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

NCT ID: NCT03559517

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-29
• Study Completion Date: 2020-10-08

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ontamalimab 25 mg

Participants will receive 25 mg of ontamalimab subcutaneous injection using a prefilled syringe on Week 0/Day 1, Week 4, Week 8, and Week 12.

Group Type: EXPERIMENTAL

Ontamalimab

Intervention Type: BIOLOGICAL

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

Ontamalimab 75 mg

Participants will receive 75 mg of ontamalimab subcutaneous injection using a prefilled syringe on Week 0/Day 1, Week 4, Week 8, and Week 12.

Group Type: EXPERIMENTAL

Ontamalimab

Intervention Type: BIOLOGICAL

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

Placebo

Participants will receive placebo matching with ontamalimab subcutaneous injection using a prefilled syringe on Week 0/Day 1, Week 4, Week 8, and Week 12.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Ontamalimab

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

Intervention Type: BIOLOGICAL

Placebo

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

Intervention Type: OTHER

Other Intervention Names

PF-00547659; SHP647

Eligibility Criteria

Inclusion Criteria

• 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:

1. CDAI score between 220 and 450 (inclusive) AND

2. Meeting the following subscores in the 2 item PRO:

i. 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:

1. A biopsy report in which the description of the histological findings is consistent with the CD diagnosis AND

2. 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 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

Exclusion Criteria

• 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
• 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:

1. 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

2. 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

3. 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:

1. 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

2. 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)

3. Presence of acute coronary syndrome (eg, acute myocardial infarction, unstable angina pectoris) within 24 weeks before screening (Visit 1)

4. 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

1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels >=3.0 × the upper limit of normal (ULN)

2. Total bilirubin level >=1.5 × ULN or >2.0 × ULN if the subject has a known documented history of Gilbert's syndrome

3. Hemoglobin level less than or equal to(<=80) gram per liter(g/L) (8.0 g/deciliter[dL])

4. Platelet count <=100× 10^9/L (100,000 cells/mm^3) or >=1000 × 10^9/L (1,000,000 cells/mm^3)*

5. White blood cell count <=3.5 × 10^9/L (3500 cells/mm^3)

6. Absolute neutrophil count <2 × 10^9/L (2000 cells/mm^3)

7. 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)

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Shire

Locations

CATS Research Center - University of Arizona

Tucson, Arizona, United States

Atria Clinical Research - Clinedge - PPDS

Little Rock, Arkansas, United States

OM Research LLC - Lancaster - ClinEdge - PPDS

Lancaster, California, United States

Inland Empire Liver Foundation

Rialto, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Asthma and Allergy Associates PC - CRN - PPDS

Colorado Springs, Colorado, United States

Advanced Clinical Research Network

Miami, Florida, United States

Gastroenterology Group of Naples

Naples, Florida, United States

Omega Research Consultants LLC - Clinedge - PPDS

Orlando, Florida, United States

East Coast Institute for Research, LLC

Saint Augustine, Florida, United States

Laporte County Institute For Clinical Research

Michigan City, Indiana, United States

Clinical Trials of SWLA LLC

Lake Charles, Louisiana, United States

Louisiana Research Center LLC

Shreveport, Louisiana, United States

New York Total Medical Care PC

Brooklyn, New York, United States

Piedmont Healthcare

Statesville, North Carolina, United States

Consultants For Clinical Research Inc

Cincinnati, Ohio, United States

Consultants For Clinical Research Inc

Cincinnati, Ohio, United States

Consultants For Clinical Research Inc

Fairfield, Ohio, United States

Digestive Disease Associates

Wyomissing, Pennsylvania, United States

Gastro One

Germantown, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Advanced Gastroenterology-Union City

Union City, Tennessee, United States

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

Baytown, Texas, United States

Northside Gastroenterology

Cypress, Texas, United States

HP Clinical Research

Bountiful, Utah, United States

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Mater Hospital Brisbane

South Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

St Vincents Hospital Melbourne - PPDS

Melbourne, Victoria, Australia

LKH-Universitätsklinikum Klinikum Graz

Graz, Styria, Austria

Klinikum Wels-Grieskirchen GmbH

Vienna, Vienna, Austria

Salzburger Landeskliniken

Salzburg, , Austria

Medizinische Universitat Wien (Medical University of Vienna)

Vienna, , Austria

University Hospital Center Zagreb

Zagreb, City of Zagreb, Croatia

Opca bolnica Bjelovar

Bjelovar, , Croatia

Clinical Hospital Centre Osijek

Osijek, , Croatia

General Hospital Virovitica

Virovitica, , Croatia

Universitätsklinikum der RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

Uniklinik Köln

Cologne, North Rhine-Westphalia, Germany

Gastro Campus Research GbR

Münster, North Rhine-Westphalia, Germany

Universitatsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Universitatsklinikum Jena

Jena, Thuringia, Germany

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Gastroenterologische Facharztpraxis am Mexikoplatz

Berlin-Zehlendorf, , Germany

Sana Klinikum Biberach

Biberach an der Riss, , Germany

Universitätsklinikum Frankfurt

Frankfurt, , Germany

Klinikum rechts der Isa der Technischen Universitaet Muenchen

Munich, , Germany

Shaare Zedek Medical Center

Jerusalem, , Israel

Hadassah Medical Center - PPDS

Jerusalem, , Israel

Galilee Medical Center

Nahariya, , Israel

Baruch Padeh Poriya Medical Center

Tiberias, , Israel

Azienda Ospedaliera Mater Domini Di Catanzaro

Catanzaro, Calabria, Italy

Azienda Ospedaliero Universitaria Di Modena Policlinico

Modena, Emilia-Romagna, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, Italy

Ospedale Sacro Cuore Don Calabria

Negrar, Veneto, Italy

A.O.U. Maggiore della Carità

Novara, , Italy

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, , Italy

La Sapienza-Università di Roma-Policlinico Umberto I

Roma, , Italy

Istituto Clinico Humanitas

Rozzano (MI), , Italy

Ospedale Casa Sollievo Della Sofferenza IRCCS

San Giovanni Rotondo, , Italy

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, , Italy

Sapporo Tokushukai Hospital

Sapporo, Hokkaidô, Japan

Jikei University Hospital

Minato-ku, Tokyo, Japan

Ome Municipal General Hospital

Ōme, Tokyo, Japan

Hidaka Coloproctology Clinic

Kurume-shi, , Japan

Aichi Medical University Hospital

Nagakute, , Japan

Nishinomiya Municipal Central Hospital

Nishinomiya, , Japan

Onomichi General Hospital

Onomichi, , Japan

Shiga University of Medical Science Hospital

Ōtsu, , Japan

Sapporo Higashi Tokushukai Hospital

Sapporo, , Japan

Colo-Proctology Center Matsushima Clinic

Yokohama, , Japan

Vilnius University Hospital Santaros Klinikos

Vilnius, , Lithuania

Vilnius City Clinical Hospital

Vilnius, , Lithuania

ETZ-Elisabeth

Tilburg, North Brabant, Netherlands

NWZ, location Alkmaar

Den Helder, North Holland, Netherlands

Academisch Medisch Centrum Amsterdam

Amsterdam, , Netherlands

Vitamed Galaj i Cichomski sp.j.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

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

Torun, Kuyavian-Pomeranian Voivodeship, Poland

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

Włocławek, Kuyavian-Pomeranian Voivodeship, Poland

Melita Medical

Wroclaw, Lower Silesian Voivodeship, Poland

Lexmedica

Wroclaw, Lower Silesian Voivodeship, Poland

Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny

Lódz, Lódzkie, Poland

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

Lódz, Lódzkie, Poland

Centrum Medyczne Warszawa - PRATIA - PPDS

Warsaw, Masovian Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED

Warsaw, Masovian Voivodeship, Poland

Miedzyleski Szpital Specjalistyczny w Warszawie

Warsaw, Masovian Voivodeship, Poland

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Podlaskie Voivodeship, Poland

Endoskopia Sp. z o.o.

Sopot, Pomeranian Voivodeship, Poland

Twoja Przychodnia - Szczecińskie Centrum Medyczne

Szczecin, West Pomeranian Voivodeship, Poland

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

Bydgoszcz, , Poland

Centrum Medyczne Czestochowa - PRATIA - PPDS

Częstochowa, , Poland

Centrum Medyczne Gdynia - PRATIA - PPDS

Gdynia, , Poland

BioVirtus Centrum Medyczne

Józefów, , Poland

NZOZ All Medicus

Katowice, , Poland

Med Gastr Sp.z.o.o Sp.k

Lodz, , Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, , Poland

Twoja Przychodnia - Centrum Medyczne Nowa Sol

Nowa Sól, , Poland

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

Poznan, , Poland

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, , Poland

Sonomed Sp. z o.o.

Szczecin, , Poland

Centrum Zdrowia M D M

Warsaw, , Poland

Centralny Szpital Kliniczny MSW

Warsaw, , Poland

Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II

Zamość, , Poland

Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii

Gmina Końskie, Świętokrzyskie Voivodeship, Poland

Sana Monitoring SRL

Bucharest, București, Romania

Cluj-Napoca Emergency Clinical County Hospital

Cluj-Napoca, Cluj, Romania

Dr.Carol Davila Emergency University Central Military Hospital

Bucharest, , Romania

Colentina Clinical Hospital

Bucharest, , Romania

Prof. Dr. Matei Bals Institute of Infectious Diseases

Bucharest, , Romania

Fundeni Clinical Institute

Bucharest, , Romania

Centrul Medical Hifu Terramed Conformal S.R.L.

Bucharest, , Romania

Emergency University Hospital

Bucharest, , Romania

Affidea Romania SRL

Constanța, , Romania

Gastromedica SRL

Iași, , Romania

Dr. Tirnaveanu Amelita Private Practice

Oradea, , Romania

Dr. Goldis Gastroenterology Center SRL

Timișoara, , Romania

Rostov State Medical University

Rostov-on-Don, , Russia

St. Elizabeth Municipal Clinical Hospital

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

Medical University Reaviz

Samara, , Russia

Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city

Samara, , Russia

SHI Regional Clinical Hospital

Saratov, , Russia

Clinical Hospital Center ''Bezanijska Kosa''

Belgrade, , Serbia

University Clinical Center Nis

Niš, , Serbia

General Hospital Vrsac

Vršac, , Serbia

Clinical Hospital Center Zemun

Zemun, , Serbia

University Clinical Center Kragujevac

Kragujevac, Šumadijski Okrug, Serbia

CLINRESCO, ARWYP Medical Suites

Johannesburg, Gauteng, South Africa

Dr. J Breedt

Pretoria, Gauteng, South Africa

Emmed Research

Pretoria, Gauteng, South Africa

Dr JP Wright

Claremont, Western Cape, South Africa

North Tyneside General Hospital

North Shields, Northumberland, United Kingdom

Aberdeen Royal Infirmary - PPDS

Aberdeen, , United Kingdom

Royal Gwent Hospital - PPDS

Newport, , United Kingdom

New Cross Hospital

Wolverhampton, , United Kingdom

Countries

United States; Australia; Austria; Croatia; Germany; Israel; Italy; Japan; Lithuania; Netherlands; Poland; Romania; Russia; Serbia; South Africa; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 38096402 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.takeda.com/study-detail/5f6b5fe44db2bf003ab4788a

To obtain more information on the study, click here/on this link

Other Identifiers

SHP647-305

Identifier Type: -

Identifier Source: org_study_id