AzTrials
AzTrials

Crohn's DiseasePhase 3CARMEN CD 305NCT03559517

Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 305)

A Phase 3 study testing Ontamalimab in people with Crohn's Disease, run by Shire at 138 sites in 16 countries.

Terminated

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease. Read more about this study

Who is it for?
Ages 16 to 80 years
Conditions the study is for
Crohn's Disease
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
30 participants
Where
138 sitesin 16 countries
Study dates
29 Aug 2018to 8 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 must be between greater than or equal to (> =) 16 and less than or equal to (<=) 80 years of age; participants less than (<) 18 years of age must weigh >=40 kg and must have body mass index >=16.5 kilogram per meter square (kg/m^2)
  • Participants must have active moderate to severe ileal (terminal ileum), ileocolic, or colonic CD at baseline (Visit 2) as defined by:
  • CDAI score between 220 and 450 (inclusive) AND
  • Meeting the following subscores in the 2 item PRO:
  • Abdominal pain subscore >= 5 (average worst daily pain on the 11 point NRS) and abdominal pain subscore >= 2 (average daily pain on the 4-point abdominal pain variable of CDAI) over the 7 most recent days out of the 10 days before colonoscopy preparation (may or may not be contiguous) AND/OR ii. Average of the daily stool frequency subscore >=4 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days out of the 10 days before colonoscopy preparation (may or may not be contiguous) c. Presence of ulcerations that are characteristic to CD, as determined by a colonoscopy performed during screening, and as defined by the SES-CD >6 (SES CD >=4 for isolated ileitis) Note that the participant must be confirmed as meeting the CDAI score and PRO subscore requirements before a colonoscopy is done
  • Participants must have a documented diagnosis (endoscopic with histology) of CD for >=3 months before screening. Documented diagnosis is defined as:
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  • A biopsy report in which the description of the histological findings is consistent with the CD diagnosis AND
  • A report documenting disease duration based upon prior colonoscopy Note: If a biopsy report is not available in the source document at the time of screening, a biopsy must be performed during the screening colonoscopy and the histology report should be consistent with the CD diagnosis. If the histology description does not support the CD diagnosis at this time point, the participant should not be randomized
  • Participants must be willing and able to undergo a colonoscopy during screening after all other inclusion criteria have been met
  • Participants must have had an inadequate response to, or lost response to, or had an intolerance to at least 1 conventional treatment such as sulfasalazine or mesalamine (5-aminosalicylic acid [5-ASA]), glucocorticoids, or immunosuppressants (azathioprine [AZA], 6-mercaptopurine [6-MP] or methotrexate [MTX]) or anti-tumor necrosis factor (anti-TNF). Participants who have had an inadequate response to sulfasalazine or mesalamine should have also failed at least 1 other conventional treatment such as glucocorticoids
  • Participants receiving any treatment(s) for CD 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. Males and females of reproductive potential who are sexually active must agree to use appropriate contraception (ie, highly effective methods for female and medically appropriate methods for male study participants, for the duration of the study

Who cannot join

  • Participants with indeterminate colitis, microscopic colitis, nonsteroidal anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis, or clinical/histologic findings suggestive of UC
  • 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 presence of enterovesical (ie, between the bowel and urinary bladder) or enterovaginal fistulae
  • Participants with current symptomatic diverticulitis or diverticulosis
  • Participants with clinically significant obstructive colonic stricture, or who have a history of bowel surgery within 6 months before screening, or who are likely to require surgery for CD during the treatment period. Participants who have undergone previous colonic resection or ileocolectomy more than 6 months before screening must have at least 25 cm of colon remaining
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  • Participants with past medical history of multiple small bowel resections resulting in clinically significant short bowel syndrome
  • Participants requiring total parenteral nutrition
  • Participants with past medical history of bowel surgery resulting in an existing or current stoma. Participants who had a j-pouch are excluded as a j-pouch could result in a stoma
  • Participants have had prior treatment with ontamalimab (formerly PF-00547659; 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 any nonbiologic treatment with immunomodulatory properties (other than AZA, 6-MP, or MTX) or continuous antibiotics (>2 weeks) for the treatment of CD within 30 days before baseline (Visit 2)
  • Participants have received anti-TNF treatment within 60 days before baseline (Visit 2)
  • Participants have received any biologic with immunomodulatory properties (other than anti-TNFs) within 90 days before baseline (Visit 2)
  • Participants have ever received anti-integrin/adhesion molecule treatment (eg, natalizumab,vedolizumab, efalizumab, etrolizumab, or any other investigational anti-integrin/adhesion molecule)
  • Participants have received lymphocytes apheresis or selective monocyte granulocytes apheresis within 60 days before baseline (Visit 2)
  • Participants have received enteral nutrition treatment within 30 days before baseline (Visit 2)
  • Participants have received parenteral or rectal glucocorticoids or rectal 5-ASA within 14 days before screening colonoscopy
  • Participants have taken >20 milligram per day(mg/day) of prednisone, >9 mg/day of budesonide, or equivalent oral systemic corticosteroid dose within 14 days before baseline (Visit 2) or have taken >=40 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 6 weeks before baseline (Visit 2)
  • 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 screening (Visit 1)
  • Participants have received a live (attenuated) vaccine within 30 days before the baseline visit (Visit 2)
  • Participants with active enteric infections (positive stool culture and sensitivity), Clostridium difficile infection or pseudomembranous colitis (subjects with C. difficile infection at screening may be allowed retest 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 subjects to infections, or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks before the baseline visit (Visit 2)
  • Participants with abnormal chest x-ray or other imaging findings at screening (Visit 1), such as presence of active tuberculosis (TB), general infections, heart failure, or malignancy (A chest x-ray, computed tomography scan, etc, performed up to 12 weeks before study entry [screening, Visit 1] may be used if available; documentation of the official reading must be located and available in the source documentation)
  • 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 baseline (Visit 2) 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 TB 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 the IGRA 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-Guérin 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 TB, a positive test on repeat will exclude the participantParticipants 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 (Visit 1)must show no abnormalities suggestive of active TB infection as determined by a qualified medical specialist
  • 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 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 (Visit 1) or baseline (Visit 2), including, but not limited to, the following:
  • Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, GI [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 subject 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 (Visit 1)
  • History of significant cerebrovascular disease within 24 weeks before screening (Visit 1)
  • Participants who have had significant trauma or major surgery within 4 weeks before the screening (Visit 1), or with any major elective surgery scheduled to occur during the study.
  • Participant with evidence of cirrhosis with or without decompensation (ie, esophageal varices, hepatic encephalopathy, portal hypertension, ascites)
  • Participant with primary sclerosing cholangitis
  • Participant with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) Note: if a subject tests negative for HBsAg, but positive for HBcAb, the subject would be considered eligible if no presence of hepatitis B virus (HBV) DNA is confirmed by HBV DNA polymerase chain reaction (PCR) reflex testing performed in the central laboratory
  • Participant with chronic hepatitis C virus (HCV) (positive HCV antibody [HCVAb] and HCV RNA) Note: Participant who are HCVAb positive without evidence of HCV RNA 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])
  • Participant with any of the following abnormalities in hematology and/or serum chemistry profiles during screening (Visit 1) Note: Screening laboratory tests, if the results are considered by the investigator to be transient and inconsistent with the subject's clinical condition, may be repeated once during the screening period for confirmation results must be reviewed for eligibility prior to the screening colonoscopy procedure
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels >=3.0 × the upper limit of normal (ULN)
  • Total bilirubin level >=1.5 × ULN or >2.0 × ULN if the subject has a known documented history of Gilbert's syndrome
  • Hemoglobin level less than or equal to(<=80) gram per liter(g/L) (8.0 g/deciliter[dL])
  • Platelet count <=100× 10^9/L (100,000 cells/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 <2 × 10^9/L (2000 cells/mm^3)
  • Serum creatinine level >1.5 × ULN or estimated glomerular filtration rate <30 millilter per minute (mL/min)/173 meter square (m^2) based on the abbreviated Modification of Diet in RenalDisease Study Equation Note: if platelet count is <150,000 cells/mm3, a further evaluation should be performed to rule out cirrhosis, unless another etiology has already been identified
  • Participant 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
  • 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.
  • 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 medicinal marijuana (cannabis)
  • NOTE: The above Inclusion/Exclusion criteria are NOT exhaustive and other Inclusion/ Exclusion criteria as defined in the protocol may apply.

Trial locations and contacts

138 sites in 16 countries.

138 sites in 16 countries

Poland29 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 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

  • NZOZ All Medicus

    Katowice, 40-659

  • Med Gastr Sp.z.o.o Sp.k

    Lodz, 91-034

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338

  • Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny

    Lódz, Lódzkie, 90-302

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

    Lódz, Lódzkie, 90-647

  • Twoja Przychodnia - Centrum Medyczne Nowa Sol

    Nowa Sól, 67-100

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

    Poznan, 60-856

  • 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, 70-361

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

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Centrum Medyczne Warszawa - PRATIA - PPDS

    Warsaw, Masovian Voivodeship, 00-660

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

    Warsaw, Masovian Voivodeship, 02-781

  • Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED

    Warsaw, Masovian Voivodeship, 03-580

  • Miedzyleski Szpital Specjalistyczny w Warszawie

    Warsaw, Masovian Voivodeship, 04-749

  • Centrum Zdrowia M D M

    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

United States25 sites

  • Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS

    Baytown, Texas, 77521

  • HP Clinical Research

    Bountiful, Utah, 84010

  • New York Total Medical Care PC

    Brooklyn, New York, 11215

  • Consultants For Clinical Research Inc

    Cincinnati, Ohio, 45219

  • Consultants For Clinical Research Inc

    Cincinnati, Ohio, 45249

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80903

  • Asthma and Allergy Associates PC - CRN - PPDS

    Colorado Springs, Colorado, 80907

  • Northside Gastroenterology

    Cypress, Texas, 77429

  • 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

  • Advanced Clinical Research Network

    Miami, Florida, 33176

  • Laporte County Institute For Clinical Research

    Michigan City, Indiana, 46360

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Omega Research Consultants LLC - Clinedge - PPDS

    Orlando, Florida, 32810

  • Inland Empire Liver Foundation

    Rialto, California, 92377

  • East Coast Institute for Research, LLC

    Saint Augustine, Florida, 32086

  • Louisiana Research Center LLC

    Shreveport, Louisiana, 71103

  • Piedmont Healthcare

    Statesville, North Carolina, 28625

  • CATS Research Center - University of Arizona

    Tucson, Arizona, 85724

  • Advanced Gastroenterology-Union City

    Union City, Tennessee, 38261

  • Digestive Disease Associates

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Romania12 sites

  • Sana Monitoring SRL

    Bucharest, Bucharest, 011025

  • Dr.Carol Davila Emergency University Central Military Hospital

    Bucharest, 010825

  • 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

  • Emergency University Hospital

    Bucharest, 050098

  • 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

Germany10 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, North Rhine-Westphalia, 50937

  • Universitätsklinikum Frankfurt

    Frankfurt, 60596

  • Universitatsklinikum 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

Other trials in Germany

Italy10 sites

  • 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, 41100

  • Ospedale Sacro Cuore Don Calabria

    Negrar, Veneto, 37024

  • A.O.U. Maggiore della Carità

    Novara, 28100

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    Pavia, 27100

  • La Sapienza-Università di Roma-Policlinico Umberto I

    Roma, 00161

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089

  • Ospedale Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, 71013

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Japan10 sites

  • Hidaka Coloproctology Clinic

    Kurume-shi, 839-0809

  • Jikei University Hospital

    Minato-ku, Tokyo, 105-8471

  • 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

  • Sapporo Tokushukai Hospital

    Sapporo, Hokkaidô, 004-0041

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, 065-0033

  • Colo-Proctology Center Matsushima Clinic

    Yokohama, 220-0045

Other trials in Japan

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • St Vincents Hospital Melbourne - PPDS

    Melbourne, Victoria, 3065

  • Mater Hospital Brisbane

    South Brisbane, Queensland, 4101

Other trials in Australia

Russia6 sites

  • Rostov State Medical University

    Rostov-on-Don, 344091

  • St. Elizabeth Municipal Clinical Hospital

    Saint Petersburg, 195067

  • 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

  • SHI Regional Clinical Hospital

    Saratov, 410012

Other trials in Russia

Serbia5 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

  • Clinical Hospital Center Zemun

    Zemun

Other trials in Serbia

Austria4 sites

  • LKH-Universitätsklinikum Klinikum Graz

    Graz, Styria, 8036

  • Salzburger Landeskliniken

    Salzburg, 5020

  • Klinikum Wels-Grieskirchen GmbH

    Vienna, State of Vienna, A-1090

  • Medizinische Universitat Wien (Medical University of Vienna)

    Vienna, 1090

Other trials in Austria

Croatia4 sites

  • Opca bolnica Bjelovar

    Bjelovar, 43000

  • Clinical Hospital Centre Osijek

    Osijek, 31000

  • General Hospital Virovitica

    Virovitica, 33000

  • University Hospital Center Zagreb

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Israel4 sites

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah Medical Center - PPDS

    Jerusalem, 91120

  • Galilee Medical Center

    Nahariya, 22100

  • Baruch Padeh Poriya Medical Center

    Tiberias, 15208

Other trials in Israel

South Africa4 sites

  • Dr JP Wright

    Claremont, Western Cape, 7708

  • CLINRESCO, ARWYP Medical Suites

    Johannesburg, Gauteng, 1619

  • Dr. J Breedt

    Pretoria, Gauteng, 0084

  • Emmed Research

    Pretoria, Gauteng, 0084

Other trials in South Africa

United Kingdom4 sites

  • Aberdeen Royal Infirmary - PPDS

    Aberdeen, AB25 2ZN

  • Royal Gwent Hospital - PPDS

    Newport, NP20 2UB

  • North Tyneside General Hospital

    North Shields, Northumberland, NE29 8NH

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Netherlands3 sites

  • Academisch Medisch Centrum Amsterdam

    Amsterdam, 1105 AZ

  • NWZ, location Alkmaar

    Den Helder, North Holland, 1782 GZ

  • ETZ-Elisabeth

    Tilburg, North Brabant, 5022 GC

Other trials in Netherlands

Lithuania2 sites

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, LT- 08661

  • Vilnius City Clinical Hospital

    Vilnius, LT-10207

Other trials in Lithuania

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 Crohn's Disease (CARMEN CD 305)

The purpose of this study is to evaluate the efficacy and safety of ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.

Read the detailed description

27Mar2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.

Conditions
Crohn's Disease
Being tested
Ontamalimab, Placebo
Medical subject headings
Crohn Disease

What participants receive

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

  • OntamalimabBiological

    Also called PF-00547659, SHP647

    Subcutaneous injection of ontamalimab will be administered using a prefilled syringe.

  • PlaceboOther

    Subcutaneous injection of placebo matched with ontamalimab will be administered using a prefilled syringe.

Study groups in NCT03559517
Study groupRoleWhat they receive
Ontamalimab 25 mgExperimentalParticipants will receive 25 mg of ontamalimab subcutaneous injection using a prefilled syringe on Week 0/Day 1, Week 4, Week 8, and Week 12.
Receives: Biological: Ontamalimab
Ontamalimab 75 mgExperimentalParticipants will receive 75 mg of ontamalimab subcutaneous injection using a prefilled syringe on Week 0/Day 1, Week 4, Week 8, and Week 12.
Receives: Biological: Ontamalimab
PlaceboPlacebo comparatorParticipants will receive placebo matching with ontamalimab subcutaneous injection using a prefilled syringe on Week 0/Day 1, Week 4, Week 8, and Week 12.
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 Clinical Remission Based on 2-item Patient-reported Outcome (PRO) at Week 16

    Clinical remission was defined by 2-item PRO subs-cores of average worst daily abdominal pain less than or equal to (<=) 3 (based on 11 point numerical rating scale [NRS] ranging from 0 [no pain] to 10 [worst imaginable pain]); and average daily stool frequency <=2 of type 6/7 (very soft stools/liquid stools) as per the Bristol Stool Form Scale (BSFS) over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 16 or discontinuation before Week 16 were considered failures. Number of participants with clinical remission were reported.

    Measured: At Week 16

  2. Number of Participants With Endoscopic Response at Week 16

    Endoscopic response was defined as a decrease in Simple Endoscopic Score for Crohn's disease (SES-CD) of at least 25 percent (%) from baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 16 or who discontinued before Week 16 were considered failures. Number of participants with endoscopic response were reported.

    Measured: At Week 16

Secondary outcomes (16)

  1. Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 16

    Clinical remission was defined as a CDAI score of <150. CDAI assessed CD based on clinical signs/symptoms such as number of liquid stools, intensity of abdominal pain, general well-being (subjective), and presence of complications, use of antidiarrheal, presence of abdominal mass,. physical examination and hematocrit (objective). CDAI score is equal to sum of weighted scores for subjective and objective items which range from 0-149 points: asymptomatic remission, 150-220 points: mild to moderate active CD, 221-450 points: moderate to severe active CD, >451 points: severely active to fulminant disease. Higher score indicating more severity. Number of participants with clinical remission as measured by CDAI were reported.

    Measured: At Week 16

  2. Number of Participants With Enhanced Endoscopic Response at Week 16

    Enhanced endoscopic response was defined as a decrease in SES-CD by matching segments of at least 50% from baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 16 or who discontinued before Week 16 were considered non-responders. Number of participants with enhanced endoscopic response were reported.

    Measured: At Week 16

  3. Number of Participants With Clinical Remission Based on 2-item PRO With 4-point Scale for Abdominal Pain at Week 16

    Clinical remission was defined by 2-item PRO subs-cores of average daily abdominal pain <=1 (based on the 4 point scale, with scores ranging from 0 [none] to 3 [severe]) over the 7 most recent days and average daily stool frequency <=3 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 16 or who discontinued before Week 16 were considered failures. Number of participants with enhanced endoscopic response were reported.

    Measured: At Week 16

  4. Number of Participants With Clinical Response Based on 2-item PRO With 2 Criteria at Week 16

    Clinical response was measured by 2-item PRO and defined as meeting at least 1 of the following 2 criteria: 1)A decrease of greater than or equal to (>=) 30% and at least 2 points from baseline in the average daily worst abdominal pain over the 7 most recent days, with the average daily stool frequency of type 6/7 (very soft stools/liquid stools) either a) not worsening from baseline and/or b) average daily stool frequency <=2 of type 6/7 as per the BSFS over the 7 most recent days; 2)A decrease of >=30% from baseline in the average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days, with the average daily worst abdominal pain either a) not worsening from baseline and/or b) worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days. Participants with missing data at Week16 or who discontinued before Week 16 were considered failures. Number of participants with clinical response were reported.

    Measured: At Week 16

  5. Number of Participants With Clinical Remission Based on 2-Item PRO With Endoscopic Response at Week 16

    Clinical remission was defined by 2-item PRO subs-cores of average worst daily abdominal pain <=3 (based on 11 point NRS ranging from 0 [no pain] to 10 [worst imaginable pain]) over the 7 most recent days and average daily stool frequency <=2 of type 6/7 (very soft stools/liquid stools) as per BSFS ranging from type 1 (separate hard lumps-like stools) to type 7 (entirely liquid stools) over the 7 most recent days. Endoscopic response was defined as a decrease in SES CD of at least 25% from baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 16 or who discontinued before Week 16 were considered failures. Number of participants with clinical remission and endoscopic response were reported.

    Measured: At Week 16

  6. Number of Participants With Complete Endoscopic Healing at Week 16

    Clinical remission was defined by 2-item PRO subs-cores of average worst daily abdominal pain <=3 (based on 11 point NRS ranging from 0 [no pain] to 10 [worst imaginable pain]) over the 7 most recent days and average daily stool frequency <=2 of type 6/7 (very soft stools/liquid stools) as per BSFS ranging from type 1 (separate hard lumps-like stools) to type 7 (entirely liquid stools) over the 7 most recent days. Endoscopic response was defined as a decrease in SES CD of at least 25% from baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 16 or who discontinued before Week 16 were considered failures. Number of participants with complete endoscopic healing were reported.

    Measured: At Week 16

  7. Number of Participants With Clinical Response as Measured by CDAI-100 at Week 16

    Clinical response is measured by at least a 100-point reduction in the CDAI from baseline (CDAI-100 response). CDAI assesses CD based on clinical signs/symptoms such as number of liquid stools, intensity of abdominal pain, general well-being (subjective), and presence of complications, use of antidiarrheal, presence of abdominal mass, physical examination and hematocrit (objective). CDAI score is equal to sum of weighted scores for subjective and objective items which range from 0-149 points: asymptomatic remission, 150-220 points: mild to moderate active CD, 221-450 points: moderate to severe active CD, >451 points: severely active to fulminant disease. Higher score indicating more severity.

    Measured: At Week 16

  8. Number of Participants With Clinical Response as Measured by CDAI-70 at Week 16

    Clinical response is measured by at least a 70-point reduction in the CDAI from baseline (CDAI-70 response). CDAI assesses CD based on clinical signs/symptoms such as number of liquid stools, intensity of abdominal pain, general well-being (subjective), and presence of complications, use of antidiarrheal, presence of abdominal mass, physical examination and hematocrit (objective). CDAI score is equal to sum of weighted scores for subjective and objective items which range from 0-149 points: asymptomatic remission, 150-220 points: mild to moderate active CD, 221-450 points: moderate to severe active CD, >451 points: severely active to fulminant disease. Higher score indicating more severity.

    Measured: At Week 16

  9. Number of Participants With Clinical Remission Over Time

    Clinical remission is defined by 2-item PRO subs-cores of average worst daily abdominal pain (based on 11 point NRS ranging from 0 [no pain] to 10 [worst imaginable pain]); and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per BSFS over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid).

    Measured: Baseline up to Week 16

  10. Change From Baseline in Individual and Total Sign/Symptom Score Based on Participant Daily Electronic Diary (E-diary) Entries at Week 16

    CD clinical signs and symptoms includes total stool frequency, rectal bleeding frequency, rectal urgency frequency, nausea severity, vomiting frequency, and rectal incontinence frequency.

    Measured: Baseline and at Week 16

  11. Number of Participants With Endoscopic Healing at Week 16

    Endoscopic healing is measured by SES-CD <=4 and at least 2-point reduction versus baseline and no sub-score >1 in any individual variable. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease.

    Measured: At Week 16

  12. Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total (Absolute) Score at Weeks 8, 12 and 16

    The IBDQ is a psychometrically validated PRO instrument for measuring the disease-specific health-related quality of life (HRQL) in participants with IBD, including CD. The IBDQ consists of 32 items, which are grouped into 4 domains and scored as: bowel function (10 to 70), systemic symptoms (5 to 35), emotional status (12 to 84), and social function (5 to 35). The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better HRQL. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points is considered to indicate a clinically meaningful improvement.

    Measured: Baseline, Weeks 8, 12 and 16

  13. Change From Baseline in Short Form-36 Health Survey (SF-36) Scores at Week 16

    The SF-36, version 2 is a generic quality-of-life instrument that has been widely used to assess HRQL of participants. The SF-36 consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role - physical, bodily pain, general health, vitality, social functioning, role - emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.

    Measured: Baseline, Week 16

  14. Number of Participants Based on Incidence of All-cause Hospitalizations

    Incidence of all cause hospitalizations was planned to be assessed.

    Measured: Baseline up to Week 32

  15. Number of Participants Based on Total Inpatient Days

    Total inpatient days were planned to be assessed.

    Measured: Baseline up to Week 32

  16. Number of Participants Based on Incidence of CD-related Surgeries and Other Surgical Procedures

    Incidence of CD-related surgeries and other surgical procedures were planned to be recorded.

    Measured: Baseline up to Week 32

Timeline

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

  1. First posted18 Jun 2018
  2. Study start29 Aug 2018
  3. Primary completion7 Jul 2020
  4. Study completion8 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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03559517
Sponsor's protocol ID
SHP647-305
Acronym
CARMEN CD 305
Status last verified
Apr 2021
First submitted
9 May 2018
Last updated
29 Apr 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Vermeire S, Danese S, Sandborn WJ, Schreiber S, Hanauer S, D'Haens G, Nagy P, Thakur M, Bliss C, Cataldi F, Goetsch M, Gorelick KJ, Reinisch W. Efficacy and Safety of the Anti-mucosal Addressin Cell Adhesion Molecule-1 Antibody Ontamalimab in Patients with Moderate-to-Severe Ulcerative Colitis or Crohn's Disease. J Crohns Colitis. 2024 May 31;18(5):708-719. doi: 10.1093/ecco-jcc/jjad199.

    PubMed 38096402

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ontamalimab in people with Crohn's Disease, run by Shire at 138 sites in 16 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 12 inclusion and 53 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 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in Poland, United States, Romania, Germany, Italy and 11 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 29 Apr 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 Clinical Remission Based on 2-item Patient-reported Outcome (PRO) at Week 16 (time frame: At Week 16). The study lists 2 primary outcomes in all. 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 NCT03559517, which also lists 1 linked publication.

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 29 Apr 2021.

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