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A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis

Primary Purpose

Moderate to Severe Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
50 mg Induction/Chronic
450 mg Induction/Chronic
150 mg Induction/Chronic
0 mg Induction ONLY
Sponsored by
Telavant, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Ulcerative Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:-

  • A diagnosis of UC for ≥3 months.

  • Participants with moderate to severe active UC as defined by a Total Mayo Score of

    ≥6, and an endoscopic subscore of ≥2.

  • Active disease beyond the rectum (>15 cm of active disease from the anal verge at the screening endoscopy).
  • Must have failed or been intolerant to at least one of the following class of medications: steroids, immunosuppressants, anti-TNFs, anti-integrin inhibitors, anti- IL-12/23 inhibitors, or JAK inhibitors.

Exclusion Criteria:

  • Participants with a diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohn's disease (eg, skip lesions, fistulae/perianal disease, non-necrotizing granulomas, etc.).
  • Participants with an imminent need for surgery or with elective surgery scheduled to occur during the study
  • Chest Radiograph showing abnormalities: The study will accept a Chest x-ray or computed tomography scan of the chest examination performed up to 12 weeks prior to screening if available.
  • 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
  • Infected with tuberculosis, (TB): Any evidence of untreated latent or active TB infection.
  • Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses

Sites / Locations

  • Digestive Health Specialists
  • Dothan Surgery Center
  • Flowers Hospital
  • Lynn Institute of the Ozarks
  • Surinder Saini, M.D., Inc.
  • Endoscopy Center of Connecticut, LLC
  • Endoscopy Center of Connecticut, LLC
  • Medical Research Center Of Connecticut, LLC
  • PACT Gastroenterology Center
  • Whitney Imaging
  • Medycal Research Inc.
  • Safety Harbor Surgery
  • Trident Care
  • Tower Radiology Center
  • Akumin
  • Tampa Bay Endoscopy Center
  • Alliance Clinical Research of Tampa
  • Gastroenterology Consultants P.C.
  • The University of Chicago Medical Center (clinic address)
  • The University of Chicago Medical Center
  • University of Iowa Hospitals and Clinics
  • Brigham & Women's Hospital
  • Brigham and Women's Hospital - Office
  • Brigham and Women's Hospital
  • Michigan Endoscopy Center
  • Valley View Surgery Center
  • Sierra Clinical Research
  • Weill Cornell Medical College - New York Presbyterian Hospital
  • Weill Cornell Medical College
  • New York Presbyterian Hospital - Weill Cornell Medical Center
  • Weill Cornell Medical College - New York Presbyterian Hospital
  • Weill Cornell Medical College- New York Presbyterian Hospital
  • Investigational Drug Services
  • Perelman Center for Advanced Medicine
  • Gastroenterology Associates, PA of Greenville
  • Vanderbilt GI Endoscopy Lab at One Hundred Oaks
  • Vanderbilt Heart One Hundred Oaks
  • Vanderbilt Inflammatory Bowel Disease Clinic
  • Vanderbilt Laboratory Services North One Hundred Oaks
  • Vanderbilt One Hundred Oaks Imaging
  • Vanderbilt University Medical Center - GI Research Office
  • Vanderbilt University Medical Center
  • Vanderbilt University Med. Center
  • Vanderbilt University Medical Center- Heart Station (ECG)
  • Vanderbilt University Medical Center
  • PrimeCare Medical Group
  • Gastroenterology Consultants of San Antonio, PA
  • VIP Trials
  • South Texas Radiology Imaging Centers
  • Gastroenterology Associates of Northern VA
  • Gastroenterology Associates of Northern Virginia
  • Verity Research, Inc.
  • Medical Diagnostic Imaging
  • Allegiance Internal Medicine and Allegiance Research Specialists
  • GI Associates
  • Concord Repatriation General Hospital
  • Mater Misericordiae Ltd.
  • Royal Adelaide Hospital
  • University Hospitals Leuven/Department of Gastroenterology
  • "ACIBADEM City Clinic Diagnostic-Consultative Center" EOOD
  • Asociacion IPS Medicos Internistas de Caldas
  • CHU d'Amiens-Picardie - SITE SUD
  • Centre Hospitalier Regional Universitaire (CHU) de Lille - CIC
  • Centre Hospitalier Regional Universitaire (CHU) de Lille - Hopital Claude Huriez
  • Centre Hospitalier Regional Universitaire (CHU) de Lille
  • CHU Hôtel-Dieu
  • Centre Hospitalier Lyon Sud
  • Centre Hospitalier Universitaire de Lyon Sud
  • Deutsches Rotes Kreuz Schwesternschaft Berlin Gemeinnützige Krankenhaus GmbH
  • Studiengesellschaft BSF Unternehmergesellschaft
  • Studiengesellschaft BSF UG (haftungsbeschränkt)
  • DRC Gyogyszervizsgalo Kozpont Kft.
  • Magyar Imre Kórház
  • Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.
  • Clinfan Kft.
  • Life Egészségcentrum
  • Deák Jenő Kórház
  • Clinexpert Tatabanya, Szent Borbala Hospital
  • Szofia Private Clinic
  • Shree Giriraj Multispeciality Hospital
  • Surat Institute of Digestive Sciences
  • Gujarat Hospital Gastro and Vascular Centre, Opp. Shree Ram Petrol Pump
  • M.S. Ramaiah Medical College and Hospitals,
  • M.S. Ramaiah Medical College and Hospitals
  • Grant Medical Foundation, Ruby Hall Clinic
  • S.R. Kalla Memorial Gastro & General Hospital
  • S.M.S. Medical College & Hospital
  • IRCCS "Saverio de Bellis", UOC Gastroenterologia
  • Istituto Clinico Humanitas Centro per le Malattie Infiammatorie Croniche dell'Intestino - IBD Cent
  • A.O.U. dell'Università degli Studi della Campania "Luigi Vanvitelli"
  • Policlinico Universitario Campus Bio-Medico di Roma
  • UO Malattie retto-Intestinali Ospedale "Sacro Cuore-don Calabria"
  • Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
  • Aichi Medical University Hospital
  • Toho University Sakura Medical Center
  • Kurume University Hospital
  • Sapporo Medical University Hospital
  • National Hospital Organization Sendai Medical Center
  • Tokyo Medical And Dental University Hospital
  • Keio University Hospital
  • Fukuoka University Hospital
  • BRCR Global Mexico
  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion
  • Karla Adriana Espinosa Bautista
  • Smiq S. de R.L. de C.V.
  • KLIMED Marek Klimkiewicz
  • Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
  • MZ Badania Slowik Zymla Sp. j.
  • ENDOSKOPIA Sp. z o. o.
  • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • WIP Warsaw IBD Point Profesor Kierkus
  • NZOZ Vivamed Jadwiga Miecz
  • Centrum Medyczne Melita Medical
  • Medlife S.A.
  • Spitalul Clinic Colentina
  • Pyatigorsk City Clinical Hospital
  • KDC "Evromedservis", OJSC
  • Limited Liability Company "Medicinsky Center SibNovoMed"
  • LLC Novosibirskiy Gastrocenter
  • Clinic of OSMU
  • Perm Clinical Centre of the Federal Medical-Biological Agency
  • Private Healthcare Institution "Clinical Hospital" Russian Railways-Medicine "Samara city"
  • Clinical Hospital named after S.R. Mirotvortsev
  • Research Institute of Antimicrobial Chemotherapy
  • Tomsk Regional Clinical Hospital
  • City Hospital JSC "Medical centre"
  • SBHI YaR "Regional Clinical Hospital"
  • Klinicki Centar Kragujevac
  • Opsta Bolnica Subotica
  • Opsta Bolnica "Djordje Joanovic", Odeljenje Interno, Odsek Gastroenterologija
  • KM Management spol. s.r.o.
  • Gastro LM s.r.o
  • ENDOMED, s.r.o.
  • Dr van Dyk & Partners Inc
  • IATROS International
  • Universitas Private Hospital
  • Ahmed Kathrada Private Hospital
  • Lenasia Clinical Trial Centre
  • Arwyp Medical Centre
  • Clinresco Centres (Pty) Ltd
  • Emmed Research
  • Radiology24 Jakaranda Hospital
  • Mediclinic Kloof Hospital
  • Hospital Universitario de Fuenlabrada
  • King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University
  • Songklanagarind Hospital, Prince of Songkla University
  • Phramongkutklao Hospital
  • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
  • Istanbul Universitesi Istanbul Tip Fakultesi
  • Kocaeli Universitesi Tip Fakultesi, Ic Hastaliklari Anabilim Dali
  • Mersin Universitesi Tip Fakultesi Hastanesi
  • Bulent Ecevit Universitesi Tip Fakultesi
  • Municipal non-profit enterprise of Kharkiv regional council "Regional clinical hospital"
  • Municipal non-profit enterprise "City clinical hospital #2 named after O.O.Shalimov"
  • Medical Centre Medical Clinic Blagomed LLC
  • Municipal Non-profit Enterprise "Kyiv City Clinical Hospital #1"
  • Municipal Non-profit enterprise of Kyiv Regional Council "Kyiv regional hospital"
  • Municipal non-profit enterprise of Kyiv regional council "Kyiv regional clinical hospital"
  • Medical center of Limited Liability Company "Health Clinic", medical clinical research center
  • Medical Centre "DIACENTER" LLC
  • Endoscopy Facility - Spire Little Aston Hospital
  • MeDiNova North London Quality Research Site
  • MeDiNova Northamptonshire Quality Research Site
  • Egin Research Ltd
  • Chest X-ray Facility - BMI Bishops Wood Hospital
  • Spire Nottingham Hospital
  • Endoscopy Facility - Orpington Endoscopy Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1 Induction

Cohort 2 Induction

Cohort 3 Induction

Cohort 4 Induction

Cohort 5 Chronic

Cohort 6 Chronic

Cohort 7 Chronic

Cohort 8 Chronic

Cohort 9 Chronic

Cohort 10 Chronic

Cohort 11 Chronic

Cohort 12 Chronic

Cohort 13 Chronic

Arm Description

450 mg PF-06480605

150 mg PF-06480605

50 mg PF-06480605

0 mg

450 mg to 450 mg PF-06480605

450 mg to 150 mg PF-06480605

450 mg to 50 mg PF-06480605

150 mg to 150 mg PF-06480605

150 mg to 50 mg PF-06480605

50 mg to 50 mg PF-06480605

0 mg to 450 mg PF-06480605

0 mg to 150 mg PF-06480605

0 mg to 50mg PF-06480605

Outcomes

Primary Outcome Measures

Proportion of participants achieving clinical remission (defined as a Total Mayo Score ≤2, with no individual subscore >1) at Week 14. Safety and tolerability will also be assessed
Incidence and severity of treatment emergent adverse events (TEAEs) during the induction period.
Incidence of serious adverse events (SAEs) during the induction period.
Incidence of AEs or SAEs leading to discontinuation during the induction period.
Incidence of clinically significant abnormalities in vital signs, electrocaridograms, (ECGs) and laboratory values during the induction period.
Incidence and severity of treatment emergent adverse events (TEAEs) during the chronic therapy period.
Incidence of serious adverse events (SAEs) during the chronic therapy period.
Incidence of AEs or SAEs leading to discontinuation during the chronic therapy period.
Incidence of clinically significant abnormalities in vital signs, ECGs and laboratory values during the chronic therapy period.

Secondary Outcome Measures

Proportion of participants achieving remission Food and Drug Administration, ((FDA) definition 1 - defined as endoscopic subscore = 0 or 1, stool frequency subscore = 0, and rectal bleeding subscore = 0) at Week 14.
Proportion of participants achieving remission (FDA definition 2 - defined as endoscopic subscore = 0 or 1, ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 or 1, and rectal bleeding subscore = 0) at Week 14.
Proportion of participants achieving endoscopic improvement (defined as endoscopic subscore = 0 or 1) at Week 14.
Proportion of participants achieving endoscopic remission (defined as endoscopic subscore = 0) at Week 14.
PF 06480605 trough concentrations during the induction period through Week 14.
Change from baseline in fecal calprotectin during the induction period through Week 14.
Change from baseline in hsCRP during the induction period through Week 14.
Change from baseline in serum sTL1A during the induction period through Week 14.
Incidence of development of anti drug antibodies (ADAs) and neutralizing antibodies (NAbs) during the induction period through Week 14.
Proportion of participants achieving clinical remission (defined as a Total Mayo Score >/= to 2, with no individual subscore >1) at Week 56.
Proportion of participants achieving sustained clinical remission (ie, clinical remission at both Week 14 and Week 56).
Proportion of participants achieving remission (FDA definition 1 - defined as endoscopic subscore = 0 or 1, stool frequency subscore = 0, and rectal bleeding subscore = 0) at Week 56.
Proportion of participants achieving sustained remission-FDA definition 1 (ie, remission-FDA definition 1 at both Week 14 and Week 56).
Proportion of participants achieving sustained remission-FDA definition 2 (ie, remission-FDA definition 2 at both Week 14 and Week 56).
Proportion of participants achieving endoscopic improvement (defined as endoscopic subscore = 0 or 1) at Week 56.
Proportion of participants achieving sustained endoscopic improvement (ie, endoscopic improvement at both Week 14 and Week 56).
Proportion of participants achieving endoscopic remission (defined as endoscopic sub-score = 0) at Week 56.
Proportion of participants achieving sustained endoscopic remission (ie, endoscopic remission at both Week 14 and Week 56).
PF-06480605 concentration from Week 14 through the End of Study Visit.
Change from Week 14 in fecal calprotectin during the chronic therapy period through the End of Study Visit
Change from Week 14 in hsCRP during the chronic therapy period through the End of Study Visit.
Change from week 14 in serum sTL1A during the chronic therapy period through the End of Study Visit.
Change from baseline through the End of the Study Visit in fecal calprotectin
Change from baseline through the End of the Study Visit in hsCRP.
Change from baseline through the End of Study Visit in serum sTL1A.
Incidence of development of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) from Week 14 through the End of Study Visit.

Full Information

First Posted
September 12, 2019
Last Updated
October 17, 2023
Sponsor
Telavant, Inc.
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04090411
Brief Title
A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis
Official Title
A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 19, 2019 (Actual)
Primary Completion Date
October 25, 2022 (Actual)
Study Completion Date
October 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Telavant, Inc.
Collaborators
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 Induction
Arm Type
Experimental
Arm Description
450 mg PF-06480605
Arm Title
Cohort 2 Induction
Arm Type
Experimental
Arm Description
150 mg PF-06480605
Arm Title
Cohort 3 Induction
Arm Type
Experimental
Arm Description
50 mg PF-06480605
Arm Title
Cohort 4 Induction
Arm Type
Placebo Comparator
Arm Description
0 mg
Arm Title
Cohort 5 Chronic
Arm Type
Experimental
Arm Description
450 mg to 450 mg PF-06480605
Arm Title
Cohort 6 Chronic
Arm Type
Experimental
Arm Description
450 mg to 150 mg PF-06480605
Arm Title
Cohort 7 Chronic
Arm Type
Experimental
Arm Description
450 mg to 50 mg PF-06480605
Arm Title
Cohort 8 Chronic
Arm Type
Experimental
Arm Description
150 mg to 150 mg PF-06480605
Arm Title
Cohort 9 Chronic
Arm Type
Experimental
Arm Description
150 mg to 50 mg PF-06480605
Arm Title
Cohort 10 Chronic
Arm Type
Experimental
Arm Description
50 mg to 50 mg PF-06480605
Arm Title
Cohort 11 Chronic
Arm Type
Experimental
Arm Description
0 mg to 450 mg PF-06480605
Arm Title
Cohort 12 Chronic
Arm Type
Experimental
Arm Description
0 mg to 150 mg PF-06480605
Arm Title
Cohort 13 Chronic
Arm Type
Experimental
Arm Description
0 mg to 50mg PF-06480605
Intervention Type
Drug
Intervention Name(s)
50 mg Induction/Chronic
Intervention Description
PF-06480605
Intervention Type
Drug
Intervention Name(s)
450 mg Induction/Chronic
Intervention Description
PF-06480605
Intervention Type
Drug
Intervention Name(s)
150 mg Induction/Chronic
Intervention Description
PF-06480605
Intervention Type
Other
Intervention Name(s)
0 mg Induction ONLY
Intervention Description
0 mg Placebo
Primary Outcome Measure Information:
Title
Proportion of participants achieving clinical remission (defined as a Total Mayo Score ≤2, with no individual subscore >1) at Week 14. Safety and tolerability will also be assessed
Time Frame
week 0-14
Title
Incidence and severity of treatment emergent adverse events (TEAEs) during the induction period.
Time Frame
week 0-14
Title
Incidence of serious adverse events (SAEs) during the induction period.
Time Frame
week 0-14
Title
Incidence of AEs or SAEs leading to discontinuation during the induction period.
Time Frame
week 0-14
Title
Incidence of clinically significant abnormalities in vital signs, electrocaridograms, (ECGs) and laboratory values during the induction period.
Time Frame
week 0-14
Title
Incidence and severity of treatment emergent adverse events (TEAEs) during the chronic therapy period.
Time Frame
Weeks 14-64
Title
Incidence of serious adverse events (SAEs) during the chronic therapy period.
Time Frame
Weeks 14-64
Title
Incidence of AEs or SAEs leading to discontinuation during the chronic therapy period.
Time Frame
Weeks 14-64
Title
Incidence of clinically significant abnormalities in vital signs, ECGs and laboratory values during the chronic therapy period.
Time Frame
Weeks 14-64
Secondary Outcome Measure Information:
Title
Proportion of participants achieving remission Food and Drug Administration, ((FDA) definition 1 - defined as endoscopic subscore = 0 or 1, stool frequency subscore = 0, and rectal bleeding subscore = 0) at Week 14.
Time Frame
week 0-14
Title
Proportion of participants achieving remission (FDA definition 2 - defined as endoscopic subscore = 0 or 1, ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 or 1, and rectal bleeding subscore = 0) at Week 14.
Time Frame
week 0-14
Title
Proportion of participants achieving endoscopic improvement (defined as endoscopic subscore = 0 or 1) at Week 14.
Time Frame
week 0-14
Title
Proportion of participants achieving endoscopic remission (defined as endoscopic subscore = 0) at Week 14.
Time Frame
week 0-14
Title
PF 06480605 trough concentrations during the induction period through Week 14.
Time Frame
week 0-14
Title
Change from baseline in fecal calprotectin during the induction period through Week 14.
Time Frame
week 0-14
Title
Change from baseline in hsCRP during the induction period through Week 14.
Time Frame
week 0-14
Title
Change from baseline in serum sTL1A during the induction period through Week 14.
Time Frame
week 0-14
Title
Incidence of development of anti drug antibodies (ADAs) and neutralizing antibodies (NAbs) during the induction period through Week 14.
Time Frame
week 0-14
Title
Proportion of participants achieving clinical remission (defined as a Total Mayo Score >/= to 2, with no individual subscore >1) at Week 56.
Time Frame
Weeks 14-56
Title
Proportion of participants achieving sustained clinical remission (ie, clinical remission at both Week 14 and Week 56).
Time Frame
Weeks 14-56
Title
Proportion of participants achieving remission (FDA definition 1 - defined as endoscopic subscore = 0 or 1, stool frequency subscore = 0, and rectal bleeding subscore = 0) at Week 56.
Time Frame
Weeks 14-56
Title
Proportion of participants achieving sustained remission-FDA definition 1 (ie, remission-FDA definition 1 at both Week 14 and Week 56).
Time Frame
Weeks 14-56
Title
Proportion of participants achieving sustained remission-FDA definition 2 (ie, remission-FDA definition 2 at both Week 14 and Week 56).
Time Frame
Weeks 14-56
Title
Proportion of participants achieving endoscopic improvement (defined as endoscopic subscore = 0 or 1) at Week 56.
Time Frame
Weeks 14-56
Title
Proportion of participants achieving sustained endoscopic improvement (ie, endoscopic improvement at both Week 14 and Week 56).
Time Frame
Weeks 14-56
Title
Proportion of participants achieving endoscopic remission (defined as endoscopic sub-score = 0) at Week 56.
Time Frame
Weeks 14-56
Title
Proportion of participants achieving sustained endoscopic remission (ie, endoscopic remission at both Week 14 and Week 56).
Time Frame
Weeks 14-56
Title
PF-06480605 concentration from Week 14 through the End of Study Visit.
Time Frame
Weeks 14-64
Title
Change from Week 14 in fecal calprotectin during the chronic therapy period through the End of Study Visit
Time Frame
Weeks 14-64
Title
Change from Week 14 in hsCRP during the chronic therapy period through the End of Study Visit.
Time Frame
Weeks 14-64
Title
Change from week 14 in serum sTL1A during the chronic therapy period through the End of Study Visit.
Time Frame
Weeks 14-64
Title
Change from baseline through the End of the Study Visit in fecal calprotectin
Time Frame
weeks 14-64
Title
Change from baseline through the End of the Study Visit in hsCRP.
Time Frame
Weeks 14-64
Title
Change from baseline through the End of Study Visit in serum sTL1A.
Time Frame
Weeks 14-64
Title
Incidence of development of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) from Week 14 through the End of Study Visit.
Time Frame
Weeks 14-64

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:- A diagnosis of UC for ≥3 months. Participants with moderate to severe active UC as defined by a Total Mayo Score of ≥6, and an endoscopic subscore of ≥2. Active disease beyond the rectum (>15 cm of active disease from the anal verge at the screening endoscopy). Must have failed or been intolerant to at least one of the following class of medications: steroids, immunosuppressants, anti-TNFs, anti-integrin inhibitors, anti- IL-12/23 inhibitors, or JAK inhibitors. Exclusion Criteria: Participants with a diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohn's disease (eg, skip lesions, fistulae/perianal disease, non-necrotizing granulomas, etc.). Participants with an imminent need for surgery or with elective surgery scheduled to occur during the study Chest Radiograph showing abnormalities: The study will accept a Chest x-ray or computed tomography scan of the chest examination performed up to 12 weeks prior to screening if available. 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results Infected with tuberculosis, (TB): Any evidence of untreated latent or active TB infection. Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Digestive Health Specialists
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Facility Name
Dothan Surgery Center
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Facility Name
Flowers Hospital
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Lynn Institute of the Ozarks
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
Surinder Saini, M.D., Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Endoscopy Center of Connecticut, LLC
City
Guilford
State/Province
Connecticut
ZIP/Postal Code
06437
Country
United States
Facility Name
Endoscopy Center of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Medical Research Center Of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
PACT Gastroenterology Center
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Whitney Imaging
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Medycal Research Inc.
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Safety Harbor Surgery
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Trident Care
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33762
Country
United States
Facility Name
Tower Radiology Center
City
Oldsmar
State/Province
Florida
ZIP/Postal Code
34677
Country
United States
Facility Name
Akumin
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Tampa Bay Endoscopy Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Alliance Clinical Research of Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Gastroenterology Consultants P.C.
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
The University of Chicago Medical Center (clinic address)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Brigham and Women's Hospital - Office
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Michigan Endoscopy Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Valley View Surgery Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Sierra Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Weill Cornell Medical College - New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York Presbyterian Hospital - Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical College - New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical College- New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Investigational Drug Services
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Gastroenterology Associates, PA of Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Vanderbilt GI Endoscopy Lab at One Hundred Oaks
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Vanderbilt Heart One Hundred Oaks
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Vanderbilt Inflammatory Bowel Disease Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Vanderbilt Laboratory Services North One Hundred Oaks
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Vanderbilt One Hundred Oaks Imaging
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Vanderbilt University Medical Center - GI Research Office
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-1610
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Vanderbilt University Med. Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-5543
Country
United States
Facility Name
Vanderbilt University Medical Center- Heart Station (ECG)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
PrimeCare Medical Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Gastroenterology Consultants of San Antonio, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
VIP Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
South Texas Radiology Imaging Centers
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Gastroenterology Associates of Northern VA
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Gastroenterology Associates of Northern Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Verity Research, Inc.
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Medical Diagnostic Imaging
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53222
Country
United States
Facility Name
Allegiance Internal Medicine and Allegiance Research Specialists
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
GI Associates
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Mater Misericordiae Ltd.
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
University Hospitals Leuven/Department of Gastroenterology
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
"ACIBADEM City Clinic Diagnostic-Consultative Center" EOOD
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
Asociacion IPS Medicos Internistas de Caldas
City
Manizales
State/Province
Caldas
ZIP/Postal Code
170004
Country
Colombia
Facility Name
CHU d'Amiens-Picardie - SITE SUD
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
Centre Hospitalier Regional Universitaire (CHU) de Lille - CIC
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospitalier Regional Universitaire (CHU) de Lille - Hopital Claude Huriez
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospitalier Regional Universitaire (CHU) de Lille
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Hôtel-Dieu
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Benite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Hospitalier Universitaire de Lyon Sud
City
Pierre-Bénite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Deutsches Rotes Kreuz Schwesternschaft Berlin Gemeinnützige Krankenhaus GmbH
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Studiengesellschaft BSF Unternehmergesellschaft
City
Halle (Saale)
ZIP/Postal Code
06108
Country
Germany
Facility Name
Studiengesellschaft BSF UG (haftungsbeschränkt)
City
Halle/Saale
ZIP/Postal Code
06108
Country
Germany
Facility Name
DRC Gyogyszervizsgalo Kozpont Kft.
City
Balatonfured
State/Province
Veszprem
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Magyar Imre Kórház
City
Ajka
ZIP/Postal Code
8400
Country
Hungary
Facility Name
Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.
City
Budapest
ZIP/Postal Code
H-1033
Country
Hungary
Facility Name
Clinfan Kft.
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Life Egészségcentrum
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Deák Jenő Kórház
City
Tapolca
ZIP/Postal Code
8300
Country
Hungary
Facility Name
Clinexpert Tatabanya, Szent Borbala Hospital
City
Tatabanya
ZIP/Postal Code
H-2800
Country
Hungary
Facility Name
Szofia Private Clinic
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Shree Giriraj Multispeciality Hospital
City
Rajkot
State/Province
Gujarat
ZIP/Postal Code
360005
Country
India
Facility Name
Surat Institute of Digestive Sciences
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Facility Name
Gujarat Hospital Gastro and Vascular Centre, Opp. Shree Ram Petrol Pump
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395009
Country
India
Facility Name
M.S. Ramaiah Medical College and Hospitals,
City
Bangalore,
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
M.S. Ramaiah Medical College and Hospitals
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
Grant Medical Foundation, Ruby Hall Clinic
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
S.R. Kalla Memorial Gastro & General Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302001
Country
India
Facility Name
S.M.S. Medical College & Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302004
Country
India
Facility Name
IRCCS "Saverio de Bellis", UOC Gastroenterologia
City
Castellana Grotte
State/Province
Bari
ZIP/Postal Code
70013
Country
Italy
Facility Name
Istituto Clinico Humanitas Centro per le Malattie Infiammatorie Croniche dell'Intestino - IBD Cent
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy
Facility Name
A.O.U. dell'Università degli Studi della Campania "Luigi Vanvitelli"
City
Napoli
State/Province
Naples
ZIP/Postal Code
80138
Country
Italy
Facility Name
Policlinico Universitario Campus Bio-Medico di Roma
City
Roma
State/Province
RM
ZIP/Postal Code
00128
Country
Italy
Facility Name
UO Malattie retto-Intestinali Ospedale "Sacro Cuore-don Calabria"
City
Negrar
State/Province
Verona
ZIP/Postal Code
37024
Country
Italy
Facility Name
Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Aichi Medical University Hospital
City
Nagakute
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Toho University Sakura Medical Center
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
National Hospital Organization Sendai Medical Center
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
983-8520
Country
Japan
Facility Name
Tokyo Medical And Dental University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
BRCR Global Mexico
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97130
Country
Mexico
Facility Name
Karla Adriana Espinosa Bautista
City
Ciudad de Mexico
ZIP/Postal Code
01120
Country
Mexico
Facility Name
Smiq S. de R.L. de C.V.
City
Queretaro
ZIP/Postal Code
76070
Country
Mexico
Facility Name
KLIMED Marek Klimkiewicz
City
Bialystok
ZIP/Postal Code
15-704
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
City
Knurow
ZIP/Postal Code
44-190
Country
Poland
Facility Name
MZ Badania Slowik Zymla Sp. j.
City
Knurow
ZIP/Postal Code
44-190
Country
Poland
Facility Name
ENDOSKOPIA Sp. z o. o.
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Twoja Przychodnia - Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
WIP Warsaw IBD Point Profesor Kierkus
City
Warszawa
ZIP/Postal Code
00-728
Country
Poland
Facility Name
NZOZ Vivamed Jadwiga Miecz
City
Warszawa
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Centrum Medyczne Melita Medical
City
Wroclaw
ZIP/Postal Code
50-449
Country
Poland
Facility Name
Medlife S.A.
City
Bucuresti
ZIP/Postal Code
010719
Country
Romania
Facility Name
Spitalul Clinic Colentina
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
Facility Name
Pyatigorsk City Clinical Hospital
City
Pyatigorsk
State/Province
Stavropol Region
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
KDC "Evromedservis", OJSC
City
Moscow
ZIP/Postal Code
115419
Country
Russian Federation
Facility Name
Limited Liability Company "Medicinsky Center SibNovoMed"
City
Novosibirsk
ZIP/Postal Code
630005
Country
Russian Federation
Facility Name
LLC Novosibirskiy Gastrocenter
City
Novosibirsk
ZIP/Postal Code
630007
Country
Russian Federation
Facility Name
Clinic of OSMU
City
Omsk
ZIP/Postal Code
644050
Country
Russian Federation
Facility Name
Perm Clinical Centre of the Federal Medical-Biological Agency
City
Perm
ZIP/Postal Code
614109
Country
Russian Federation
Facility Name
Private Healthcare Institution "Clinical Hospital" Russian Railways-Medicine "Samara city"
City
Samara
ZIP/Postal Code
443029
Country
Russian Federation
Facility Name
Clinical Hospital named after S.R. Mirotvortsev
City
Saratov
ZIP/Postal Code
410054
Country
Russian Federation
Facility Name
Research Institute of Antimicrobial Chemotherapy
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Tomsk Regional Clinical Hospital
City
Tomsk
ZIP/Postal Code
634063
Country
Russian Federation
Facility Name
City Hospital JSC "Medical centre"
City
Tyumen
ZIP/Postal Code
625007
Country
Russian Federation
Facility Name
SBHI YaR "Regional Clinical Hospital"
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Klinicki Centar Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Opsta Bolnica Subotica
City
Subotica
ZIP/Postal Code
24000
Country
Serbia
Facility Name
Opsta Bolnica "Djordje Joanovic", Odeljenje Interno, Odsek Gastroenterologija
City
Zrenjanin
ZIP/Postal Code
23000
Country
Serbia
Facility Name
KM Management spol. s.r.o.
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Gastro LM s.r.o
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
ENDOMED, s.r.o.
City
Vranov nad Toplou
ZIP/Postal Code
093 01
Country
Slovakia
Facility Name
Dr van Dyk & Partners Inc
City
Bloemfontein
State/Province
FREE State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
IATROS International
City
Bloemfontein
State/Province
FREE State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Universitas Private Hospital
City
Bloemfontein
State/Province
FREE State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Ahmed Kathrada Private Hospital
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1827
Country
South Africa
Facility Name
Lenasia Clinical Trial Centre
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1827
Country
South Africa
Facility Name
Arwyp Medical Centre
City
Kempton Park
State/Province
Gauteng
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Clinresco Centres (Pty) Ltd
City
Kempton Park
State/Province
Gauteng
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Emmed Research
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Radiology24 Jakaranda Hospital
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Mediclinic Kloof Hospital
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0048
Country
South Africa
Facility Name
Hospital Universitario de Fuenlabrada
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University
City
Pathum Wan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Songklanagarind Hospital, Prince of Songkla University
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Phramongkutklao Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Istanbul Universitesi Istanbul Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Kocaeli Universitesi Tip Fakultesi, Ic Hastaliklari Anabilim Dali
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Mersin Universitesi Tip Fakultesi Hastanesi
City
Mersin
ZIP/Postal Code
33110
Country
Turkey
Facility Name
Bulent Ecevit Universitesi Tip Fakultesi
City
Zonguldak
ZIP/Postal Code
67600
Country
Turkey
Facility Name
Municipal non-profit enterprise of Kharkiv regional council "Regional clinical hospital"
City
Kharkiv
ZIP/Postal Code
61024
Country
Ukraine
Facility Name
Municipal non-profit enterprise "City clinical hospital #2 named after O.O.Shalimov"
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Medical Centre Medical Clinic Blagomed LLC
City
Kyiv
ZIP/Postal Code
01023
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise "Kyiv City Clinical Hospital #1"
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Municipal Non-profit enterprise of Kyiv Regional Council "Kyiv regional hospital"
City
Kyiv
ZIP/Postal Code
04078
Country
Ukraine
Facility Name
Municipal non-profit enterprise of Kyiv regional council "Kyiv regional clinical hospital"
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Medical center of Limited Liability Company "Health Clinic", medical clinical research center
City
Vinnytsia
ZIP/Postal Code
21009
Country
Ukraine
Facility Name
Medical Centre "DIACENTER" LLC
City
Zaporizhzhia
ZIP/Postal Code
69076
Country
Ukraine
Facility Name
Endoscopy Facility - Spire Little Aston Hospital
City
Sutton Coldfield
State/Province
Birmingham
ZIP/Postal Code
B74 3UP
Country
United Kingdom
Facility Name
MeDiNova North London Quality Research Site
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
MeDiNova Northamptonshire Quality Research Site
City
Corby
ZIP/Postal Code
NN18 9EZ
Country
United Kingdom
Facility Name
Egin Research Ltd
City
High Wycombe
ZIP/Postal Code
HP11 2QW
Country
United Kingdom
Facility Name
Chest X-ray Facility - BMI Bishops Wood Hospital
City
Northwood
ZIP/Postal Code
HA6 2JW
Country
United Kingdom
Facility Name
Spire Nottingham Hospital
City
Nottingham
ZIP/Postal Code
NG12 4GA
Country
United Kingdom
Facility Name
Endoscopy Facility - Orpington Endoscopy Centre
City
Orpington
ZIP/Postal Code
BR5 3TW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7541007
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis

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