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
5 other identifiers
interventional
246
23 countries
166
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2019
Typical duration for phase_2
166 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2019
CompletedFirst Posted
Study publicly available on registry
September 16, 2019
CompletedStudy Start
First participant enrolled
December 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2022
CompletedResults Posted
Study results publicly available
December 16, 2025
CompletedDecember 16, 2025
November 1, 2025
2.9 years
September 12, 2019
October 22, 2025
November 27, 2025
Conditions
Outcome Measures
Primary Outcomes (7)
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 Outcomes (22)
Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1)
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)
Induction Period: At Week 14; Chronic Period: At Week 56
Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement
Induction Period: At Week 14; Chrnoic Period: At Week 56
Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission
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)
- +17 more secondary outcomes
Study Arms (9)
Cohort 1
EXPERIMENTALInduction - Placebo SC Q4W, (sub-cutaneous every 4 weeks) Chronic- PF-06480605 50 mg SC Q4W
Cohort 2
EXPERIMENTALInduction - Placebo SC Q4W, Chronic- PF-06480605 150 mg SC Q4W
Cohort 3
EXPERIMENTALInduction - Placebo SC Q4W, Chronic- PF-06480605 450 mg SC Q4W
Cohort 4
PLACEBO COMPARATORInduction- PF-06480605 50 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W
Cohort 5
EXPERIMENTALInduction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W
Cohort 6
EXPERIMENTALInduction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W
Cohort 7
EXPERIMENTALInduction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W
Cohort 8
EXPERIMENTALInduction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W
Cohort 9
EXPERIMENTALInduction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 450 mg SC Q4W
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Pfizercollaborator
Study Sites (166)
Digestive Health Specialists
Dothan, Alabama, 36301, United States
Dothan Surgery Center
Dothan, Alabama, 36301, United States
Flowers Hospital
Dothan, Alabama, 36305, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72204, United States
Surinder Saini, M.D., Inc.
Newport Beach, California, 92660, United States
Endoscopy Center of Connecticut, LLC
Guilford, Connecticut, 06437, United States
Endoscopy Center of Connecticut, LLC
Hamden, Connecticut, 06518, United States
Medical Research Center Of Connecticut, LLC
Hamden, Connecticut, 06518, United States
PACT Gastroenterology Center
Hamden, Connecticut, 06518, United States
Whitney Imaging
Hamden, Connecticut, 06518, United States
Medycal Research Inc.
Brooksville, Florida, 34613, United States
Safety Harbor Surgery
Clearwater, Florida, 33761, United States
Trident Care
Clearwater, Florida, 33762, United States
Tower Radiology Center
Oldsmar, Florida, 34677, United States
Akumin
Tampa, Florida, 33603, United States
Tampa Bay Endoscopy Center
Tampa, Florida, 33603, United States
Alliance Clinical Research of Tampa
Tampa, Florida, 33615, United States
Gastroenterology Consultants P.C.
Roswell, Georgia, 30076, United States
The University of Chicago Medical Center (clinic address)
Chicago, Illinois, 60637, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Brigham and Women's Hospital - Office
Boston, Massachusetts, 02115, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Michigan Endoscopy Center
Farmington Hills, Michigan, 48334, United States
Valley View Surgery Center
Las Vegas, Nevada, 89102, United States
Sierra Clinical Research
Las Vegas, Nevada, 89106, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, 10021, United States
Weill Cornell Medical College
New York, New York, 10021, United States
New York Presbyterian Hospital - Weill Cornell Medical Center
New York, New York, 10065, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, 10065, United States
Weill Cornell Medical College- New York Presbyterian Hospital
New York, New York, 10065, United States
Investigational Drug Services
Philadelphia, Pennsylvania, 19104, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
Gastroenterology Associates, PA of Greenville
Greenville, South Carolina, 29607, United States
Vanderbilt GI Endoscopy Lab at One Hundred Oaks
Nashville, Tennessee, 37204, United States
Vanderbilt Heart One Hundred Oaks
Nashville, Tennessee, 37204, United States
Vanderbilt Inflammatory Bowel Disease Clinic
Nashville, Tennessee, 37204, United States
Vanderbilt Laboratory Services North One Hundred Oaks
Nashville, Tennessee, 37204, United States
Vanderbilt One Hundred Oaks Imaging
Nashville, Tennessee, 37204, United States
Vanderbilt University Medical Center - GI Research Office
Nashville, Tennessee, 37212-1610, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Vanderbilt University Med. Center
Nashville, Tennessee, 37232-5543, United States
Vanderbilt University Medical Center- Heart Station (ECG)
Nashville, Tennessee, 37232, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
PrimeCare Medical Group
Houston, Texas, 77024, United States
Gastroenterology Consultants of San Antonio, PA
San Antonio, Texas, 78230, United States
VIP Trials
San Antonio, Texas, 78230, United States
South Texas Radiology Imaging Centers
San Antonio, Texas, 78258, United States
Gastroenterology Associates of Northern VA
Fairfax, Virginia, 22031, United States
Gastroenterology Associates of Northern Virginia
Fairfax, Virginia, 22031, United States
Verity Research, Inc.
Fairfax, Virginia, 22031, United States
Medical Diagnostic Imaging
Wauwatosa, Wisconsin, 53222, United States
Allegiance Internal Medicine and Allegiance Research Specialists
Wauwatosa, Wisconsin, 53226, United States
GI Associates
Wauwatosa, Wisconsin, 53226, United States
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Mater Misericordiae Ltd.
South Brisbane, Queensland, 4101, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
University Hospitals Leuven/Department of Gastroenterology
Leuven, 3000, Belgium
"ACIBADEM City Clinic Diagnostic-Consultative Center" EOOD
Sofia, 1784, Bulgaria
Asociacion IPS Medicos Internistas de Caldas
Manizales, Caldas Department, 170004, Colombia
CHU d'Amiens-Picardie - SITE SUD
Amiens, 80054, France
Centre Hospitalier Regional Universitaire (CHU) de Lille - CIC
Lille, 59037, France
Centre Hospitalier Regional Universitaire (CHU) de Lille - Hopital Claude Huriez
Lille, 59037, France
Centre Hospitalier Regional Universitaire (CHU) de Lille
Lille, 59037, France
CHU Hôtel-Dieu
Nantes, 44093, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Centre Hospitalier Universitaire de Lyon Sud
Pierre-Bénite, 69495, France
Deutsches Rotes Kreuz Schwesternschaft Berlin Gemeinnützige Krankenhaus GmbH
Berlin, 14050, Germany
Studiengesellschaft BSF UG (haftungsbeschränkt)
Halle, 06108, Germany
Studiengesellschaft BSF Unternehmergesellschaft
Halle, 06108, Germany
DRC Gyogyszervizsgalo Kozpont Kft.
Balatonfüred, Veszprém megye, 8230, Hungary
Magyar Imre Kórház
Ajka, 8400, Hungary
Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.
Budapest, H-1033, Hungary
Clinfan Kft.
Szekszárd, 7100, Hungary
Life Egészségcentrum
Székesfehérvár, 8000, Hungary
Deák Jenő Kórház
Tapolca, 8300, Hungary
Clinexpert Tatabanya, Szent Borbala Hospital
Tatabánya, H-2800, Hungary
Szofia Private Clinic
Veszprém, 8200, Hungary
Shree Giriraj Multispeciality Hospital
Rajkot, Gujarat, 360005, India
Surat Institute of Digestive Sciences
Surat, Gujarat, 395002, India
Gujarat Hospital Gastro and Vascular Centre, Opp. Shree Ram Petrol Pump
Surat, Gujarat, 395009, India
M.S. Ramaiah Medical College and Hospitals
Bangalore, Karnataka, 560054, India
Grant Medical Foundation, Ruby Hall Clinic
Pune, Maharashtra, 411001, India
S.R. Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302001, India
S.M.S. Medical College & Hospital
Jaipur, Rajasthan, 302004, India
IRCCS "Saverio de Bellis", UOC Gastroenterologia
Castellana Grotte, BARI, 70013, Italy
Istituto Clinico Humanitas Centro per le Malattie Infiammatorie Croniche dell'Intestino - IBD Cent
Rozzano, Milan, 20089, Italy
A.O.U. dell'Università degli Studi della Campania "Luigi Vanvitelli"
Naples, Naples, 80138, Italy
Policlinico Universitario Campus Bio-Medico di Roma
Roma, RM, 00128, Italy
UO Malattie retto-Intestinali Ospedale "Sacro Cuore-don Calabria"
Negrar, Verona, 37024, Italy
Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
Padua, 35128, Italy
Aichi Medical University Hospital
Nagakute, Aichi-ken, 480-1195, Japan
Toho University Sakura Medical Center
Sakura, Chiba, 285-8741, Japan
Kurume University Hospital
Kurume, Fukuoka, 830-0011, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543, Japan
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, 983-8520, Japan
Tokyo Medical And Dental University Hospital
Bunkyo-ku, Tokyo, 113-8519, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
BRCR Global Mexico
Guadalajara, Jalisco, 44600, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion
Mérida, Yucatán, 97130, Mexico
Karla Adriana Espinosa Bautista
Mexico City, 01120, Mexico
Smiq S. de R.L. de C.V.
Querétaro, 76070, Mexico
KLIMED Marek Klimkiewicz
Bialystok, 15-704, Poland
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
Knurów, 44-190, Poland
MZ Badania Slowik Zymla Sp. j.
Knurów, 44-190, Poland
ENDOSKOPIA Sp. z o. o.
Sopot, 81-756, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728, Poland
NZOZ Vivamed Jadwiga Miecz
Warsaw, 03-580, Poland
Centrum Medyczne Melita Medical
Wroclaw, 50-449, Poland
Medlife S.A.
Bucharest, 010719, Romania
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Pyatigorsk City Clinical Hospital
Pyatigorsk, Stavropol Kray, 357500, Russia
KDC "Evromedservis", OJSC
Moscow, 115419, Russia
Limited Liability Company "Medicinsky Center SibNovoMed"
Novosibirsk, 630005, Russia
LLC Novosibirskiy Gastrocenter
Novosibirsk, 630007, Russia
Clinic of OSMU
Omsk, 644050, Russia
Perm Clinical Centre of the Federal Medical-Biological Agency
Perm, 614109, Russia
Private Healthcare Institution "Clinical Hospital" Russian Railways-Medicine "Samara city"
Samara, 443029, Russia
Clinical Hospital named after S.R. Mirotvortsev
Saratov, 410054, Russia
Research Institute of Antimicrobial Chemotherapy
Smolensk, 214019, Russia
Tomsk Regional Clinical Hospital
Tomsk, 634063, Russia
City Hospital JSC "Medical centre"
Tyumen, 625007, Russia
SBHI YaR "Regional Clinical Hospital"
Yaroslavl, 150062, Russia
Klinicki Centar Kragujevac
Kragujevac, 34000, Serbia
Opsta Bolnica Subotica
Subotica, 24000, Serbia
Opsta Bolnica "Djordje Joanovic", Odeljenje Interno, Odsek Gastroenterologija
Zrenjanin, 23000, Serbia
KM Management spol. s.r.o.
Nitra, 949 01, Slovakia
Gastro LM s.r.o
Prešov, 080 01, Slovakia
ENDOMED, s.r.o.
Vranov nad Topľou, 093 01, Slovakia
Dr van Dyk & Partners Inc
Bloemfontein, Free State, 9301, South Africa
IATROS International
Bloemfontein, Free State, 9301, South Africa
Universitas Private Hospital
Bloemfontein, Free State, 9301, South Africa
Ahmed Kathrada Private Hospital
Johannesburg, Gauteng, 1827, South Africa
Lenasia Clinical Trial Centre
Johannesburg, Gauteng, 1827, South Africa
Arwyp Medical Centre
Kempton Park, Gauteng, 1619, South Africa
Clinresco Centres (Pty) Ltd
Kempton Park, Gauteng, 1619, South Africa
Emmed Research
Pretoria, Gauteng, 0002, South Africa
Radiology24 Jakaranda Hospital
Pretoria, Gauteng, 0002, South Africa
Mediclinic Kloof Hospital
Pretoria, Gauteng, 0048, South Africa
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942, Spain
King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University
Pathum Wan, Bangkok, 10330, Thailand
Songklanagarind Hospital, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110, Thailand
Phramongkutklao Hospital
Bangkok, 10400, Thailand
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Istanbul, 34093, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, 34093, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi, Ic Hastaliklari Anabilim Dali
Kocaeli, 41380, Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin, 33110, Turkey (Türkiye)
Bulent Ecevit Universitesi Tip Fakultesi
Zonguldak, 67600, Turkey (Türkiye)
Municipal non-profit enterprise of Kharkiv regional council "Regional clinical hospital"
Kharkiv, 61024, Ukraine
Municipal non-profit enterprise "City clinical hospital #2 named after O.O.Shalimov"
Kharkiv, 61037, Ukraine
Medical Centre Medical Clinic Blagomed LLC
Kyiv, 01023, Ukraine
Municipal Non-profit Enterprise "Kyiv City Clinical Hospital #1"
Kyiv, 02091, Ukraine
Municipal Non-profit enterprise of Kyiv Regional Council "Kyiv regional hospital"
Kyiv, 04078, Ukraine
Municipal non-profit enterprise of Kyiv regional council "Kyiv regional clinical hospital"
Kyiv, 04107, Ukraine
Medical center of Limited Liability Company "Health Clinic", medical clinical research center
Vinnytsia, 21009, Ukraine
Medical Centre "DIACENTER" LLC
Zaporizhzhia, 69076, Ukraine
Endoscopy Facility - Spire Little Aston Hospital
Sutton Coldfield, Birmingham, B74 3UP, United Kingdom
MeDiNova North London Quality Research Site
Northwood, Middlesex, HA6 2RN, United Kingdom
MeDiNova Northamptonshire Quality Research Site
Corby, NN18 9EZ, United Kingdom
Egin Research Ltd
High Wycombe, HP11 2QW, United Kingdom
Chest X-ray Facility - BMI Bishops Wood Hospital
Northwood, HA6 2JW, United Kingdom
Spire Nottingham Hospital
Nottingham, NG12 4GA, United Kingdom
Endoscopy Facility - Orpington Endoscopy Centre
Orpington, BR5 3TW, United Kingdom
Related Publications (1)
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.
PMID: 40706613DERIVED
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2019
First Posted
September 16, 2019
Study Start
December 19, 2019
Primary Completion
October 25, 2022
Study Completion
October 25, 2022
Last Updated
December 16, 2025
Results First Posted
December 16, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
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