligeholdelsesperioden som følger:

  • Deltagere ≥30 kg, Vedolizumab 300 mg (høj dosis)
  • Deltagere ≥30 kg, Vedolizumab 150 mg (lav dosis)
  • Deltagere >15 til
  • Deltagere >15 til
  • Deltagere 10 til 15 kg, Vedolizumab 150 mg (høj dosis)
  • Deltagere 10 til 15 kg, Vedolizumab 100 mg (lav dosis)

Dosis forbliver blindet for deltageren og undersøgelseslægen under undersøgelsen (medmindre der er et akut medicinsk behov). Alle deltagere vil blive administreret vedolizumab via IV-infusion. Hos deltagere, der viser manglende vedligeholdelse af klinisk respons i vedligeholdelsesperioden, vil dosis blive eskaleret på en blind måde baseret på vægten på tidspunktet for forværring af sygdommen. Derudover er engangsredningsbehandling med kortikosteroider tilladt.

Dette multicenterforsøg vil blive gennemført over hele verden. Efter uge 54 kan deltagerne være berettiget til at deltage i forlængelsesstudiet. Deltagere, der ikke ruller over i forlængelsesstudiet, vil gennemgå et sikkerhedsbesøg 18 uger efter den sidste dosis vedolizumab efterfulgt af 2 års langtidsopfølgning (op til 104 uger). I denne periode vil der blive udført en sikkerhedsundersøgelse telefonisk hver 6. måned i 2 år efter den sidste dosis af forsøgslægemidlet.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

121

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
    • New South Wales
      • Westmead, New South Wales, Australien, 2145
        • Children's Hospital at Westmead
    • Queensland
      • South Brisbane, Queensland, Australien, 4101
        • Queensland Childrens Hospital
    • Victoria
      • Clayton, Victoria, Australien, 3168
        • Monash Health, Monash Medical Centre
      • Parkville, Victoria, Australien, 3052
        • Royal Children's Hospital Melbourne - PIN
  • Belgien
    • Antwerpen
      • Edegem, Antwerpen, Belgien, 2650
        • UZ Antwerpen
    • Brussels Capital
      • Jette, Brussels Capital, Belgien, 1090
        • Universitair Ziekenhuis Brussel - PIN
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgien, 3000
        • Universitaire Ziekenhuizen(UZ)Leuven-Campus Gasthuisberg
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2S2
        • University of Alberta Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • British Columbia Children's Hospital
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre
  • Det Forenede Kongerige
      • Cardiff, Det Forenede Kongerige, CF14 4XW
        • Noahs Ark Childrens Hospital for Wales
    • London, City of
      • London, London, City of, Det Forenede Kongerige, E1 1BB
        • The Royal London Hospital
      • London, London, City of, Det Forenede Kongerige, WC1N 3JH
        • Great Ormond Street Hospital
    • West Midlands
      • Birmingham, West Midlands, Det Forenede Kongerige, B4 6NH
        • Birmingham Women's and Children's NHS Foundation Trust
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85016-7710
        • Phoenix Childrens Hospital -1919 E Thompson Rd
    • California
      • San Diego, California, Forenede Stater, 92123
        • Rady Childrens Hospital San Diego - PIN
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30318-4833
        • Childrens Center For Digestive Healthcare
    • Illinois
      • Park Ridge, Illinois, Forenede Stater, 60068
        • Advocate Children's Hospital Park Ridge
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Boston Children's Hospital
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55413
        • MNGI Digestive Health PA-Plymouth
      • Rochester, Minnesota, Forenede Stater, 55905-0001
        • Mayo Clinic - PIN
    • New Jersey
      • Morristown, New Jersey, Forenede Stater, 07960-6136
        • Goryeb Children's Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224-1334
        • UPMC Children's Hospital of Pittsburgh-120 Lytton Ave
    • Texas
      • Houston, Texas, Forenede Stater, 77030-2358
        • Texas Childrens Hospital West Campus
    • Virginia
      • Roanoke, Virginia, Forenede Stater, 24013-2253
        • Carilion Children's Tanglewood Center
  • Grækenland
      • Thessaloniki, Grækenland, 546 42
        • Ippokratio General Hospital of Thessaloniki
    • Attica
      • Athens, Attica, Grækenland, 115 27
        • Children's Hospital "Agia Sofia"
      • Chaïdári, Attica, Grækenland, 124 62
        • Attikon University General Hospital
  • Israel
      • Haifa, Israel, 3436212
        • Carmel Medical Center
      • Haifa, Israel, 31096
        • Rambam Medical Center - PPDS
      • Petah Tikva, Israel, 49100
        • Schneider Childrens Medical Center of Israel Petah Tikvah PIN
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center
      • Jerusalem, Jerusalem, Israel, 91120
        • Hadassah Medical Center - PPDS
  • Italien
      • Naples, Italien, 280138
        • AOU dell'Universita degli Studi della Campania Luigi Vanvitelli - Piazza Luigi Miraglia, 2
    • Campania
      • Naples, Campania, Italien, 80131
        • Azienda Ospedaliera Universitaria Federico II
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italien, 40133
        • Azienda USL di Bologna
    • Lazio
      • Rome, Lazio, Italien, 00161
        • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
    • Monza E Brianza
      • Monza, Monza E Brianza, Italien, 20900
        • Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza A. O. San Gerardo
    • Tuscany
      • Florence, Tuscany, Italien, 50139
        • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
  • Japan
      • Kumamoto, Japan, 861-8520
        • Japanese Red Cross Kumamoto Hospital
      • Saitama, Japan, 330-8777
        • Saitama Children's Medical Center
    • Hukuoka
      • Kurume, Hukuoka, Japan, 830-0011
        • Kurume University Hospital
    • Tokyo
      • Bunkyo-Ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital
      • Setagaya-ku, Tokyo, Japan, 157-8535
        • National Center for Child Health and Development
  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100045
        • Beijing Children's Hospital, Capital Medical University - PIN
    • Henan
      • Zhengzhou, Henan, Kina, 450000
        • Henan Children's Hospital Zhengzhou Children's Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 201102
        • Children's Hospital of Fudan University
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310003
        • The Children's Hospital Zhejiang University School of Medicine
  • Kroatien
    • City of Zagreb
      • Zagreb, City of Zagreb, Kroatien, 10000
        • Klinika Za Djecje Bolesti Zagreb
  • Polen
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polen, 30-663
        • Uniwersytecki Szpital Dziecięcy
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 00-728
        • WIP Warsaw IBD Point Profesor Kierkus
      • Warsaw, Masovian Voivodeship, Polen, 04-736
        • Instytut 'Pomnik - Centrum Zdrowia Dziecka'
    • Podkarpackie Voivodeship
      • Rzeszów, Podkarpackie Voivodeship, Polen, 35-302
        • Korczowski Bartosz, Gabinet Lekarski
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Polen, 40-752
        • Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Polen, 71-434
        • Twoja Przychodnia SCM
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Polen, 91-738
        • SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251
      • Lodz, Łódź Voivodeship, Polen, 93-338
        • Instytut Centrum Zdrowia Matki Polki
  • Sydkorea
    • Daegu Gwang'yeogsi
      • Daegu, Daegu Gwang'yeogsi, Sydkorea, 41404
        • Kyungpook National University Chilgok Hospital
    • Incheon Gwang'yeogsi
      • Seoul, Incheon Gwang'yeogsi, Sydkorea, 3080
        • Gachon University Gil Medical Center
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Sydkorea, 06351
        • Samsung Medical Center
      • Seoul, Seoul Teugbyeolsi, Sydkorea, 21565
        • Seoul National University Hospital
  • Ungarn
      • Budapest, Ungarn, 1085
        • Semmelweis Egyetem
      • Budapest, Ungarn, 1033
        • Clinexpert Gyogycentrum
      • Miskolc, Ungarn, 3526
        • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

2 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Har moderat til svært aktiv UC, reagerer ikke eller intolererer deres nuværende standard for pleje (SOC).
  2. Vejer ≥10 kg på tidspunktet for screening og optagelse i undersøgelsen.
  3. Har moderat til svær aktiv UC diagnosticeret mindst 1 måned før screening, defineret ved en modificeret Mayo-score på 5 til 9 (summen af ​​Mayo endoskopisk subscore, afføringsfrekvens subscore og rektal blødning subscore) med en Mayo endoskopisk subscore på ≥2 (med tilstedeværelsen af ​​slimhindesprødhed, eksklusive en endoskopisk subscore 1 og kræver en score på mindst 2).
  4. Har svigtet, mistet respons på eller været intolerant over for behandling med mindst 1 af følgende midler: kortikosteroider (f.eks. azathioprin [AZA], 6-mercaptopurin [6-MP], methotrexat [MTX]), immunmodulatorer og/eller tumor necrosis factor alfa (TNF-α) antagonistterapi (f.eks. infliximab, adalimumab). Dette omfatter deltagere, der er afhængige af kortikosteroider for at kontrollere symptomer, og som oplever forværring af sygdommen i moderat til svær rækkevidde, når de forsøger at afvænne kortikosteroider.
  5. Har tegn på UC, der som minimum strækker sig proksimalt til endetarmen (dvs. ikke begrænset til proctitis).
  6. Har omfattende colitis eller pancolitis af >8 års varighed eller venstresidet colitis af >12 års varighed skal der inden for 12 måneder før screening være dokumenteret dokumentation for negativ overvågningskoloskopi.
  7. Deltagere med vaccinationer, der er opdaterede baseret på det landsdækkende, accepterede skema for børnevacciner.

Ekskluderingskriterier:

  1. Har tidligere været udsat for godkendte eller undersøgelsesmæssige antiintegriner, herunder, men ikke begrænset til, natalizumab, efalizumab, etrolizumab eller Abrilumab (AMG 181), eller mucosal addressin celleadhæsionsmolekyle-1 (MAdCAM-1) antagonister eller rituximab.
  2. Har modtaget et biologisk forsøgslægemiddel inden for 60 dage eller 5 halveringstider før screening (alt efter hvad der er længst); eller et godkendt biologisk eller biosimilært middel inden for 2 uger før den første dosis af forsøgslægemidlet eller på et hvilket som helst tidspunkt i screeningsperioden.
  3. Har aktiv cerebral/meningeal sygdom, tegn/symptomer eller historie med progressiv multifokal leukoencefalopati (PML) eller andre større neurologiske lidelser, herunder slagtilfælde, multipel sklerose, hjernetumor eller neurodegenerativ sygdom.
  4. Har haft klinisk signifikant infektion (f.eks. lungebetændelse, pyelonefritis, coronavirus sygdom 2019 [COVID-19]) inden for 30 dage før første dosis af undersøgelseslægemidlet.
  5. Har modtaget levende vaccinationer inden for 30 dage før første dosis af undersøgelseslægemidlet.
  6. Deltagere, der i øjeblikket har behov for kirurgisk indgreb eller forventes at kræve kirurgisk indgreb for UC i løbet af denne undersøgelse.
  7. Har haft subtotal eller total kolektomi eller har en jejunostomi, ileostomi, kolostomi, ileo-anal pose eller kendt fast stenose i tarmen.
  8. Deltagere med en aktuel diagnose af ubestemt colitis.
  9. Deltagere med kliniske træk, der tyder på monogen, meget tidligt opstået inflammatorisk tarmsygdom.

  10. Deltager med aktiv eller latent tuberkulose (TB), som påvist af en diagnostisk TB-test udført inden for 30 dage efter screening eller i screeningsperioden, der er positiv, defineret som:

    • Positiv QuantiFERON-test eller 2 på hinanden følgende ubestemte QuantiFERON-tests, ELLER
    • En TB-hudtestreaktion ≥5 mm. BEMÆRK: Hvis deltagerne har modtaget Bacillus Calmette-Guérin-vaccine, skal der udføres en QuantiFERON TB Gold-test i stedet for TB-hudtesten.

  11. Har kronisk hepatitis B-virus (HBV)-infektion* eller kronisk hepatitis C-virusinfektion.

    • HBV-immune deltagere (dvs. er hepatitis B overfladeantigen negative og hepatitis B antistof positive) kan dog inkluderes.
  12. Deltageren har tegn på dysplasi eller anden malignitet i anamnesen end et vellykket behandlet ikke-metastatisk kutant pladecelle- eller basalcellecarcinom eller lokaliseret carcinom in situ af livmoderhalsen.
  13. Har positive afføringsundersøgelser for æg og/eller parasitter eller afføringskultur ved screeningsbesøg.
  14. Har positiv Clostridium difficile afføringstest ved screeningsbesøg.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Vedligeholdelsesperiode: Deltagere ≥30 kg, Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, én gang hver 8. uge (Q8W) fra uge 14 op til uge 46 i vedligeholdelsesperioden. Deltagere med uge 14 vægt på ≥30 kg, som opnåede klinisk respons i uge 14 randomiseret til denne højdosis armgruppe, vil modtage vedolizumab 300 mg.
Medicin: Vedolizumab
Vedolizumab IV infusion.
Andre navne:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Eksperimentel: Vedligeholdelsesperiode: Deltagere ≥30 kg, Vedolizumab 150 mg
Vedolizumab 150 mg, IV infusion, Q8W fra uge 14 op til uge 46 i vedligeholdelsesperioden. Deltagere med uge 14 vægt på ≥30 kg, som opnåede klinisk respons i uge 14 randomiseret til denne lavdosis armgruppe, vil modtage vedolizumab 150 mg.
Medicin: Vedolizumab
Vedolizumab IV infusion.
Andre navne:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Eksperimentel: Vedligeholdelsesperiode: Deltagere >15 til
Vedolizumab 200 mg, IV infusion, Q8W fra uge 14 op til uge 46 i vedligeholdelsesperioden. Deltagere med uge 14 vægt på >15 til
Medicin: Vedolizumab
Vedolizumab IV infusion.
Andre navne:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Eksperimentel: Vedligeholdelsesperiode: Deltagere >15 til
Vedolizumab 100 mg, IV infusion, Q8W fra uge 14 op til uge 46 i vedligeholdelsesperioden. Deltagere med uge 14 vægt på >15 til
Medicin: Vedolizumab
Vedolizumab IV infusion.
Andre navne:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Eksperimentel: Vedligeholdelsesperiode: Deltagere 10 til 15 kg, Vedolizumab 150 mg
Vedolizumab 150 mg, IV infusion, Q8W fra uge 14 op til uge 46 i vedligeholdelsesperioden. Deltagere med uge 14 vægt på 10 til 15 kg, som opnåede klinisk respons i uge 14 randomiseret til denne højdosis armgruppe, vil modtage vedolizumab 150 mg.
Medicin: Vedolizumab
Vedolizumab IV infusion.
Andre navne:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Eksperimentel: Vedligeholdelsesperiode: Deltagere 10 til 15 kg, Vedolizumab 100 mg
Vedolizumab 100 mg, IV infusion, Q8W fra uge 14 op til uge 46 i vedligeholdelsesperioden. Deltagere med uge 14 vægt på 10 til 15 kg, som opnåede klinisk respons i uge 14 randomiseret til denne lavdosis armgruppe, vil modtage vedolizumab 100 mg.
Medicin: Vedolizumab
Vedolizumab IV infusion.
Andre navne:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Eksperimentel: Induktionsperiode: Deltagere ≥30 kg, Vedolizumab 300 mg
Vedolizumab 300 mg, intravenøs (IV) infusion, på dag 1, uge ​​2 og 6 i induktionsperioden. Deltagere med UC med en baselinevægt på ≥30 kg er inkluderet i denne arm.
Medicin: Vedolizumab
Vedolizumab IV infusion.
Andre navne:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Eksperimentel: Induktionsperiode: Deltagere >15 til <30 kg, Vedolizumab 200 mg
Vedolizumab 200 mg, IV infusion, på dag 1, uge ​​2 og 6 i induktionsperioden. Deltagere med UC med baselinevægt på >15 til <30 kg er inkluderet i denne arm.
Medicin: Vedolizumab
Vedolizumab IV infusion.
Andre navne:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Eksperimentel: Induktionsperiode: Deltagere 10 til 15 kg, Vedolizumab 150 mg
Vedolizumab 150 mg, IV infusion, på dag 1, uge ​​2 og 6 i induktionsperioden. Deltagere med UC med en baselinevægt på 10 til 15 kg er inkluderet i denne arm.
Medicin: Vedolizumab
Vedolizumab IV infusion.
Andre navne:
  • MLN0002
  • ENTYVIO
  • KYNTELES

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Clinical Remission at Week 54 Based on Modified Mayo Score
Tidsramme: At Week 54
Clinical remission based on the modified Mayo score was defined as stool frequency sub score 0 to 1 and a decrease of 1 or more from baseline, rectal bleeding sub score of 0, and endoscopy sub score 0 to 1 (modified so that a score of 1 does not include friability) and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy). Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease.
At Week 54

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Clinical Remission at Week 14 Based on Modified Mayo Score
Tidsramme: At Week 14
Clinical remission based on the modified Mayo score was defined as stool frequency sub score 0 to 1 and a decrease of 1 or more from baseline, rectal bleeding sub score of 0, and endoscopy sub score 0 to 1 (modified so that a score of 1 does not include friability) and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy. Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease.
At Week 14
Percentage of Participants With Sustained Clinical Remission at Week 54 Based on Modified Mayo Score
Tidsramme: At Week 54
Participants who had clinical remission at Week 14 were analyzed for sustained clinical remission at Week 54. Clinical remission based on the modified Mayo score was defined as stool frequency sub score 0 to 1 and a decrease of 1 or more from baseline, rectal bleeding sub score of 0, and endoscopy sub score 0 to 1 (modified so that a score of 1 does not include friability) and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy. Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease.
At Week 54
Percentage of Participants With Sustained Endoscopic Remission at Week 54
Tidsramme: At Week 54
Participants who had endoscopic remission at Week 14 were analyzed for sustained endoscopic remission at Week 54. Mayo endoscopic sub score (MES) was a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale was graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher score indicated more severe disease.
At Week 54
Percentage of Participants With Endoscopic Response at Week 14
Tidsramme: At Week 14
Endoscopic response was defined as a decrease from baseline in the MES >=1 point. MES was a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale was graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher score indicated more severe disease.
At Week 14
Percentage of Participants With Endoscopic Response at Week 54
Tidsramme: At Week 54
Endoscopic response was defined as a decrease from baseline in the MES >=1 point. MES was a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale was graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher score indicated more severe disease.
At Week 54
Percentage of Participants With Corticosteroid-free Clinical Remission at Week 54
Tidsramme: At Week 54
Corticosteroid-free clinical remission based on the modified Mayo score was defined as when a participant meets the definition described in the primary endpoint and was off corticosteroids at least 12 weeks prior to and at Week 54 and without presence of any intercurrent event. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy. Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease.
At Week 54
Percentage of Participants With Clinical Remission at Week 54 Based on Complete Mayo Score
Tidsramme: At Week 54
Clinical remission based on complete Mayo score was a score (inclusive of physician global assessment [PGA]) of <=2 points with no individual sub score >1 and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Complete Mayo score was a composite index of 4 disease activity variables (stool frequency, rectal bleeding, endoscopy [modified so that a score of 1 does not include friability], and PGA sub scores) ranging from 0-12. Higher score indicated more severe disease.
At Week 54
Serum Trough Concentrations of Vedolizumab Over Time
Tidsramme: Predose at Week 14 and post dose at Week 54
Serum trough concentration of vedolizumab was reported.
Predose at Week 14 and post dose at Week 54
Percentage of Participants With Positive Anti-vedolizumab Antibodies (AVA)
Tidsramme: Up to Week 54
AVA positive was defined as a confirmed AVA positive result.
Up to Week 54
Percentage of Participants With Positive Neutralizing AVA
Tidsramme: Up to Week 54
Positive Neutralizing AVA was defined as a positive result in the neutralizing AVA assay at any visit.
Up to Week 54
Percentage of Participants With Sustained Clinical Response at Week 54 Based on Complete Mayo Score
Tidsramme: At Week 54
Participants who had clinical response at Week 14 were analyzed for sustained clinical response at Week 54. Sustained refers to meeting the specific endpoint criteria at both Week 14 and Week 54. Sustained clinical response is defined as meeting the following criteria at both Week 14 and Week 54: reduction in complete Mayo score of >=3 points and >=30% from baseline with an accompanying decrease in rectal bleeding sub score of >=1 point or absolute rectal bleeding sub score of <=1 point. Mayo score was an instrument designed to measure disease activity of UC. Complete Mayo score was a composite index of 4 disease activity variables (stool frequency, rectal bleeding, endoscopy [modified so that a score of 1 does not include friability], and PGA sub scores) ranging from 0-12. Higher score indicated more severe disease.
At Week 54
Percentage of Participants With Clinical Response up to Week 54 Based on Partial Mayo Score
Tidsramme: At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Clinical response was where a participant achieved clinical response if they had a reduction of >=2 points and >=25% from the baseline partial Mayo score, including a >=1 point decrease in the Mayo stool frequency sub score and a >=1 point reduction in the rectal bleeding sub score or absolute rectal bleeding sub score of <=1 point. Mayo score was an instrument designed to measure disease activity of UC. A partial Mayo score was defined as composite index of 3 disease activity variables (stool frequency, rectal bleeding, and PGA sub scores) that ranged from 0-9 and excluded the endoscopy sub score. Higher score indicates more severe disease.
At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Percentage of Participants With Clinical Remission up to Week 54 Based on Partial Mayo Score
Tidsramme: At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Clinical remission based on partial Mayo score was defined as a partial Mayo score of <=2 points and no individual sub score >1 point. Mayo score was an instrument designed to measure disease activity of UC. A partial Mayo score was defined as composite index of 3 disease activity variables (stool frequency, rectal bleeding, and PGA sub scores) that ranged from 0-9 and excluded the endoscopy sub score. Higher score indicates more severe disease.
At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Percentage of Participants With at Least One Treatment Emergent Adverse Event (TEAE), Treatment Emergent Serious Adverse Event (TESAE), and Adverse Event of Special Interest (AESI)
Tidsramme: From first dose of study drug up to end of follow up (up to 3.7 years)
A TEAE was defined as an AE whose date of onset occurred on or after the first dose of study drug through Week 54 for participants entering the extension study or the final safety visit 18 weeks after their last dose of study drug for those who do not enter the extension study or those who early terminate. A TESAE was defined as an undesirable event that was not present prior to medical treatment or an already present event that worsened either in intensity or frequency following the first dose of study drug, that occurred from the first dose of study drug to the day of last dose of study drug + 126 days. AESI was defined as an AE (serious or nonserious) of medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor was appropriate. AESIs include infusion-related reactions and hypersensitivity, serious infection, malignancy, or other (liver injury and progressive multifocal leukoencephalopathy [PML]).
From first dose of study drug up to end of follow up (up to 3.7 years)
Change From Baseline in Weight
Tidsramme: At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Change from baseline in weight was reported.
At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Change From Baseline in Weight Z-score
Tidsramme: At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Change from baseline in weight Z-score was reported. Weight z-score expresses how an individual's measured weight compares to the expected weight of a reference population of the same age and sex, standardized using population growth charts. It represents the number of standard deviations (SDs) an individual's weight is above or below the mean of the reference population. Z-score was calculated as: Z-score = (observed value - median value of the reference population) / standard deviation value of reference population. A Z-score of 0 represents the mean of the reference population. A negative Z-score indicates that the observed value is below (lower than) the reference mean, while a positive Z-score indicates that the observed value is above (higher than) the reference mean.
At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Change From Baseline in Height
Tidsramme: At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Change from baseline in height was reported.
At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Change From Baseline in Linear Growth Z-score
Tidsramme: At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Change from baseline in linear growth Z-score were reported. Linear growth Z-score is a standardized measure that describes how far a measured height deviates from the median height of a reference population of the same age and sex based on established growth charts. It is expressed in units of standard deviations (SD). Z-score was calculated as: Z-score = (observed value - median value of the reference population) / standard deviation value of reference population. A Z-score of 0 represents the mean of the reference population. A negative Z-score indicates that the observed value is below (lower than) the reference mean, while a positive Z-score indicates that the observed value is above (higher than) the reference mean.
At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Number of Participants With Change From Baseline in Tanner Stage at Week 54
Tidsramme: At Week 54
Tanner stages are used to evaluate growth parameters. They are standardized for age, sex, and pubertal development, with Stage 1 representing the prepubertal stage and Stage 5 representing the fully mature adult stage. It measures Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). The data reported shows shifts in participants' Tanner stages from baseline to Week 54.
At Week 54

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Takeda

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. oktober 2021

Primær færdiggørelse (Faktiske)

1. juli 2025

Studieafslutning (Faktiske)

1. juli 2025

Datoer for studieregistrering

Først indsendt

1. marts 2021

Først indsendt, der opfyldte QC-kriterier

1. marts 2021

Først opslået (Faktiske)

3. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. april 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MLN0002-3024
  • 2020-004300-34 (EudraCT nummer)
  • jRCT2071210030 (Registry Identifier: jRCT)
  • 2023-509018-12-00 (Ctis)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Takeda giver adgang til de afidentificerede individuelle deltagerdata (IPD) for kvalificerede undersøgelser for at hjælpe kvalificerede forskere med at løse legitime videnskabelige mål (Takedas tilsagn om datadeling er tilgængelig på https://clinicaltrials.takeda.com/takedas-commitment?commitment= 5). Disse IPD'er vil blive leveret i et sikkert forskningsmiljø efter godkendelse af en anmodning om datadeling og under betingelserne i en datadelingsaftale.

IPD-delingsadgangskriterier

IPD fra kvalificerede undersøgelser vil blive delt med kvalificerede forskere i henhold til kriterierne og processen beskrevet på https://vivli.org/ourmember/takeda/. For godkendte anmodninger vil forskerne få adgang til anonymiserede data (for at respektere patientens privatliv i overensstemmelse med gældende love og regler) og med oplysninger, der er nødvendige for at opfylde forskningsmålene i henhold til vilkårene i en datadelingsaftale.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Colitis, Ulcerativ

Kliniske forsøg med Vedolizumab

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Gambia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner