AzTrials
AzTrials

Ulcerative ColitisPhase 3FIGARO UC 301NCT03259334

Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis

A Phase 3 study testing Ontamalimab in people with Ulcerative Colitis, run by Shire at 207 sites in 18 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of participant-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC). Read more about this study

Who is it for?
Ages 16 to 80 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Ontamalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
380 participants
Where
207 sitesin 18 countries
Study dates
9 Feb 2018to 23 Oct 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

  • Ages 16 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Participants and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
  • Participants must be able to voluntarily provide written, signed, and dated informed consent and/or assent, as applicable, to participate in the study.
  • Participants must be between greater than or equal to (>=)16 and <=80 years of age at the time of the signing of the informed consent/assent form.
  • Participants less than (<) 18 years of age must weigh >=40 kg and must have body mass index (BMI) >=16.5 kilogram per square meter (kg/m^2).
  • Participants must have a documented diagnosis of UC for >=3 months before screening. The following must be available in each participant's source documentation:
  • A biopsy report to confirm the histological diagnosis.
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  • A report documenting disease duration based upon prior colonoscopy. Note: If this documentation is not available at the time of screening, a colonoscopy with biopsy to confirm the diagnosis is required during the screening period.
  • Participants must be willing to undergo a flexible sigmoidoscopy or colonoscopy, including biopsy sample collection, during screening after all other inclusion criteria have been met.
  • Participants must have moderate to severe active UC, defined as a total Mayo score of >=6, including a centrally read endoscopic subscore >=2, rectal bleeding subscore >=1, and stool frequency subscore >=1 at baseline.
  • Participants must have evidence of UC extending proximal to the rectum (ie, not limited to proctitis).
  • Participants must have had an inadequate response to, or lost response to, or had an intolerance to at least 1 conventional treatment such as mesalamine (5-aminosalicylate [ASA]), glucocorticoids, immunosuppressants (azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]), or anti-tumor necrosis factor (TNF).
  • Participants receiving any treatment(s) for UC are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
  • Participants are males or nonpregnant, nonlactating females who, if sexually active, agree to comply with the contraceptive requirements of the protocol, or females of nonchildbearing potential.

Who cannot join

  • Participants with indeterminate colitis, microscopic colitis, non-steroidal anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis, or clinical/histologic findings suggestive of Crohn's disease.
  • Participants with colonic dysplasia or neoplasia. (Participants with prior history of adenomatous polyps will be eligible if the polyps have been completely removed.)
  • Participants with past medical history or presence of toxic megacolon.
  • Participants with colonic stricture, past medical history of colonic resection, a history of bowel surgery within 6 months before screening, or who are likely to require surgery for UC during the treatment period.
  • Participants at risk for colorectal cancer must have a colonoscopy performed during the screening period with results available within 10 days before the baseline visit, unless the participant has had a surveillance colonoscopy performed within 1 year prior to screening, and any adenomatous polyps found at that examination have been excised. Colonoscopy report and pathology report (if biopsies are obtained) from the colonoscopy performed during screening or in the prior year confirming no evidence of dysplasia and colon cancer must be available in the source documents.
  • Participants at risk for colorectal cancer include, but are not limited to:
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  • Participants with extensive colitis for >=8 years or disease limited to left side of colon (ie, distal to splenic flexure) for >=10 years before screening, regardless of age.
  • Participants >=50 years of age at the time of signing of the informed consent form.
  • Participants have had prior treatment with SHP647.
  • Participants with known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients.
  • Participants have received anti-TNF treatment within 60 days before baseline.
  • Participants have received any biologic with immunomodulatory properties (other than anti-TNFs) within 90 days before baseline.
  • Participants have received any nonbiologic treatment with immunomodulatory properties (other than their current background UC treatment) within 30 days before baseline.
  • Participants have ever received anti-integrin/adhesion molecule treatment (example (eg): natalizumab, vedolizumab, efalizumab, etrolizumab, or any other investigational anti-integrin/adhesion molecule).
  • Participants have received parenteral or rectal glucocorticoids, or rectal 5-ASA, within 14 days before screening endoscopic procedure.
  • Participants have received leukocyte apheresis or selective lymphocyte, monocyte, or granulocyte apheresis or plasma exchange within 30 days before baseline.
  • Participants have participated in other investigational studies within either 30 days or 5 half-lives of investigational product used in the study (whichever is longer) before baseline.
  • Participants have received a live (attenuated) vaccine within 30 days before the baseline visit.
  • Participants with active enteric infections (positive stool culture and sensitivity), Clostridium difficile infection or pseudomembranous colitis [Participants with C. difficile infection at screening may be allowed re-test after treatment], evidence of active cytomegalovirus infection or Listeria monocytogenes, known active invasive fungal infections such as histoplasmosis or parasitic infections, clinically significant underlying disease that could predispose the participants to infections, or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks before the baseline visit.
  • Participants with abnormal chest x-ray findings at screening, such as presence of active tuberculosis, general infections, heart failure, or malignancy.
  • Participants with evidence of active or latent infection with Mycobacterium tuberculosis (TB) or participants with this history who have not completed a generally accepted full course of treatment before randomization are excluded. All other participants must have either the Mantoux (purified protein derivative [PPD]) tuberculin skin test or interferon gamma release assay (IGRA) performed.
  • Participants who have no history of previously diagnosed active or latent tuberculosis are excluded if they have a positive Mantoux (PPD) tuberculin skin test (ie >=5 millimeter [mm] induration) or a positive IGRA (the latter to be tested at the site's local laboratory) during screening or within 12 weeks before screening. If IGRA test cannot be performed locally, a central laboratory may be used, with prior agreement from the sponsor.
  • An IGRA is strongly recommended for participants with a prior Bacillus Calmette-Guerin (BCG) vaccination, but may be used for any participant. Documentation of IGRA product used and the test result must be in the participant's source documentation if performed locally. Acceptable IGRA products include QuantiFERON TB Gold Plus In-Tube Test.
  • If the results of the IGRA are indeterminate, the test may be repeated, and if a negative result is obtained, enrollment may proceed. In participants with no history of treated active or latent tuberculosis, a positive test on repeat will exclude the participant. Participants with a history of active or latent TB infection must follow instructions for "participants with a prior diagnosis of active or latent TB are excluded unless both of the following criteria are met" in this criterion.
  • Participants with repeat indeterminate IGRA results, with no prior TB history, may be enrolled after consultation with a pulmonary or infectious disease specialist who determines low risk of infection (ie, participant would be acceptable for immunosuppressant [eg, anti-TNF] treatment without additional action). This consultation must be included in source documentation.
  • Results from a chest x-ray, taken within the 12 weeks before or during screening must show no abnormalities suggestive of active TB infection as determined by a qualified medical specialist.
  • Participants with a prior diagnosis of active or latent TB are excluded unless both of the following criteria are met:
  • The participant has previously received an adequate course of treatment for either latent (eg, 9 months of isoniazid or an acceptable alternative regimen, in a locale where rates of primary multidrug TB resistance are <5%. Participants from regions with higher rates of primary multidrug TB resistance are excluded) or active (acceptable multidrug regimen) TB infection. Evidence of diagnosis and treatment must be included in source documentation. Consultation with a pulmonary or infectious disease specialist to confirm adequate treatment (ie, participant would be acceptable for immunosuppressant [eg, anti-TNF] treatment without additional action) must be performed during the screening period. The consultation report must be included in source documentation prior to enrollment.
  • A chest x-ray performed within 12 weeks before or during screening indicates no evidence of active or recurrent disease, and documentation of interpretation by a qualified medical specialist must be included in source documentation.
  • Participants with a pre-existing demyelinating disorder such as multiple sclerosis or new onset seizures, unexplained sensory motor, or cognitive behavioral, neurological deficits, or significant abnormalities noted during screening.
  • Participants with any unexplained symptoms suggestive of progressive multifocal leukoencephalopathy (PML) based on the targeted neurological assessment during the screening period.
  • Participants with a transplanted organ. Skin grafts to treat pyoderma gangrenosum are allowed.
  • Participants with a significant concurrent medical condition at the time of screening or baseline, including, but not limited to, the following:
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  • Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg, Felty's syndrome], or local active infection/infectious illness) that, in the investigator's judgment will substantially increase the risk to the participant if he or she participates in the study.
  • Cancer or history of cancer or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
  • Presence of acute coronary syndrome (eg, acute myocardial infarction, unstable angina pectoris) within 24 weeks before screening.
  • History of significant cerebrovascular disease within 24 weeks before screening.
  • Participants who have had significant trauma or major surgery within 4 weeks before the screening visit, or with any major elective surgery scheduled to occur during the study.
  • Participants with evidence of cirrhosis with or without decompensation.
  • Participants with primary sclerosing cholangitis.
  • Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb).
  • Note: If a participant tests negative for HBsAg, but positive for hepatitis B virus (HBcAb), the participant would be considered eligible if no presence of HBV DNA is confirmed by HBV DNA polymerasechainreaction(PCR) reflex testing performed in the central laboratory.
  • Participants with chronic hepatitis C (HCV) (positive HCVAb and HCVRNA). Note: Participants who are HCVAb positive without evidence of HCVRNA may be considered eligible (spontaneous viral clearance or previously treated and cured [defined as no evidence of HCV RNA at least 12 weeks prior to baseline]).
  • Participants with any of the following abnormalities in hematology and/or serum chemistry profiles during screening.
  • Note: Screening laboratory tests, if the results are considered by the investigator to be transient and inconsistent with the participant's clinical condition, may be repeated once during the screening period for confirmation. Results must be reviewed for eligibility prior to the screening endoscopy procedure.
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels >=3.0×upper limit of normal (ULN).
  • Total bilirubin level >=1.5×ULN or >2.0×ULN if the participant has a known documented history of Gilbert's syndrome.
  • Hemoglobin level <=80 gram per liter (g/L) (8.0 gram per deciliter [g/dL]).
  • Platelet count <=100×10^9 per liter (/L) (100,000 cells per cubic millimeter [mm^3]) or >=1000×10^9/L (1,000,000 cells/mm^3).
  • White blood cell count <=3.5×10^9/L (3500 cells/mm^3). - Absolute neutrophil count (ANC)<2×10^9/L (2000 cells/mm^3).
  • Serum creatinine level >1.5 × ULN or estimated glomerular filtration rate <30 ml/min/1.73m^2 based on the abbreviated Modification of Diet in Renal Disease Study Equation.
  • Note: If platelet count is <150,000 cells/mm^3, a further evaluation should be performed to rule out cirrhosis, unless another etiology has already been identified.
  • Participants with known human immunodeficiency virus (HIV) infection based on documented history, with positive serological test, or positive HIV serologic test at screening, tested at the site's local laboratory in accordance with country requirements or tested at the central laboratory.
  • Note: A documented negative HIV test within 6 months of screening is acceptable and does not need to be repeated.
  • Participants who have, or who have a history of (within 2 years before screening), serious psychiatric disease, alcohol dependency, or substance/drug abuse or dependency of any kind, including abuse of medical marijuana (cannabis).
  • Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • Female participants who are planning to become pregnant during study period.
  • Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
  • Participants who are investigational site staff members or relatives of those site staff members or Participants who are Shire employees directly involved in the conduct of study.

Trial locations and contacts

207 sites in 18 countries.

207 sites in 18 countries

United States38 sites

  • Inquest Clinical Research/Coastal Gastroenterology Associates, PA

    Baytown, Texas, 77521

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • HP Clinical Research

    Bountiful, Utah, 84010

  • New York Total Medical Care PC

    Brooklyn, New York, 11215

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Consultants For Clinical Research Inc

    Cincinnati, Ohio, 45219

  • Consultants For Clinical Research Inc

    Cincinnati, Ohio, 45249

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80906

  • Asthma and Allergy Associates PC - CRN - PPDS

    Colorado Springs, Colorado, 80907

  • Gastrointestinal Diseases, Inc. Research

    Columbus, Georgia, 31904

  • Advanced Clinical Research Network

    Coral Gables, Florida, 33134

  • Northside Gastroenterology

    Cypress, Texas, 77429

  • Exemplar Research, Inc. - Elkins

    Elkins, West Virginia, 26241

  • Medisphere Medical Research Center LLC

    Evansville, Indiana, 47714

  • Consultants For Clinical Research Inc

    Fairfield, Ohio, 45014

  • Gastro One

    Germantown, Tennessee, 38138

  • Clinical Trials of SWLA LLC

    Lake Charles, Louisiana, 70601

  • OM Research LLC - Lancaster - ClinEdge - PPDS

    Lancaster, California, 93534

  • Atria Clinical Research - Clinedge - PPDS

    Little Rock, Arkansas, 72209

  • Nuren Medical and Research Center

    Miami, Florida, 33144

  • Laporte County Institute For Clinical Research

    Michigan City, Indiana, 46360

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Digestive Health Center PA

    Ocean Springs, Mississippi, 39564

  • Omega Research Consultants LLC - Clinedge - PPDS

    Orlando, Florida, 32810

  • Allegheny Center For Digestive Health

    Pittsburgh, Pennsylvania, 15212

  • Inland Empire Liver Foundation

    Rialto, California, 92377

  • East Coast Institute for Research, LLC

    Saint Augustine, Florida, 32086

  • Digestive Health Center at UWMC

    Seattle, Washington, 98195

  • University of Washington

    Seattle, Washington, 98195

  • Louisiana Research Center LLC

    Shreveport, Louisiana, 71105

  • Piedmont Healthcare

    Statesville, North Carolina, 28677

  • CHI Franciscan Digestive Care Associates

    Tacoma, Washington, 98405

  • DM Clinical Research - ERN - PPDS

    Tomball, Texas, 77375

  • Advanced Gastroenterology-Union City

    Union City, Tennessee, 38261

  • Digestive Disease Associates

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Poland35 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, Podlaskie Voivodeship, 15-276

  • Vitamed Galaj i Cichomski sp.j.

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079

  • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168

  • Centrum Medyczne Pratia Bydgoszcz

    Bydgoszcz, 85-796

  • Centrum Medyczne Czestochowa - PRATIA - PPDS

    Częstochowa, 42-200

  • Centrum Medyczne Gdynia - PRATIA - PPDS

    Gdynia, 81-338

  • Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii

    Gmina Końskie, Świętokrzyskie Voivodeship, 26-200

  • BioVirtus Centrum Medyczne

    Józefów, 05-410

  • Szpital Zakonu Bonifratrow pw. Aniolow Strozow w Katowicach

    Katowice, 40-211

  • NZOZ All Medicus

    Katowice, 40-659

  • Krakowskie Centrum Medyczne

    Krakow, Lesser Poland Voivodeship, 31-501

  • Centrum Medyczne A-Z Clinic Mateusz Sidor, Piotr Puc-Lekarze Spolka Partnerska

    Krakow, 31-315

  • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.

    Ksawerów, 95-054

  • Med Gastr Sp.z.o.o Sp.k

    Lodz, 91-034

  • Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny

    Lódz, Lódzkie, 90-302

  • SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej UM w Lodzi

    Lódz, Lódzkie, 90-647

  • Instytut Centrum Zdrowia Matki Polki

    Lódz, Lódzkie, 93-338

  • Twoja Przychodnia - Centrum Medyczne Nowa Sol

    Nowa Sól, 67-100

  • Centrum Innowacyjnych Terapii

    Piaseczno, 05-500

  • Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa

    Poznan

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, 35-302

  • Endoskopia Sp. z o.o.

    Sopot, Pomeranian Voivodeship, 81-756

  • Twoja Przychodnia - Szczecińskie Centrum Medyczne

    Szczecin, West Pomeranian Voivodeship, 71-434

  • Sonomed Sp. z o.o.

    Szczecin, 71-685

  • Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • H-T. Centrum Medyczne Endoterapia

    Tychy, Silesian Voivodeship, 43-100

  • Centrum Medyczne Warszawa - PRATIA - PPDS

    Warsaw, Masovian Voivodeship, 01-868

  • Niepubliczny Zakład Opieki Zdrowotnej VIVAMED

    Warsaw, Masovian Voivodeship, 03-580

  • Miedzyleski Szpital Specjalistyczny w Warszawie

    Warsaw, Masovian Voivodeship, 04-749

  • Centrum Zdrowia MDM

    Warsaw, 00-635

  • Centralny Szpital Kliniczny MSW

    Warsaw, 02-507

  • Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.

    Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800

  • Melita Medical

    Wroclaw, Lower Silesian Voivodeship, 50-449

  • Lexmedica

    Wroclaw, Lower Silesian Voivodeship, 53-114

  • Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II

    Zamość, 22-400

Other trials in Poland

Russia18 sites

  • Kazan State Medical University

    Kazan', 420064

  • Moscow Clinical Scientific Center

    Moscow, 111123

  • Moscow Regional Research Clinical Institute Na Mfvladimirskiy

    Moscow, 129110

  • Nizhegorodskaya Regional Clinical Hospital n.a. Semashko

    Nizhny Novgorod, 603126

  • Research Institute of Physiology and Basic Medicine

    Novosibirsk, 630117

  • Rostov State Medical University

    Rostov-on-Don, 344022

  • Rostov State Medical University

    Rostov-on-Don, 344091

  • Union Clinic, LLC

    Saint Petersburg, 191119

  • St. Elizabeth Municipal Clinical Hospital

    Saint Petersburg, 195257

  • First St. Petersburg State Medical University n.a. I.P Pavlov

    Saint Petersburg, 197022

  • Russian Medical Military Academy n.a. S.M. Kirov

    Saint Petersburg

  • Medical University Reaviz

    Samara, 443011

  • Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city

    Samara, 443029

  • Medical Company Hepatolog, LLC

    Samara, 443093

  • SHI Regional Clinical Hospital

    Saratov, 410053

  • Smolensk Regional Clinical Hospital

    Smoensk, 214018

  • Stavropol State Medical University

    Stavropol, 355017

  • Regional Consulting and Diagnostics Centre

    Tyumen, 625026

Other trials in Russia

Japan17 sites

  • Tokatsu Tsujinaka Hospital

    Abiko-shi, Chiba, 270-1168

  • Shinbeppu Hospital

    Beppu, Ôita, 874-0833

  • Hakodate Koseiin Hakodate Goryoukaku Hospital

    Hakodate, 040-0001

  • Yuai Memorial Hospital

    Koga, 306-0232

  • Kawabe Clinic

    Koganei, 184-0003

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya, 343-8555

  • Hidaka Coloproctology Clinic

    Kurume-shi, 839-0809

  • Jikei University Hospital

    Minato-ku, Tokyo, 105-8471

  • Kitasato University Kitasato Institute Hospital

    Minato-ku, Tokyo, 108-8642

  • Aichi Medical University Hospital

    Nagakute, 480-1195

  • Nishinomiya Municipal Central Hospital

    Nishinomiya, 663-8014

  • Ome Municipal General Hospital

    Ōme, Tokyo, 198-0042

  • Onomichi General Hospital

    Onomichi

  • Shiga University of Medical Science Hospital

    Ōtsu, 520-2192

  • Sagamihara Kyodo Hospital

    Sagamihara, Kanagawa, 252-5188

  • Sapporo Tokushukai Hospital

    Sapporo, Hokkaidô, 004-0041

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, 065-0033

Other trials in Japan

Italy15 sites

  • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliera Mater Domini Di Catanzaro

    Catanzaro, Calabria, 88100

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50134

  • Azienda Ospedaliero Universitaria Di Modena Policlinico

    Modena, Emilia-Romagna, 41124

  • Ospedale Sacro Cuore Don Calabria

    Negrar, Veneto, 37024

  • A.O.U. Maggiore della Carità

    Novara, 28100

  • Azienda Ospedale Università Padova - Dipartimento Salute della Donna e del Bambino - INCIPIT - PIN

    Padova, Veneto, 35128

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    Pavia, 27100

  • La Sapienza-Università di Roma-Policlinico Umberto I

    Roma, 00161

  • Fondazione Policlinico Universitario A Gemelli

    Roma, 00168

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, Lazio, 00152

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089

  • Ospedale Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo (FG), Apulia, 71013

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino, 10128

Other trials in Italy

Germany12 sites

  • Universitätsklinikum der RWTH Aachen

    Aachen, North Rhine-Westphalia, 52074

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353

  • Gastroenterologische Facharztpraxis am Mexikoplatz

    Berlin-Zehlendorf, 14163

  • Sana Klinikum Biberach

    Biberach an der Riss, 88400

  • Uniklinik Köln

    Cologne, 50937

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590

  • Asklepios Westklinikum Hamburg Ggmbh

    Hamburg, 22559

  • Universitätsklinikum Jena

    Jena, Thuringia, 07747

  • Universitatsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein, 24105

  • Klinikum rechts der Isa der Technischen Universitaet Muenchen

    Munich, 81675

  • Gastro Campus Research GbR

    Münster, North Rhine-Westphalia, 48159

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Romania11 sites

  • Dr.Carol Davila Emergency University Central Military Hospital

    Bucharest, 010825

  • Sana Monitoring SRL

    Bucharest, 011025

  • Colentina Clinical Hospital

    Bucharest, 020125

  • Prof. Dr. Matei Bals Institute of Infectious Diseases

    Bucharest, 021105

  • Fundeni Clinical Institute

    Bucharest, 022328

  • Centrul Medical Hifu Terramed Conformal S.R.L.

    Bucharest, 031864

  • Cluj-Napoca Emergency Clinical County Hospital

    Cluj-Napoca, Cluj, 400006

  • Affidea Romania SRL

    Constanța, RO-900591

  • Gastromedica SRL

    Iași, 700506

  • Dr. Tirnaveanu Amelita Private Practice

    Oradea, 410066

  • Dr. Goldis Gastroenterology Center SRL

    Timișoara, 300002

Other trials in Romania

United Kingdom9 sites

  • Aberdeen Royal Infirmary - PPDS

    Aberdeen, AB25 2ZN

  • Western General Hospital Edinburgh - PPDS

    Edinburh, EH4 2XU

  • Fairfield General Hospital - PPDS

    Lancashire, Bury, BL9 7TD

  • Pennine Acute Hospitals Trust

    Lancashire, Bury, BL9 7TD

  • Whipps Cross University Hospital

    London, London, City of, E11 1NR

  • Royal Gwent Hospital - PPDS

    Newport, NP20 2UB

  • North Tyneside General Hospital

    North Shields, Northumberland, NE29 8NH

  • Royal Shrewsbury Hospital

    Shrewsbury, Shropshire, SY3 8XQ

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Croatia8 sites

  • Opca bolnica Bjelovar

    Bjelovar, 43000

  • Opca Bolnica Karlovac

    Karlovac, Karlovacka Županija, 47000

  • Clinical Hospital Centre Osijek

    Osijek, 31000

  • University Hospital Centre Split

    Split, 21000

  • General Hospital Virovitica

    Virovitica, 33000

  • General County Hospital Vukovar and Croatian Veterans Hospital

    Vukovar, 32000

  • General Hospital Zadar

    Zadar, 23 000

  • University Hospital Center Zagreb

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Australia7 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • St Vincents Hospital Melbourne - PPDS

    Fitzroy, Victoria, 3065

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Mater Hospital Brisbane

    South Brisbane, Queensland, 4101

Other trials in Australia

Austria7 sites

  • LKH-Universitätsklinikum Klinikum Graz

    Graz, Styria, 8036

  • Klinikum Klagenfurt Am Woerthersee

    Klagenfurt, 9020

  • Salzburger Landeskliniken

    Salzburg, 5020

  • Universitätsklinikum St. Pölten

    Sankt Pölten, 3100

  • A.ö. Krankenhaus der Barmherzigen Brüder

    Sankt Veit an der Glan, Carinthia, 9300

  • Medizinische Universitat Wien (Medical University of Vienna)

    Vienna, 1090

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

Czechia6 sites

  • Hepato-Gastroenterologie HK, s. r. o.

    Hradec Králové, Hradec Králové Region, 500 12

  • PreventaMed s.r.o.

    Olomouc, Olomouc Region, 779 00

  • Institut Klinicke A Experimentalni Mediciny

    Prague, 140 21

  • ISCARE I.V.F. a.s.

    Prague, 170 04

  • Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

    Ústí nad Labem, 401 13

  • Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice

    Ústí nad Orlicí, 562 18

Other trials in Czechia

Israel6 sites

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah Medical Center - PPDS

    Jerusalem, 91120

  • Galilee Medical Center

    Nahariya, 22100

  • Nazareth EMMS Hospital

    Nazareth, 16100

  • Tel Aviv Sourasky Medical Center PPDS

    Tel Aviv, 6423906

  • Baruch Padeh Poriya Medical Center

    Tiberias, 15208

Other trials in Israel

Netherlands5 sites

  • NWZ, location Alkmaar

    Alkmaar, North Holland, 1815 JD

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • Academisch Medisch Centrum Amsterdam

    Amsterdam, 1105 AZ

  • Leids Universitair Medisch Centrum

    Leiden, South Holland, 2333 ZA

  • ETZ-Elisabeth

    Tilburg, North Brabant, 5022 GC

Other trials in Netherlands

Serbia4 sites

  • Clinical Hospital Center ''Bezanijska Kosa''

    Belgrade, 11080

  • University Clinical Center Kragujevac

    Kragujevac, Šumadijski Okrug, 34000

  • University Clinical Center Nis

    Niš, 18000

  • General Hospital Vrsac

    Vršac, 26300

Other trials in Serbia

Brazil3 sites

  • Instituto Goiano de Gastroenterologia E Endoscopia Digestiva Ltda

    Goiânia, Goiás, 74535-170

  • Hospital Da Cidade de Passo Fundo

    Passo Fundo, Rio Grande do Sul, 99010-260

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    Santo André, São Paulo, 09190-510

Other trials in Brazil

Lithuania3 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, LT-50009

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, LT- 08661

  • Vilnius City Clinical Hospital

    Vilnius, LT-10207

Other trials in Lithuania

South Africa3 sites

  • Dr JP Wright

    Claremont, Western Cape, 7708

  • CLINRESCO, ARWYP Medical Suites

    Johannesburg, Gauteng, 1619

  • Dr. J Breedt

    Pretoria, Gauteng, 0002

Other trials in South Africa

About this study

Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of participant-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

Being tested
Ontamalimab, Placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • OntamalimabDrug

    Also called PF-00547659, SHP647

    Participants will receive 1 mL of SHP647 sterile aqueous buffered solution at an appropriate concentration to provide the intended dose of drug (25 or 75 mg).

  • PlaceboOther

    Participants will receive 1 mL of sterile aqueous buffered solution.

Study groups in NCT03259334
Study groupRoleWhat they receive
Ontamalimab 25 mgExperimentalParticipants will receive 25 milligrams (mg) of ontamalimab (SHP647) subcutaneous (SC) injection using a prefilled syringe (PFS) on Week 0, Week 4 and Week 8.
Receives: Drug: Ontamalimab
Ontamalimab 75 mgExperimentalParticipants will receive 75 mg of ontamalimab (SHP647) SC injection using PFS on Week 0, Week 4 and Week 8.
Receives: Drug: Ontamalimab
PlaceboPlacebo comparatorParticipants will receive placebo matched to ontamalimab (SHP647) SC injection using PFS on Week 0, Week 4 and Week 8.
Receives: Other: Placebo

What is being measured

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

  1. Number of Participants With Remission at Week 12

    Remission was defined as a composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline, rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excluded friability). The composite score was a recommended measure consisted of the Mayo score without the physician global assessment (PGA) sub-score and ranged from 0 to 9 points. The Mayo score was a measure of Ulcerative Colitis (UC) disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease. The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).

    Measured: At Week 12

Secondary outcomes (23)

  1. Number of Participants With Endoscopic Remission at Week 12

    Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excluded friability). The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease.

    Measured: At Week 12

  2. Number of Participants With Clinical Remission at Week 12

    Clinical remission was defined by stool frequency (SF) sub-score of 0 or 1 with at least a 1-point change from baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. Rectal bleeding is assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency is assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.

    Measured: At Week 12

  3. Number of Participants With Clinical Response Based on Composite Score at Week 12

    Clinical response based on composite score was defined as a decrease from baseline in the composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub-score for rectal bleeding greater than or equal to (>=) 1 point or a sub-score for rectal bleeding less than or equal to (<=) 1. The composite score was a recommended measure derived from the Mayo score without the PGA sub-score and ranged from 0 to 9 points. The Mayo score was a measure of UC disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).

    Measured: At Week 12

  4. Number of Participants With Mucosal Healing Based on Endoscopic and Histological Assessment Using the Geboes Score Grading System at Week 12

    Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excluded friability) and centrally read Geboes score of <=2. The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system was a validated score for evaluating histologic disease activity in UC as follows: Grade 0 equal to (=) structural and architectural changes; Grade 1 = chronic inflammatory infiltrate; Grade 2 = lamina propria neutrophils and eosinophils; Grade 3 = neutrophils in the epithelium; Grade 4 = crypt destruction; Grade 5 = erosions or ulceration. A higher Geboes score indicating more severe disease.

    Measured: At Week 12

  5. Number of Participants With Remission Based on Total Mayo Score at Week 12

    Remission was defined as a total Mayo score of <=2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excluded friability], and PGA) exceeding 1. The Total Mayo score ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).

    Measured: At Week 12

  6. Number of Participants With Clinical Response Based on Total Mayo Score at Week 12

    Clinical response (Mayo) was defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding >=1 point or an absolute sub-score for rectal bleeding <=1. The Total Mayo score ranged from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).

    Measured: At Week 12

  7. Number of Participants With Partial Mayo Score <=2 With no Individual Sub-score Greater Than (>) 1 at Weeks 4, 8, and 12

    The partial Mayo score ranged from 0 to 9 points and consisted of the following 3 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); PGA (0-3). The partial Mayo score did not include the endoscopy sub-score.

    Measured: At Weeks 4, 8, and 12

  8. Number of Participants With Clinical Remission With Stool Frequency Sub-scores of 0 or 1 and Rectal Bleeding Sub-score of 0 at Weeks 4 and 8

    Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline in stool frequency sub-score, and a rectal bleeding sub-score of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease

    Measured: At Weeks 4 and 8

  9. Number of Participants With Endoscopic Remission With Sub-score of 0 at Week 12

    Endoscopic remission was defined by centrally read endoscopic sub-score 0 (modified, excluded friability). The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease.

    Measured: At Week 12

  10. Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Sub-scores of 0 at Weeks 4, 8, and 12

    Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.

    Measured: At Weeks 4, 8, and 12

  11. Number of Participants With Deep Remission at Week 12

    Deep remission was defined as both endoscopic and rectal bleeding sub-scores of 0, and stool frequency sub-score <=1 and a centrally read Geboes score of <=2. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease. The composite score was a recommended measure consisted of the Mayo score without the PGA sub-score and ranged from 0 to 9 points. Geboes score grading system was a validated score for evaluating histologic disease activity in UC as follows: Grade 0 = structural and architectural changes; Grade 1 = chronic inflammatory infiltrate; Grade 2 = lamina propria neutrophils and eosinophils; Grade 3 = neutrophils in the epithelium; Grade 4 = crypt destruction; Grade 5 = erosions or ulceration. A higher Geboes score indicating more severe disease.

    Measured: At Week 12

  12. Change From Baseline in Average Worst Abdominal Pain Score Based on Patient Reported Outcome-ulcerative Colitis (PRO-UC) Daily e-Diary at Week 12

    PRO-UC daily e-diary data was collected using a daily e-diary during the treatment period. Collection of the daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data of abdominal pain worst severity, as experienced over the previous 24 hours, in the e-diary. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or non-consecutive) of the last 10 days prior to scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Abdominal pain's worst severity assessment was based on an 11-point numerical rating scale with 0 anchor at "No pain" and 10 at "Worst Imaginable Pain" as experienced over the previous 24 hours, in e-diary. Higher scores indicating more severe pain.

    Measured: Baseline, Week 12

  13. Change From Baseline in Diarrhea (Average Loose Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12

    PRO-UC daily e-diary data was collected using a daily e-diary during the treatment period. Collection of the daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for number of loose bowel movement, as experienced over the previous 24 hours, in the e-diary. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number of loose bowel movement ranged from 0-27. Higher scores indicating more frequent bowel movements.

    Measured: Baseline, Week 12

  14. Change From Baseline in Average Bowel Movements With Urgency Score Based on PRO-UC Daily e-Diary at Week 12

    PRO-UC daily e-diary data was collected using a daily e-diary during the treatment period. Collection of the daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for number of bowel movement with urgency, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements urgency ranged from 0 to 27. Higher scores indicating more frequent bowel movements.

    Measured: Baseline, Week 12

  15. Change From Baseline in Absolute Stool Frequency (Average Number of Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12

    PRO-UC daily e-diary data was collected using a daily e-diary during the treatment period. Collection of the daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for average number of bowel movements, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements ranged from 0 to 27. Higher scores indicating more frequent bowel movements.

    Measured: Baseline, Week 12

  16. Change From Baseline in Absolute Rectal Bleeding (Average Number Bowel Movements With Blood) Score Based on PRO-UC Daily e-Diary at Week 12

    PRO-UC daily e-diary data was collected using a daily e-diary during the treatment period. Collection of the daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for average number of bowel movements with blood, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements with blood ranged from 0 to 27. Higher scores indicating more frequent bowel movements.

    Measured: Baseline, Week 12

  17. Change From Baseline in Total Sign/Symptom Score Based on PRO-UC Daily e-Diary at Week 12

    Total sign/symptom score was the average of the average scores of worst abdominal pain over the past 24 hours and the conversion scale values for number of bowel movements blood, number of bowel movements with urgency, number of bowel movements and number of loose bowel movements, with scale ranged of 0-10, with higher scores indicating higher severity.

    Measured: Baseline, Week 12

  18. Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12

    IBDQ was a psychometrically validated participant-reported outcome (PRO) instrument for measuring the disease-specific health-related quality of life (HRQL) in participants with inflammatory bowel disease, including UC. The IBDQ consisted of 32 items, which were grouped into 4 domains: bowel function, emotional status, systemic symptoms, and social function The 4 domains were scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. Higher scores indicating a better quality of life.

    Measured: Baseline, Weeks 8 and 12

  19. Change From Baseline in IBDQ Total Scores at Weeks 8 and 12

    IBDQ was a psychometrically validated PRO instrument for measuring the disease-specific HRQL in participants with inflammatory bowel disease, included UC. The IBDQ consisted of 32 items, which were grouped into 4 domains: bowel function, emotional status, systemic symptoms, and social function. The 4 domains were scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicating better HRQL. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points was considered to indicate a clinically meaningful improvement.

    Measured: Baseline, Weeks 8 and 12

  20. Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores) at Week 12

    SF-36 was a generic quality-of-life instrument that had been widely used to assess health-related quality of life (HRQL) of participants). SF-36 consisted of 36 items that were aggregated into 8 multi-item scales (physical functioning [1=yes, limited a lot to 3=no, not limited at all], role-physical [1=all of the time to 5=none of the time], bodily pain [1=very severe to 6=none], general health [1=poor to 5=excellent], vitality [1=none of the time to 5=all of the time], social functioning [1=all of the time: to 5=none of the time], role emotional [1=all of the time to 5=none of the time] and mental health [1=all of the time to 5=none of the time]). Four domains comprised physical component summary (PCS) score (physical functioning, role-physical, bodily pain, general health) and remaining 4 domains comprised mental component summary (MCS) score (vitality, social functioning, role-emotional, mental health). The scores ranged from 0 to 100. Higher scores indicating better HRQL.

    Measured: Baseline, Week 12

  21. Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12

    SF-36 was a generic quality-of-life instrument that had been widely used to assess HRQL of participants. The SF-36 consisted of 36 items that were aggregated into 8 multi-item scales (physical functioning [1=yes, limited a lot to 3=no, not limited at all], role-physical [1=all of the time to 5=none of the time], bodily pain [1=very severe to 6=none], general health [1=poor to 5=excellent], vitality [1=none of the time to 5=all of the time], social functioning [1=all of the time: to 5=none of the time], role emotional [1=all of the time to 5=none of the time] and mental health [1=all of the time to 5=none of the time]), with scores ranged from 0 to 100. Higher scores indicating better HRQL.

    Measured: Baseline, Week 12

  22. Number of Participants Based on In-patient Hospitalization

    Number of participants based on inpatient hospitalization due to all-cause hospitalization, gastrointestinal related, other illness/problem, and who had undergone gastrointestinal related procedures during the entire study period was reported.

    Measured: Baseline up to Week 12

  23. Median Duration of Total In-patient Days

    In-patient days were calculated as Date of discharge - Date of admission + 1. Median duration of total inpatient days during the entire study period was reported.

    Measured: Baseline up to Week 12

Timeline

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

  1. First posted23 Aug 2017
  2. Study start9 Feb 2018
  3. Primary completion22 Jul 2020
  4. Study completion23 Oct 2020

Why it stopped: Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
380 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03259334
Sponsor's protocol ID
SHP647-301
Other IDs
2017-000599-27, 2017
Acronym
FIGARO UC 301
Status last verified
Jun 2021
First submitted
21 Aug 2017
Last updated
14 Jun 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ontamalimab in people with Ulcerative Colitis, run by Shire at 207 sites in 18 countries.

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

Who may be eligible to take part?

The sponsor lists 13 inclusion and 60 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 207 sites in United States, Poland, Russia, Japan, Italy and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Number of Participants With Remission at Week 12 (time frame: At Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03259334.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.

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