Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

10. november 2014 opdateret af: Pfizer

A Phase 2a, Randomized, Double-blind, Sponsor Unblinded, Placebo-controlled, Multiple Dose Study To Evaluate The Pharmacodynamics, Pharmacokinetics And Safety Of Anrukinzumab In Subjects With Active Ulcerative Colitis

This study represents the first investigation of anrukinzumab in patients with active ulcerative colitis (UC) and will evaluate proof of mechanism by changes in the mechanism based biomarker (YKL 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and hs-CRP). It will provide further assessment of the safety, tolerability, and pharmacokinetics (PK) by administration of multiple intravenous (IV) doses of anrukinzumab.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

84

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Bulgarien
      • Ruse, Bulgarien, 7002
        • MBAL Ruse / MHAT Ruse, Terapevtichno, gastroenterologichno i hematologichno otdelenie
      • Sofia, Bulgarien, 1606
        • MBAL Voennomeditsinska Akademia / MMA HAT, Klinika po gastroenterologia i hepatologia
      • Sofia, Bulgarien, 1750
        • DKTs Sveta Anna, Gastroenterologichen cabinet
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Heritage Medical Research Clinic - University Of Calgary
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver Coastal Health - Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital - The Gordon and Leslie Diamond Centre
    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
        • The Religious Hospitallers of St. Joseph of the Hotel Dieu of Kingston
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35249
        • UAB Hospital Department of Pharmacy
      • Birmingham, Alabama, Forenede Stater, 35233
        • UAB Hospital
      • Birmingham, Alabama, Forenede Stater, 35233
        • The Kirkland Clinic
      • Birmingham, Alabama, Forenede Stater, 35294
        • Administrative Offices
      • Birmingham, Alabama, Forenede Stater, 35294
        • UAB ACIP
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85013
        • Dedicated Phase I, Inc.
      • Phoenix, Arizona, Forenede Stater, 85006
        • Arizona Surgical Center
    • California
      • Anaheim, California, Forenede Stater, 92801
        • Anaheim Clinical Trials, LLC
      • Anaheim, California, Forenede Stater, 92801
        • AGMG Endoscopy Center
      • Santa Ana, California, Forenede Stater, 92705
        • West Coast Radiology Center
    • Connecticut
      • Hamden, Connecticut, Forenede Stater, 06518
        • Medical Research Center of Connecticut, LLC
      • Hamden, Connecticut, Forenede Stater, 06518
        • Gastroenterology Center of Connecticut, PC
      • Hamden, Connecticut, Forenede Stater, 06518
        • Endoscopy Center of Connecticut, LLC
    • Florida
      • Sanford, Florida, Forenede Stater, 32771
        • International Clinical Research - US, LLC
    • Georgia
      • Marietta, Georgia, Forenede Stater, 30060
        • Gastrointestinal Specialists of Georgia, PC
      • Marietta, Georgia, Forenede Stater, 30067
        • GI Diagnostics
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216
        • St. Dominic Hospital
      • Jackson, Mississippi, Forenede Stater, 39202
        • Gastrointestinal Associates, PA
      • Jackson, Mississippi, Forenede Stater, 39202
        • Gastrointestional Associates, PA
      • Tupelo, Mississippi, Forenede Stater, 38801
        • North Mississippi Medical Center
      • Tupelo, Mississippi, Forenede Stater, 38801
        • Digestive Health Specialists, PA
    • New York
      • Poughkeepsie, New York, Forenede Stater, 12601
        • Premier Medical Group of the Hudson Valley
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • PMG Research of Winston-Salem
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Piedmont Gastroenterology Specialists
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • University Hospitals Case Medical Center - Division of Gastroenterology and Liver Disease
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Oklahoma Foundation for Digestive Research
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • OU Physicians Building
      • Oklahoma City, Oklahoma, Forenede Stater, 73103
        • Wheeler and Stuckey, Inc.
    • Tennessee
      • Germantown, Tennessee, Forenede Stater, 38138
        • Memphis Gastroenterology Group, PC
      • Memphis, Tennessee, Forenede Stater, 38120
        • The West Clinic
      • Nashville, Tennessee, Forenede Stater, 37203
        • Centennial Medical Center Physicians Park
      • Nashville, Tennessee, Forenede Stater, 37203
        • Centennial Medical Center Tower Medical Imaging
      • Nashville, Tennessee, Forenede Stater, 37203
        • Columbia Medical Group - The First Clinic Inc.
      • Nashville, Tennessee, Forenede Stater, 37203
        • Radiology Alliance
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Professional Quality Research, Inc.
      • Austin, Texas, Forenede Stater, 78757
        • Austin Endoscopy Center
      • Austin, Texas, Forenede Stater, 78757
        • Austin Gastroenterology, PA
      • Houston, Texas, Forenede Stater, 77081
        • Texas Center for Drug Development, Inc.
      • Round Rocks, Texas, Forenede Stater, 78681
        • Austin Gastroenterology, PA
      • San Antonio, Texas, Forenede Stater, 78229
        • Cardiology Clinic of San Antonio
      • San Antonio, Texas, Forenede Stater, 78229
        • Gastroenterology Research of San Antonio
      • San Antonio, Texas, Forenede Stater, 78229
        • San Antonio Endoscopy Center
    • Utah
      • Murray, Utah, Forenede Stater, 84123
        • CNS Pharmacy
      • Salt Lake City, Utah, Forenede Stater, 84132
        • University of Utah Hospital
      • Salt Lake City, Utah, Forenede Stater, 84102
        • Alpine Medical Group
      • Salt Lake City, Utah, Forenede Stater, 84107
        • Wasatch Clinical Research
      • Salt Lake City, Utah, Forenede Stater, 84124
        • Wasatch Endoscopy Center
      • Salt Lake City, Utah, Forenede Stater, 84084
        • RGL Medical Services
  • Frankrig
      • Amiens Cedex 01, Frankrig, 80054
        • CHU Hopital Nord
      • Clichy, Frankrig, 92110
        • Hôpital Beaujon
      • Nantes CEDEX 1, Frankrig, 44093
        • CHU Hotel-Dieu
  • Holland
      • Amsterdam, Holland, 1081 HV
        • VU Medisch Centrum
      • Amsterdam, Holland, 1105 AZ
        • Academic Medical Center - University of Amsterdam, Dept. of Gastroenterology
      • Maastricht, Holland, 6229 HX
        • Academisch Ziekenhuis Maastricht
  • Polen
      • Warszawa, Polen, 02-507
        • Centralny Szpital Kliniczny MSWiA, Klinika Chorob Wewnetrznych i Gastroenterologii
  • Rumænien
      • Bucuresti, Rumænien, 010816
        • Sectia Clinica Medicina Interna II
  • Spanien
      • Barcelona, Spanien, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Madrid, Spanien, 28007
        • Hospital General Universitario Gregorio Marañón
  • Tyskland
      • Berlin, Tyskland, 10117
        • Charite - Campus Berlin Mitte
      • Heidelberg, Tyskland, 69120
        • Universitaetsklinikum Heidelberg
      • Kiel, Tyskland, 24105
        • Universitaetsklinikum Schleswig-Holstein, Campus Kiel
      • Minden, Tyskland, 32423
        • Gastroenterologische Gemeinschaftspraxis Minden
  • Ungarn
      • Budapest, Ungarn, 1136
        • Pannonia Maganorvosi Centrum Kft.
      • Budapest, Ungarn, 1125
        • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszati-Gasztroenterologiai Osztaly
      • Szekszard, Ungarn, 7100
        • Clinfan Kft.
  • Østrig
      • Linz, Østrig, 4020
        • Krankenhaus der Elisabethinen Linz GmbH
      • St. Poelten, Østrig, 3100
        • Landesklinikum St. Poelten
      • Wien, Østrig, 1090
        • AKH Wien Universitaetsklinik fuer Innere Medizin III

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

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male or Female, Age >=18 and <=65 years
  • Active ulcerative colitis (UC) beyond the rectum based upon Mayo Score
  • women of childbearing potential with highly effective method of contraception

Exclusion Criteria:

  • Indeterminate disease status, Crohn's disease, ischemic colitis, positive HIV, positive or history of tuberculosis infection, active enteric infections, transplant organ recipient, concomitant steroids, immunosuppressives or anti-TNFs.

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm 1
200 mg PF-05230917, Anrukinzumab active dose level
Biologisk: Anrukinzumab
200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
Andre navne:
  • PF-05230917
Biologisk: Anrukinzumab
200 mg sterile liquid vial, dose level 400 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
Andre navne:
  • PF-05230917
Biologisk: Anrukinzumab
200 mg sterile liquid vial, dose level 600 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12 Note: dosing in the 600 mg arm will be delayed until the safety of the 200 mg and 400 mg arms has been reviewed.
Andre navne:
  • PF-05230917
Eksperimentel: Arm 2
400 mg PF-05230917, Anrukinzumab active dose level
Biologisk: Anrukinzumab
200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
Andre navne:
  • PF-05230917
Biologisk: Anrukinzumab
200 mg sterile liquid vial, dose level 400 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
Andre navne:
  • PF-05230917
Biologisk: Anrukinzumab
200 mg sterile liquid vial, dose level 600 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12 Note: dosing in the 600 mg arm will be delayed until the safety of the 200 mg and 400 mg arms has been reviewed.
Andre navne:
  • PF-05230917
Eksperimentel: Arm 3
600 mg PF-05230917, Anrukinzumab active dose level
Biologisk: Anrukinzumab
200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
Andre navne:
  • PF-05230917
Biologisk: Anrukinzumab
200 mg sterile liquid vial, dose level 400 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
Andre navne:
  • PF-05230917
Biologisk: Anrukinzumab
200 mg sterile liquid vial, dose level 600 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12 Note: dosing in the 600 mg arm will be delayed until the safety of the 200 mg and 400 mg arms has been reviewed.
Andre navne:
  • PF-05230917
Placebo komparator: Arm 4
Matching placebo - administered at matching dose level 200 mg, 400 mg or 600 mg.
Andet: placebo
200 mg liquid sterile vial, administered at matching dose level 200 mg, 400 mg or 600 mg intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fold Change From Baseline in Fecal Calprotectin at Week 14
Tidsramme: Baseline, Week 14
The fold change from baseline in fecal calprotectin at Week 14, is the ratio of the measurement of fecal calprotectin at Week 14 to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at Week 14.
Baseline, Week 14

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum Observed Plasma Concentration (Cmax) for Anrukinzumab
Tidsramme: Pre-dose to end of the dosing interval after Day 1, Week 12
Maximum concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).
Pre-dose to end of the dosing interval after Day 1, Week 12
Minimum Observed Plasma Trough Concentration (Cmin) for Anrukinzumab
Tidsramme: Pre-dose to end of the dosing interval after Day 1, Week 12
Lowest concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).
Pre-dose to end of the dosing interval after Day 1, Week 12
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Anrukinzumab
Tidsramme: Pre-dose, within 1 hour post-end of infusion on Day 1; Day 2, 4, 7, pre-dose on Week 2
Area under the plasma concentration curve from time zero to end of dosing interval (2 weeks) was reported.
Pre-dose, within 1 hour post-end of infusion on Day 1; Day 2, 4, 7, pre-dose on Week 2
Plasma Decay Half-Life (t1/2) for Anrukinzumab
Tidsramme: Within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
Systemic Clearance (CL) for Anrukinzumab
Tidsramme: Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
Volume of Distribution (Vz) for Anrukinzumab
Tidsramme: Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
Fold Change From Baseline in Fecal Calprotectin at Week 2, 4, 8 and 12
Tidsramme: Baseline, Week 2, 4, 8, 12
The fold change from baseline in fecal calprotectin at post-baseline visit, is the ratio of the measurement of fecal calprotectin at post-baseline visit to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at post-baseline visit.
Baseline, Week 2, 4, 8, 12
Total Interleukin-13 (IL-13) Level
Tidsramme: Baseline, Day 2, 4, 7, Week 2, 4, 8, 12, 14, 16, 20, 24, 28, 32
Baseline, Day 2, 4, 7, Week 2, 4, 8, 12, 14, 16, 20, 24, 28, 32
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Baseline up to Week 32
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 32 that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study drug, which occurred during the trial.
Baseline up to Week 32
Number of Participants Who Discontinued From the Study Due to Adverse Events
Tidsramme: Baseline up to Week 32
Baseline up to Week 32
Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody
Tidsramme: Day 1, Week 4, 8, 12, 14, 16, 20, 24, 28, 32
Neutralizing antibody was not analyzed as no participant had positive ADA samples.
Day 1, Week 4, 8, 12, 14, 16, 20, 24, 28, 32
Number of Participants With Change From Baseline in Endoscopic Subscore at Week 14
Tidsramme: Baseline, Week 14
Mayo score is used to measure the disease activity of ulcerative colitis. Endoscopy or flexible sigmoidoscopy is a sub score of Mayo score. The score for endoscopic subscore ranges from 0 to 3, where higher score indicates more severe disease activity. Participant's score for endoscopy or flexible sigmoidoscopy at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.
Baseline, Week 14

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical Response Rate at Week 14
Tidsramme: Week 14
Clinical response rate is defined as percentage of participants with at least 3 point decrease from baseline in total Mayo score with at least 30% change along with 1 point decrease from baseline or absolute score of 0 or 1 in rectal bleeding. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy [endoscopy] and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.
Week 14
Clinical Remission Rate at Week 14
Tidsramme: Week 14
Clinical remission rate is defined as percentage of participants with a total Mayo score less than or equal to 2, with no individual subscore greater than 1 at post baseline visit. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.
Week 14
Change From Baseline in Total Mayo Score at Week 14
Tidsramme: Baseline, Week 14
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy [endoscopy] and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.
Baseline, Week 14
Number of Participants With Change From Baseline in Stool Frequency at Week 14
Tidsramme: Baseline, Week 14
Stool frequency is a sub score of Mayo score used to measure the disease activity of ulcerative colitis. The score for stool frequency ranges from 0 to 3, where higher score indicates more severe disease activity. Participant's score for stool frequency at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.
Baseline, Week 14
Number of Participants With Change From Baseline in Rectal Bleeding at Week 14
Tidsramme: Baseline, Week 14
Mayo score is used to measure the disease activity of ulcerative colitis. Rectal bleeding is a sub score of Mayo score. The score for rectal bleeding ranges from 0 to 3, where higher score indicates more severe disease activity. Participant's score for rectal bleeding at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.
Baseline, Week 14

Samarbejdspartnere og efterforskere

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

Sponsor

Pfizer

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.

Generelle publikationer

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

1. marts 2011

Primær færdiggørelse (Faktiske)

1. april 2013

Studieafslutning (Faktiske)

1. april 2013

Datoer for studieregistrering

Først indsendt

25. januar 2011

Først indsendt, der opfyldte QC-kriterier

25. januar 2011

Først opslået (Skøn)

26. januar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. november 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. november 2014

Sidst verificeret

1. november 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B2421003
  • IMA-638 Anti-IL13 mAb
  • 2010-023762-49 (EudraCT nummer)

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

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Togo

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner