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 Department
    • Manizales, Caldas Department, Colombia, 170004
      • Asociacion IPS Medicos Internistas de Caldas
• France
  • Amiens, France, 80054
    • CHU d'Amiens-Picardie - SITE SUD
  • Lille, France, 59037
    • Centre Hospitalier Regional Universitaire (CHU) de Lille - CIC
  • Lille, France, 59037
    • Centre Hospitalier Regional Universitaire (CHU) de Lille - Hopital Claude Huriez
  • Lille, France, 59037
    • Centre Hospitalier Regional Universitaire (CHU) de Lille
  • Nantes, France, 44093
    • CHU Hotel-Dieu
  • Pierre-Bénite, France, 69495
    • Centre Hospitalier Lyon Sud
  • Pierre-Bénite, France, 69495
    • Centre Hospitalier Universitaire de Lyon Sud
• Germany
  • Berlin, Germany, 14050
    • Deutsches Rotes Kreuz Schwesternschaft Berlin Gemeinnützige Krankenhaus GmbH
  • Halle, Germany, 06108
    • Studiengesellschaft BSF Unternehmergesellschaft
  • Halle, Germany, 06108
    • Studiengesellschaft BSF UG (haftungsbeschränkt)
• Hungary
  • Ajka, Hungary, 8400
    • Magyar Imre Kórház
  • Budapest, Hungary, H-1033
    • Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.
  • Szekszárd, Hungary, 7100
    • Clinfan Kft.
  • Székesfehérvár, Hungary, 8000
    • Life Egészségcentrum
  • Tapolca, Hungary, 8300
    • Deák Jenő Kórház
  • Tatabánya, Hungary, H-2800
    • Clinexpert Tatabanya, Szent Borbala Hospital
  • Veszprém, Hungary, 8200
    • Szofia Private Clinic
  • Veszprém megye
    • Balatonfüred, Veszprém megye, 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
  • 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
  • Padua, 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-ken
    • Nagakute, Aichi-ken, 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
  • Mexico City, Mexico, 01120
    • Karla Adriana Espinosa Bautista
  • Querétaro, Mexico, 76070
    • SMIQ S. de R.L. de C.V.
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44600
      • BRCR Global Mexico
  • Yucatán
    • Mérida, Yucatán, Mexico, 97130
      • Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion
• Poland
  • Bialystok, Poland, 15-704
    • KLIMED Marek Klimkiewicz
  • Knurów, Poland, 44-190
    • Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
  • Knurów, Poland, 44-190
    • MZ Badania Slowik Zymla Sp. j.
  • Sopot, Poland, 81-756
    • ENDOSKOPIA Sp. z o. o.
  • Szczecin, Poland, 71-434
    • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Warsaw, Poland, 00-728
    • WIP Warsaw IBD Point Profesor Kierkus
  • Warsaw, Poland, 03-580
    • NZOZ VIVAMED Jadwiga Miecz
  • Wroclaw, Poland, 50-449
    • Centrum Medyczne Melita Medical
• Romania
  • Bucharest, Romania, 020125
    • Spitalul Clinic Colentina
  • Bucharest, Romania, 010719
    • Medlife S.A.
• Russia
  • Moscow, Russia, 115419
    • KDC "Evromedservis", OJSC
  • Novosibirsk, Russia, 630005
    • Limited Liability Company "Medicinsky Center SibNovoMed"
  • Novosibirsk, Russia, 630007
    • LLC Novosibirskiy Gastrocenter
  • Omsk, Russia, 644050
    • Clinic of OSMU
  • Perm, Russia, 614109
    • Perm Clinical Centre of the Federal Medical-Biological Agency
  • Samara, Russia, 443029
    • Private Healthcare Institution "Clinical Hospital" Russian Railways-Medicine "Samara city"
  • Saratov, Russia, 410054
    • Clinical Hospital named after S.R. Mirotvortsev
  • Smolensk, Russia, 214019
    • Research Institute of Antimicrobial Chemotherapy
  • Tomsk, Russia, 634063
    • Tomsk Regional Clinical Hospital
  • Tyumen, Russia, 625007
    • City Hospital JSC "Medical centre"
  • Yaroslavl, Russia, 150062
    • SBHI YaR "Regional Clinical Hospital"
  • Stavropol Kray
    • Pyatigorsk, Stavropol Kray, Russia, 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.
  • Prešov, Slovakia, 080 01
    • Gastro LM s.r.o
  • Vranov nad Topľou, Slovakia, 093 01
    • Endomed, s.r.o.
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • IATROS International
    • Bloemfontein, Free State, South Africa, 9301
      • Dr van Dyk & Partners Inc
    • 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
  • Changwat Songkhla
    • Hat Yai, Changwat Songkhla, Thailand, 90110
      • Songklanagarind Hospital, Prince of Songkla University
• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34093
    • Istanbul Universitesi Istanbul Tip Fakultesi
  • Istanbul, Turkey (Türkiye), 34093
    • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
  • Kocaeli, Turkey (Türkiye), 41380
    • Kocaeli Universitesi Tip Fakultesi, Ic Hastaliklari Anabilim Dali
  • Mersin, Turkey (Türkiye), 33110
    • Mersin Universitesi Tip Fakultesi Hastanesi
  • Zonguldak, Turkey (Türkiye), 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: 14 years to 71 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	Measure Description	Time Frame
Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14	Clinical remission was defined as total Mayo Score ≤2, with no individual subscore >1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and physician's global assessment (PGA) subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.	At Week 14
Induction Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.	From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.)
Induction Period: Number of Participants With Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.	From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.)
Induction Period: Number of Participants With AEs or SAEs Leading to Discontinuation	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Participants who had an AE/SAE that led to study discontinuation have been reported here. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.	From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.)
Chronic Period: Number of Participants With TEAEs	TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.	From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)
Chronic Period: Number of Participants With SAEs	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.	From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)
Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Participants who had an AE/SAE that led to study discontinuation have been reported here. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.	From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1)	Modified remission 1 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), stool frequency subscore = 0 (normal number of stools per day), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.	Induction Period: At Week 14; Chronic Period: At Week 56
Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2)	Modified remission 2 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 (normal number of stools per day) or 1 (1 or 2 more stools than normal), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.	Induction Period: At Week 14; Chronic Period: At Week 56
Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement	Endoscopic improvement was defined as an endoscopic subscore of 0 (Normal or inactive disease) or 1 (Mild disease [erythema, decreased vascular pattern, mild friability]) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Percentages have been rounded off to the nearest whole number.	Induction Period: At Week 14; Chrnoic Period: At Week 56
Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission	Endoscopic remission was defined as an endoscopic subscore of 0 (Normal or inactive disease) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Percentages have been rounded off to the nearest whole number.	Induction Period: At Week 14; Chronic Period: At Week 56
Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605		Induction Period: 30 mins postdose on Day 1, Weeks 4, 8, 12 and 14; Chronic Period: 30 mins postdose on Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48; End of Treatment (EOT) (Week 52) and Follow-up (FU) Visits 1 (Week 56), 2 (Week 60) and 3 (Week 64)
Induction Period: Change From Baseline in Fecal Calprotectin		Baseline, Weeks 4, 8, and 12
Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)		Baseline, Weeks 4, 8, and 12
Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A)		Baseline, Weeks 4, 8, and 12
Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605	Samples were considered to be positive for ADA against PF-06480605 if the titer was ≥ 60, and an ADA sample was considered to be negative if the titer was < 60. Samples were considered to be positive for NAb against PF-06480605 if the titer was ≥ 5, and an NAb sample was considered to be negative if the titer was < 5.	Baseline, Weeks 4, 8, 12, 14
Chronic Period: Percentage of Participants Who Achieved Clinical Remission	Clinical remission was defined as total Mayo Score ≤2, with no individual subscore >1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.	At Week 56
Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission	Clinical remission was defined as total Mayo Score ≤2, with no individual subscore >1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.	At Weeks 14 and 56
Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 1 (Modified Remission 1)	Modified remission 1 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), stool frequency subscore = 0 (normal number of stools per day), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.	At Weeks 14 and 56
Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 2 (Modified Remission 2)	Modified remission 2 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 (normal number of stools per day) or 1 = 1 or 2 more stools than normal, and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.	At Weeks 14 and 56
Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement	Endoscopic improvement was defined as an endoscopic subscore of 0 (Normal or inactive disease) or 1 (Mild disease [erythema, decreased vascular pattern, mild friability]) at both Week 14 and Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Participants with sustained endoscopic improvement were defined as those who achieved improvement at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.	At Weeks 14 and 56
Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission	Endoscopic remission was defined as an endoscopic subscore of 0 (Normal or inactive disease) at both Week 14 and Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Participants with sustained endoscopic remission were defined as those who achieved endoscopic remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.	At Weeks 14 and 56
Chronic Period: Change From Week 16 in Fecal Calprotectin		Week 16 (baseline), Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, and 64
Chronic Period: Change From Week 14 in hsCRP		Week 14 (baseline), Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64
Chronic Period: Change From Week 14 in Serum sTL1A		Week 14 (baseline), Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64
Change From Baseline in Fecal Calprotectin Through the End of Study		Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, and 64
Change From Baseline in hsCRP Through the End of Study		Baseline, Weeks 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64
Change From Baseline in Serum sTL1A Through the End of Study		Baseline, Weeks 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64
Chronic Period: Number of Participants With ADA and NAbs to PF-06480605	Samples were considered to be positive for ADA against PF-06480605 if the titer was ≥ 60, and an ADA sample was considered to be negative if the titer was < 60. Samples were considered to be positive for NAb against PF-06480605 if the titer was ≥ 5, and an NAb sample was considered to be negative if the titer was < 5.	Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Pfizer
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General Publications

• Danese S, Allegretti JR, Schreiber S, Peyrin-Biroulet L, Jairath V, D'Haens G, Kierkus J, Leong RW, Yarur AJ, Vincent MS, Banerjee A, Chandra DE, Peeva E, Neelakantan S, Hung KE, McBride JM, Bojic D, Lasch K, Schiffman C, Feagan BG. Anti-TL1A antibody, afimkibart, in moderately-to-severely active ulcerative colitis (TUSCANY-2): a multicentre, double-blind, treat-through, multi-dose, randomised, placebo-controlled, phase 2b trial. Lancet Gastroenterol Hepatol. 2025 Oct;10(10):882-895. doi: 10.1016/S2468-1253(25)00129-3. Epub 2025 Jul 21.

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 (Estimated): December 16, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

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: XA45397; B7541007 (Other Identifier: Previous Study ID); 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)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

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