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

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

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.

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Ulcerative Colitis
• Intervention / Treatment: Other: Induction- Placebo SC Q4W; Drug: Chronic- PF-06480605 50 mg SC Q4W; Drug: Chronic- PF-06480605 150 mg SC Q4W; Drug: Chronic- PF-06480605 450 mg SC Q4W; Drug: Induction- PF-06480605 50 mg SC Q4W; Drug: Induction- PF-06480605 150 mg SC Q4W; Drug: Induction- PF-06480605 450 mg SC Q4W

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 2; Induction - Placebo SC Q4W, Chronic- PF-06480605 150 mg SC Q4W	Other: Induction- Placebo SC Q4W; 0 mg Placebo; Drug: Chronic- PF-06480605 150 mg SC Q4W; PF-06480605
Experimental: Cohort 3; Induction - Placebo SC Q4W, Chronic- PF-06480605 450 mg SC Q4W	Other: Induction- Placebo SC Q4W; 0 mg Placebo; Drug: Chronic- PF-06480605 450 mg SC Q4W; PF-06480605
Placebo Comparator: Cohort 4; Induction- PF-06480605 50 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W	Drug: Chronic- PF-06480605 50 mg SC Q4W; PF-06480605; Drug: Induction- PF-06480605 50 mg SC Q4W; PF-06480605
Experimental: Cohort 5; Induction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W	Drug: Chronic- PF-06480605 50 mg SC Q4W; PF-06480605; Drug: Induction- PF-06480605 150 mg SC Q4W; PF-06480605
Experimental: Cohort 6; Induction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W	Drug: Chronic- PF-06480605 150 mg SC Q4W; PF-06480605; Drug: Induction- PF-06480605 150 mg SC Q4W; PF-06480605
Experimental: Cohort 7; Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W	Drug: Chronic- PF-06480605 50 mg SC Q4W; PF-06480605; Drug: Induction- PF-06480605 450 mg SC Q4W; PF-06480605
Experimental: Cohort 8; Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W	Drug: Chronic- PF-06480605 150 mg SC Q4W; PF-06480605; Drug: Induction- PF-06480605 450 mg SC Q4W; PF-06480605
Experimental: Cohort 9; Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 450 mg SC Q4W	Drug: Chronic- PF-06480605 450 mg SC Q4W; PF-06480605; Drug: Induction- PF-06480605 450 mg SC Q4W; PF-06480605
Experimental: Cohort 1; Induction - Placebo SC Q4W, (sub-cutaneous every 4 weeks) Chronic- PF-06480605 50 mg SC Q4W	Other: Induction- Placebo SC Q4W; 0 mg Placebo; Drug: Chronic- PF-06480605 50 mg SC Q4W; PF-06480605

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	week 0-14
Incidence and severity of treatment emergent adverse events (TEAEs) during the induction period.	week 0-14
Incidence of serious adverse events (SAEs) during the induction period.	week 0-14
Incidence of AEs or SAEs leading to discontinuation during the induction period.	week 0-14
Incidence of clinically significant abnormalities in vital signs, electrocaridograms, (ECGs) and laboratory values during the induction period.	week 0-14
Incidence and severity of treatment emergent adverse events (TEAEs) during the chronic therapy period.	Weeks 14-64
Incidence of serious adverse events (SAEs) during the chronic therapy period.	Weeks 14-64
Incidence of AEs or SAEs leading to discontinuation during the chronic therapy period.	Weeks 14-64
Incidence of clinically significant abnormalities in vital signs, ECGs and laboratory values during the chronic therapy period.	Weeks 14-64

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	week 0-14
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.	week 0-14
Proportion of participants achieving endoscopic improvement (defined as endoscopic subscore = 0 or 1) at Week 14.	week 0-14
Proportion of participants achieving endoscopic remission (defined as endoscopic subscore = 0) at Week 14.	week 0-14
PF 06480605 trough concentrations during the induction period through Week 14.	week 0-14
Change from baseline in fecal calprotectin during the induction period through Week 14.	week 0-14
Change from baseline in hsCRP during the induction period through Week 14.	week 0-14
Change from baseline in serum sTL1A during the induction period through Week 14.	week 0-14
Incidence of development of anti drug antibodies (ADAs) and neutralizing antibodies (NAbs) during the induction period through Week 14.	week 0-14
Proportion of participants achieving clinical remission (defined as a Total Mayo Score >/= to 2, with no individual subscore >1) at Week 56.	Weeks 14-56
Proportion of participants achieving sustained clinical remission (ie, clinical remission at both Week 14 and Week 56).	Weeks 14-56
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.	Weeks 14-56
Proportion of participants achieving sustained remission-FDA definition 1 (ie, remission-FDA definition 1 at both Week 14 and Week 56).	Weeks 14-56
Proportion of participants achieving sustained remission-FDA definition 2 (ie, remission-FDA definition 2 at both Week 14 and Week 56).	Weeks 14-56
Proportion of participants achieving endoscopic improvement (defined as endoscopic subscore = 0 or 1) at Week 56.	Weeks 14-56
Proportion of participants achieving sustained endoscopic improvement (ie, endoscopic improvement at both Week 14 and Week 56).	Weeks 14-56
Proportion of participants achieving endoscopic remission (defined as endoscopic sub-score = 0) at Week 56.	Weeks 14-56
Proportion of participants achieving sustained endoscopic remission (ie, endoscopic remission at both Week 14 and Week 56).	Weeks 14-56
PF-06480605 concentration from Week 14 through the End of Study Visit.	Weeks 14-64
Change from Week 14 in fecal calprotectin during the chronic therapy period through the End of Study Visit	Weeks 14-64
Change from Week 14 in hsCRP during the chronic therapy period through the End of Study Visit.	Weeks 14-64
Change from week 14 in serum sTL1A during the chronic therapy period through the End of Study Visit.	Weeks 14-64
Change from baseline through the End of the Study Visit in fecal calprotectin	weeks 14-64
Change from baseline through the End of the Study Visit in hsCRP.	Weeks 14-64
Change from baseline through the End of Study Visit in serum sTL1A.	Weeks 14-64
Incidence of development of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) from Week 14 through the End of Study Visit.	Weeks 14-64

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2019
• Primary Completion (Actual): October 25, 2022
• Study Completion (Actual): October 25, 2022

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: B7541007; TL1A (Other Identifier: Alias Study Number); Tuscany 2 (Other Identifier: Alias Study Number); 2019-002698-74 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No