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Colitis, UlcerativePhase 2NCT01284062

Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

A Phase 2 study testing Anrukinzumab in people with Colitis, Ulcerative, run by Pfizer at 76 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Colitis, Ulcerative
What is being tested?
Anrukinzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
76 sitesin 11 countries
Study dates
Mar 2011to Apr 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

76 sites in 11 countries.

76 sites in 11 countries

United States48 sites

  • AGMG Endoscopy Center

    Anaheim, California, 92801

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801

  • Professional Quality Research, Inc.

    Austin, Texas, 78705

  • Austin Endoscopy Center

    Austin, Texas, 78757

  • Austin Gastroenterology, PA

    Austin, Texas, 78757

  • The Kirkland Clinic

    Birmingham, Alabama, 35233

  • UAB Hospital

    Birmingham, Alabama, 35233

  • UAB Hospital Department of Pharmacy

    Birmingham, Alabama, 35249

  • Administrative Offices

    Birmingham, Alabama, 35294

  • UAB ACIP

    Birmingham, Alabama, 35294

  • University Hospitals Case Medical Center - Division of Gastroenterology and Liver Disease

    Cleveland, Ohio, 44106

  • Memphis Gastroenterology Group, PC

    Germantown, Tennessee, 38138

  • Endoscopy Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • Gastroenterology Center of Connecticut, PC

    Hamden, Connecticut, 06518

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • Texas Center for Drug Development, Inc.

    Houston, Texas, 77081

  • Gastrointestinal Associates, PA

    Jackson, Mississippi, 39202

  • Gastrointestional Associates, PA

    Jackson, Mississippi, 39202

  • St. Dominic Hospital

    Jackson, Mississippi, 39216

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060

  • GI Diagnostics

    Marietta, Georgia, 30067

  • The West Clinic

    Memphis, Tennessee, 38120

  • CNS Pharmacy

    Murray, Utah, 84123

  • Centennial Medical Center Physicians Park

    Nashville, Tennessee, 37203

  • Centennial Medical Center Tower Medical Imaging

    Nashville, Tennessee, 37203

  • Columbia Medical Group - The First Clinic Inc.

    Nashville, Tennessee, 37203

  • Radiology Alliance

    Nashville, Tennessee, 37203

  • Wheeler and Stuckey, Inc.

    Oklahoma City, Oklahoma, 73103

  • Oklahoma Foundation for Digestive Research

    Oklahoma City, Oklahoma, 73104

  • OU Physicians Building

    Oklahoma City, Oklahoma, 73104

  • Arizona Surgical Center

    Phoenix, Arizona, 85006

  • Dedicated Phase I, Inc.

    Phoenix, Arizona, 85013

  • Premier Medical Group of the Hudson Valley

    Poughkeepsie, New York, 12601

  • Austin Gastroenterology, PA

    Round Rocks, Texas, 78681

  • RGL Medical Services

    Salt Lake City, Utah, 84084

  • Alpine Medical Group

    Salt Lake City, Utah, 84102

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107

  • Wasatch Endoscopy Center

    Salt Lake City, Utah, 84124

  • University of Utah Hospital

    Salt Lake City, Utah, 84132

  • Cardiology Clinic of San Antonio

    San Antonio, Texas, 78229

  • Gastroenterology Research of San Antonio

    San Antonio, Texas, 78229

  • San Antonio Endoscopy Center

    San Antonio, Texas, 78229

  • International Clinical Research - US, LLC

    Sanford, Florida, 32771

  • West Coast Radiology Center

    Santa Ana, California, 92705

  • Digestive Health Specialists, PA

    Tupelo, Mississippi, 38801

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801

  • Piedmont Gastroenterology Specialists

    Winston-Salem, North Carolina, 27103

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada5 sites

  • Heritage Medical Research Clinic - University of Calgary

    Calgary, Alberta, T2N 4Z6

  • The Religious Hospitallers of St. Joseph of the Hotel Dieu of Kingston

    Kingston, Ontario, K7L 5G2

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Vancouver Coastal Health - Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • Vancouver General Hospital - The Gordon and Leslie Diamond Centre

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Germany4 sites

  • Charite - Campus Berlin Mitte

    Berlin, 10117

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Gastroenterologische Gemeinschaftspraxis Minden

    Minden, 32423

Other trials in Germany

Austria3 sites

  • Krankenhaus der Elisabethinen Linz GmbH

    Linz, 4020

  • Landesklinikum St. Poelten

    Sankt Pölten, 3100

  • AKH Wien Universitaetsklinik fuer Innere Medizin III

    Vienna, 1090

Other trials in Austria

Bulgaria3 sites

  • MBAL Ruse / MHAT Ruse, Terapevtichno, gastroenterologichno i hematologichno otdelenie

    Rousse, 7002

  • MBAL Voennomeditsinska Akademia / MMA HAT, Klinika po gastroenterologia i hepatologia

    Sofia, 1606

  • DKTs Sveta Anna, Gastroenterologichen cabinet

    Sofia, 1750

Other trials in Bulgaria

France3 sites

  • CHU Hopital Nord

    Amiens, 80054

  • Hopital Beaujon

    Clichy, 92110

  • CHU Hotel-Dieu

    Nantes, 44093

Other trials in France

Hungary3 sites

  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszati-Gasztroenterologiai Osztaly

    Budapest, 1125

  • Pannonia Maganorvosi Centrum Kft.

    Budapest, 1136

  • Clinfan Kft.

    Szekszárd, 7100

Other trials in Hungary

Netherlands3 sites

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • Academic Medical Center - University of Amsterdam, Dept. of Gastroenterology

    Amsterdam, 1105 AZ

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6229 HX

Other trials in Netherlands

Spain2 sites

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, Barcelona, 08036

  • Hospital General Universitario Gregorio Marañon

    Madrid, Madrid, 28007

Other trials in Spain

Poland1 site

  • Centralny Szpital Kliniczny MSWiA, Klinika Chorob Wewnetrznych i Gastroenterologii

    Warsaw, 02-507

Other trials in Poland

Romania1 site

  • Sectia Clinica Medicina Interna II

    Bucharest, 010816

Other trials in Romania

About this study

Official title: 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.

Being tested
Anrukinzumab, placebo
Keywords
Active Ulcerative Colitis, Phase 2A, Double-blind, Randomized, PK/PD Biomarker Study
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnrukinzumabBiological

    Also called PF-05230917

    200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12

  • AnrukinzumabBiological

    Also called PF-05230917

    200 mg sterile liquid vial, dose level 400 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12

  • AnrukinzumabBiological

    Also called PF-05230917

    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.

  • placeboOther

    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

Study groups in NCT01284062
Study groupRoleWhat they receive
Arm 1Experimental200 mg PF-05230917, Anrukinzumab active dose level
Receives: Biological: Anrukinzumab
Arm 2Experimental400 mg PF-05230917, Anrukinzumab active dose level
Receives: Biological: Anrukinzumab
Arm 3Experimental600 mg PF-05230917, Anrukinzumab active dose level
Receives: Biological: Anrukinzumab
Arm 4Placebo comparatorMatching placebo - administered at matching dose level 200 mg, 400 mg or 600 mg.
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fold Change From Baseline in Fecal Calprotectin at 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.

    Measured: Baseline, Week 14

Secondary outcomes (12)

  1. Maximum Observed Plasma Concentration (Cmax) for Anrukinzumab

    Maximum concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).

    Measured: Pre-dose to end of the dosing interval after Day 1, Week 12

  2. Minimum Observed Plasma Trough Concentration (Cmin) for Anrukinzumab

    Lowest concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).

    Measured: Pre-dose to end of the dosing interval after Day 1, Week 12

  3. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Anrukinzumab

    Area under the plasma concentration curve from time zero to end of dosing interval (2 weeks) was reported.

    Measured: Pre-dose, within 1 hour post-end of infusion on Day 1; Day 2, 4, 7, pre-dose on Week 2

  4. Plasma Decay Half-Life (t1/2) for Anrukinzumab

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

    Measured: Within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32

  5. Systemic Clearance (CL) for Anrukinzumab

    CL is a quantitative measure of the rate at which a drug substance is removed from the body.

    Measured: Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32

  6. Volume of Distribution (Vz) for Anrukinzumab

    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.

    Measured: Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32

  7. Fold Change From Baseline in Fecal Calprotectin at Week 2, 4, 8 and 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.

    Measured: Baseline, Week 2, 4, 8, 12

  8. Total Interleukin-13 (IL-13) Level

    Measured: Baseline, Day 2, 4, 7, Week 2, 4, 8, 12, 14, 16, 20, 24, 28, 32

  9. Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    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.

    Measured: Baseline up to Week 32

  10. Number of Participants Who Discontinued From the Study Due to Adverse Events

    Measured: Baseline up to Week 32

  11. Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody

    Neutralizing antibody was not analyzed as no participant had positive ADA samples.

    Measured: Day 1, Week 4, 8, 12, 14, 16, 20, 24, 28, 32

  12. Number of Participants With Change From Baseline in Endoscopic Subscore at 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.

    Measured: Baseline, Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01284062
Sponsor's protocol ID
B2421003
Other IDs
IMA-638 Anti-IL13 mAb, 2010-023762-49
Status last verified
Nov 2014
First submitted
25 Jan 2011
Last updated
18 Nov 2014
Data monitoring committee
No

Publications

  • Reinisch W, Panes J, Khurana S, Toth G, Hua F, Comer GM, Hinz M, Page K, O'Toole M, Moorehead TM, Zhu H, Sun Y, Cataldi F. Anrukinzumab, an anti-interleukin 13 monoclonal antibody, in active UC: efficacy and safety from a phase IIa randomised multicentre study. Gut. 2015 Jun;64(6):894-900. doi: 10.1136/gutjnl-2014-308337. Epub 2015 Jan 7.

    PubMed 25567115

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anrukinzumab in people with Colitis, Ulcerative, run by Pfizer at 76 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Canada, Germany, Austria, Bulgaria and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fold Change From Baseline in Fecal Calprotectin at Week 14 (time frame: Baseline, Week 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01284062, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2014.

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