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AzTrials

Crohn's DiseasePhase 3CARMEN CD 306NCT03566823

Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)

A Phase 3 study testing Ontamalimab in people with Crohn's Disease, run by Shire at 145 sites in 20 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 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
34 participants
Where
145 sitesin 20 countries
Study dates
17 Jul 2018to 18 Aug 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 b. 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) c. Presence of acute coronary syndrome (eg, acute myocardial infarction, unstable angina pectoris) within 24 weeks before screening (Visit 1) d. 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

145 sites in 20 countries.

145 sites in 20 countries

United States48 sites

  • Advanced Research Center

    Anaheim, California, 92805

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Infinite Clinical Trials

    Atlanta, Georgia, 30349

  • Commonwealth Clinical Studies LLC

    Brockton, Massachusetts, 02302

  • Renaissance Research Medical Group, INC

    Cape Coral, Florida, 33991

  • Clinical Research Institute of Michigan

    Chesterfield, Michigan, 48047

  • Loretto Hospital

    Chicago, Illinois, 60644

  • Gastro Florida

    Clearwater, Florida, 33756

  • Alliance Medical Research LLC

    Coral Springs, Florida, 33071

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California, 92879

  • Atlanta Center For Gastroenterology PC

    Decatur, Georgia, 30033

  • Mayo Clinic Health System - PPDS

    Duluth, Minnesota, 55805

  • Mid Atlantic Health Specialists

    Galax, Virginia, 24333

  • Digestive Health Associates of Texas, P.A.dba DHAT Research Institute

    Garland, Texas, 75044

  • NYU Langone Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • IL Gastroenterology Group

    Gurnee, Illinois, 60031

  • National Clinical, LLC

    Hamtramck, Michigan, 48212

  • Gastroenterology Associates of Hazard

    Hazard, Kentucky, 41701

  • CroNOLA, LLC.

    Houma, Louisiana, 70360

  • Precision Research Institute, LLC

    Houston, Texas, 77039

  • Biopharma Informatic Inc.

    Houston, Texas, 77043

  • Southwest Clinical Trials

    Houston, Texas, 77074

  • BI Research Center

    Houston, Texas, 77084

  • SIH Research

    Kissimmee, Florida, 34741

  • Advanced Biomedical Research of America

    Las Vegas, Nevada, 89123

  • Arizona Digestive Health Mesa - East

    Mesa, Arizona, 85206

  • Hi Tech and Global Research, LLc

    Miami, Florida, 33135

  • Sanchez Clinical Research, Inc

    Miami, Florida, 33157

  • Crystal Biomedical Research

    Miami Lakes, Florida, 33065

  • Pharma Research International Inc

    Naples, Florida, 34110

  • DelRicht Clinical Research, LLC - ClinEdge - PPDS

    New Orleans, Louisiana, 70115

  • Bayside Clinical Research - New Port Richey

    New Port Richey, Florida, 34655

  • Encompass Care

    North Las Vegas, Nevada, 89086

  • Southtowns Gastroenterology, PLLC

    Orchard Park, New York, 14127

  • Elite Clinical Studies - Phoenix - Clinedge - PPDS

    Phoenix, Arizona, 85018

  • Accel Research Sites - St. Petersburg - ERN - PPDS

    Pinellas Park, Florida, 33781

  • Minnesota Gastroenterology PA

    Plymouth, Minnesota, 55446

  • Alliance Clinical Research-(Vestavia Hills)

    Poway, California, 92064

  • Southern Star Research Institute LLC

    San Antonio, Texas, 78229

  • Care Access Research, San Pablo

    San Pablo, California, 94806

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • Penn State Hershey Medical Group

    State College, Pennsylvania, 16803

  • Atlanta Gastroenterology Specialists, PC

    Suwanee, Georgia, 30024

  • DBC Research

    Tamarac, Florida, 33321

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Winchester Gastroenterology Associates

    Winchester, Massachusetts, 22601

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

  • Gastroenterology Associates of Western Michigan, PLC

    Wyoming, Michigan, 49519

Other trials in United States

Ukraine13 sites

  • Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"

    Chernivtsi, Chernivtsi Oblast, 58001

  • LLC Medical Center Family Medicine Clinic

    Dnipro, 49038

  • Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council

    Kharkiv, Kharkiv Oblast, 61037

  • Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital

    Kharkiv, 61058

  • Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh

    Kherson, 73000

  • Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital

    Kyiv, Kyïv, 04107

  • Medical Center of LLC Medical Clinic Blagomed

    Kyiv, 01023

  • Medical Center OK!Clinic+LLC International Institute of Clinical Research

    Kyiv, 02091

  • Medical Center of LLC Medical Center Dopomoga-Plus

    Kyiv, 02132

  • Communal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Hospital

    Kyiv, 04073

  • Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital

    Lviv, 79059

  • Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital No1"

    Vinnytsia, 21029

  • MNPE City Hospital No. 6 of Zaporizhzhia City Council

    Zaporizhzhya, 69035

Other trials in Ukraine

Japan11 sites

  • Kunimoto Hospital

    Asahikawa, 070-0061

  • Medical Corporation Aoyama Clinic

    Kobe, Hyôgo, 650-0015

  • Hyogo College of Medicine

    Nishinomiya-shi, Hyôgo, 663-8501

  • Ishida Clinic of IBD and Gastroenterology

    Ōita, Ôita, 870-0823

  • Chiinkai Dojima General & Gastroenterology Clinic

    Osaka, 530-0003

  • Kinshukai Infusion Clinic

    Osaka, 530-0011

  • Yodogawa Christian Hospital

    Osaka, 533-0024

  • Toho University Sakura Medical Center

    Sakura, 285-8741

  • Sapporo Medical University Hospital

    Sapporo, Hokkaidô, 060-8543

  • Dokkyo Medical University Hospital

    Shimotsuga-gun, 321-0293

  • Nihonbashi Egawa Clinic

    Tokyo, 103-0028

Other trials in Japan

South Korea11 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Pusan National University Hospital

    Busan, 49241

  • Kyungpook National University Hospital

    Daegu, 41944

  • Kyungpook National University Chilgok Hospital

    Daegu, 702-210

  • Gachon University Gil Medical Center

    Incheon, 21565

  • CHA Bundang Medical Center, CHA University

    Seongnam, Gyeonggido, 13496

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Inje University Seoul Paik Hospital

    Seoul, 04551

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, Gyeonggido, 16247

  • Yonsei University Wonju Severance Christian Hospital

    Wonju-si, Gangwon-do, 26426

Other trials in South Korea

Bulgaria9 sites

  • Multiprofile Hospital for Active Treatment Eurohospital

    Plovdiv, 4000

  • Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD

    Sofia, Sofia-Grad, 1784

  • Second Multiprofile Hospital for Active Treatment Sofia

    Sofia, 1202

  • Diagnostic and Consulting Center Aleksandrovska EOOD

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

    Sofia, 1527

  • Medical Center Excelsior OOD - PPDS

    Sofia, 1632

  • Medical Center Convex EOOD

    Sofia, 1680

  • Diagnostic Consultative Centre Mladost - M OOD

    Varna, 9000

Other trials in Bulgaria

Spain9 sites

  • Centro Medico Teknon - Grupo Quironsalud

    Barcelona, 8022

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, Córdoba, 14004

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, Madrid, 28942

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005

  • Hospital Universitario La Paz - PPDS

    Madrid, Madrid, Communidad Delaware, 28046

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, 41013

  • CHUVI - H.U. Alvaro Cunqueiro

    Vigo, Pontevedra, 36312

Other trials in Spain

Hungary8 sites

  • Bekes Megyei Kozponti Korhaz

    Békéscsaba, 5600

  • Magyar Honvédség Egészségügyi Központ

    Budapest, 1062

  • Pannónia Magánorvosi Centrum Kft

    Budapest, 1135

  • ENDOMEDIX Kft.

    Budapest, 1139

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Mohacsi Korhaz

    Mohács, 7700

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

  • Tolna Megyei Balassa János Kórház

    Szekszárd, 7100

Other trials in Hungary

Mexico8 sites

  • Clinica de Higado y Gastroenterologia Integral, S.C.

    Cuernavaca, Morelos, 62170

  • JM Research S.C

    Cuernavaca, Morelos, 62290

  • Centro de Investigacion Clinica Acelerada, S.C.

    Distrito Federal, 07020

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

    Durango, 34000

  • Unidad de Atencion Medica e Investigacion en Salud

    Mérida, Yucatán, 97000

  • Health Pharma Professional Research S.A de C.V.

    Mexico City, Mexico City, 03810

  • Accelerium, S. de R.L. de C.V.

    Monterrey, Nuevo León, 64000

  • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

    Zapopan, Jalisco, 45030

Other trials in Mexico

Greece5 sites

  • Ippokrateio General Hospital of Athens

    Athens, Attica, 11527

  • University General Hospital of Heraklion

    Heraklion, 71110

  • Iatriko Palaiou Falirou

    Paliao Faliro, 17562

  • University General Hospital of Patras

    Pátrai, 26504

  • Euromedica - PPDS

    Thessaloniki, 54645

Other trials in Greece

Belgium3 sites

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

  • AZ Groeninge

    Kortrijk, West-Vlaanderen, 8500

  • CHU Mouscron

    Mouscron, 7700

Other trials in Belgium

New Zealand3 sites

  • Dunedin Hospital

    Dunedin, South Island, 9016

  • Waikato Hospital

    Hamilton, 3240

  • Wellington Hospital

    Newtown, Wellington Region, 6021

Other trials in New Zealand

Portugal3 sites

  • Hospital Senhora da Oliveira - Guimaraes, E.P.E

    Guimarães, 4835-044

  • Hospital da Luz

    Lisbon, Lisbon District, 1500-650

  • Centro Hospitalar do Algarve - Hospital de Portimao

    Portimão, 8500-338

Other trials in Portugal

Argentina2 sites

  • Fundación Favaloro

    Buenos Aires, C1093AAS

  • Hospital Privado Centro Médico de Córdoba

    Córdoba

Other trials in Argentina

Colombia2 sites

  • Fundación Valle Del Lili

    Cali, Valle del Cauca Department, 760026

  • IPS Centro Médico Julián Coronel S.A.S. - PPDS

    Cali, Valle del Cauca Department, 760035

Other trials in Colombia

Estonia2 sites

  • OÜ LV Venter

    Pärnu, 80010

  • West Tallinn Central Hospital

    Tallinn, 10617

Other trials in Estonia

Lebanon2 sites

  • Al Zahraa University Hospital

    Beirut

  • Hammoud Hospital University Medical Center

    Saida

Other trials in Lebanon

Slovakia2 sites

  • KM Management, spol. s r.o.

    Nitra, 949 01

  • Gastro LM, s.r.o.

    Prešov, 080 01

Other trials in Slovakia

Turkey (Türkiye)2 sites

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    Istanbul, 34098

  • Mersin University Medical Faculty

    Mersin, 33169

Other trials in Turkey (Türkiye)

Bosnia and Herzegovina1 site

  • Clinical Center Banja Luka

    Banja Luka, 78000

Other trials in Bosnia and Herzegovina

Ireland1 site

  • St Vincent's University Hospital

    Dublin, 4

Other trials in Ireland

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 306)

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 SHP647, PF-00547659

    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 NCT03566823
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 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. 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 was 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 was 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 was 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: At Week 16

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

    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 was 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 posted25 Jun 2018
  2. Study start17 Jul 2018
  3. Primary completion18 Aug 2020
  4. Study completion18 Aug 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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03566823
Sponsor's protocol ID
SHP647-306
Acronym
CARMEN CD 306
Status last verified
Apr 2021
First submitted
9 May 2018
Last updated
11 May 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 145 sites in 20 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 50 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 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 145 sites in United States, Ukraine, Japan, South Korea, Bulgaria and 15 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 11 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 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 NCT03566823, 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 11 May 2021.

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