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

NCT ID: NCT03566823

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-17
• Study Completion Date: 2020-08-18

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

SHP647; PF-00547659

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:

a. 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

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

Arizona Digestive Health Mesa - East

Mesa, Arizona, United States

Elite Clinical Studies - Phoenix - Clinedge - PPDS

Phoenix, Arizona, United States

Advanced Research Center

Anaheim, California, United States

Kindred Medical Institute for Clinical Trials, LLC

Corona, California, United States

Alliance Clinical Research-(Vestavia Hills)

Poway, California, United States

Care Access Research, San Pablo

San Pablo, California, United States

Renaissance Research Medical Group, INC

Cape Coral, Florida, United States

Gastro Florida

Clearwater, Florida, United States

Alliance Medical Research LLC

Coral Springs, Florida, United States

SIH Research

Kissimmee, Florida, United States

Hi Tech and Global Research, LLc

Miami, Florida, United States

Sanchez Clinical Research, Inc

Miami, Florida, United States

Crystal Biomedical Research

Miami Lakes, Florida, United States

Pharma Research International Inc

Naples, Florida, United States

Bayside Clinical Research - New Port Richey

New Port Richey, Florida, United States

Accel Research Sites - St. Petersburg - ERN - PPDS

Pinellas Park, Florida, United States

DBC Research

Tamarac, Florida, United States

Infinite Clinical Trials

Atlanta, Georgia, United States

Atlanta Center For Gastroenterology PC

Decatur, Georgia, United States

Atlanta Gastroenterology Specialists, PC

Suwanee, Georgia, United States

Loretto Hospital

Chicago, Illinois, United States

IL Gastroenterology Group

Gurnee, Illinois, United States

Cotton O'Neil Clinical Research Center

Topeka, Kansas, United States

Gastroenterology Associates of Hazard

Hazard, Kentucky, United States

CroNOLA, LLC.

Houma, Louisiana, United States

DelRicht Clinical Research, LLC - ClinEdge - PPDS

New Orleans, Louisiana, United States

Commonwealth Clinical Studies LLC

Brockton, Massachusetts, United States

Winchester Gastroenterology Associates

Winchester, Massachusetts, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Clinical Research Institute of Michigan

Chesterfield, Michigan, United States

National Clinical, LLC

Hamtramck, Michigan, United States

Gastroenterology Associates of Western Michigan, PLC

Wyoming, Michigan, United States

Mayo Clinic Health System - PPDS

Duluth, Minnesota, United States

Minnesota Gastroenterology PA

Plymouth, Minnesota, United States

Washington University in St. Louis

St Louis, Missouri, United States

Advanced Biomedical Research of America

Las Vegas, Nevada, United States

Encompass Care

North Las Vegas, Nevada, United States

NYU Langone Long Island Clinical Research Associates

Great Neck, New York, United States

Southtowns Gastroenterology, PLLC

Orchard Park, New York, United States

Penn State Hershey Medical Group

State College, Pennsylvania, United States

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

Garland, Texas, United States

Precision Research Institute, LLC

Houston, Texas, United States

Biopharma Informatic Inc.

Houston, Texas, United States

Southwest Clinical Trials

Houston, Texas, United States

BI Research Center

Houston, Texas, United States

Southern Star Research Institute LLC

San Antonio, Texas, United States

Mid Atlantic Health Specialists

Galax, Virginia, United States

Fundación Favaloro

Buenos Aires, , Argentina

Hospital Privado Centro Médico de Córdoba

Córdoba, , Argentina

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

AZ Groeninge

Kortrijk, West-Vlaanderen, Belgium

CHU Mouscron

Mouscron, , Belgium

Clinical Center Banja Luka

Banja Luka, , Bosnia and Herzegovina

Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD

Sofia, Sofia-Grad, Bulgaria

Multiprofile Hospital for Active Treatment Eurohospital

Plovdiv, , Bulgaria

Second Multiprofile Hospital for Active Treatment Sofia

Sofia, , Bulgaria

Diagnostic and Consulting Center Aleksandrovska EOOD

Sofia, , Bulgaria

University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

Sofia, , Bulgaria

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

Sofia, , Bulgaria

Medical Center Excelsior OOD - PPDS

Sofia, , Bulgaria

Medical Center Convex EOOD

Sofia, , Bulgaria

Diagnostic Consultative Centre Mladost - M OOD

Varna, , Bulgaria

Fundación Valle Del Lili

Cali, Valle del Cauca Department, Colombia

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

Cali, Valle del Cauca Department, Colombia

OÜ LV Venter

Pärnu, , Estonia

West Tallinn Central Hospital

Tallinn, , Estonia

Ippokrateio General Hospital of Athens

Athens, Attica, Greece

University General Hospital of Heraklion

Heraklion, , Greece

Iatriko Palaiou Falirou

Paliao Faliro, , Greece

University General Hospital of Patras

Pátrai, , Greece

Euromedica - PPDS

Thessaloniki, , Greece

Bekes Megyei Kozponti Korhaz

Békéscsaba, , Hungary

Magyar Honvédség Egészségügyi Központ

Budapest, , Hungary

Pannónia Magánorvosi Centrum Kft

Budapest, , Hungary

ENDOMEDIX Kft.

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Mohacsi Korhaz

Mohács, , Hungary

Tolna Megyei Balassa János Kórház

Szekszárd, , Hungary

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, , Hungary

St Vincent's University Hospital

Dublin, , Ireland

Sapporo Medical University Hospital

Sapporo, Hokkaidô, Japan

Medical Corporation Aoyama Clinic

Kobe, Hyôgo, Japan

Hyogo College of Medicine

Nishinomiya-shi, Hyôgo, Japan

Kunimoto Hospital

Asahikawa, , Japan

Chiinkai Dojima General & Gastroenterology Clinic

Osaka, , Japan

Kinshukai Infusion Clinic

Osaka, , Japan

Yodogawa Christian Hospital

Osaka, , Japan

Toho University Sakura Medical Center

Sakura, , Japan

Dokkyo Medical University Hospital

Shimotsuga-gun, , Japan

Nihonbashi Egawa Clinic

Tokyo, , Japan

Ishida Clinic of IBD and Gastroenterology

Ōita, Ôita, Japan

Al Zahraa University Hospital

Beirut, , Lebanon

Hammoud Hospital University Medical Center

Saida, , Lebanon

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

Zapopan, Jalisco, Mexico

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

Mexico City, Mexico City, Mexico

Clinica de Higado y Gastroenterologia Integral, S.C.

Cuernavaca, Morelos, Mexico

JM Research S.C

Cuernavaca, Morelos, Mexico

Accelerium, S. de R.L. de C.V.

Monterrey, Nuevo León, Mexico

Unidad de Atencion Medica e Investigacion en Salud

Mérida, Yucatán, Mexico

Centro de Investigacion Clinica Acelerada, S.C.

Distrito Federal, , Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, , Mexico

Dunedin Hospital

Dunedin, South Island, New Zealand

Wellington Hospital

Newtown, Wellington Region, New Zealand

Waikato Hospital

Hamilton, , New Zealand

Hospital da Luz

Lisbon, Lisbon District, Portugal

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

Guimarães, , Portugal

Centro Hospitalar do Algarve - Hospital de Portimao

Portimão, , Portugal

KM Management, spol. s r.o.

Nitra, , Slovakia

Gastro LM, s.r.o.

Prešov, , Slovakia

CHA Bundang Medical Center, CHA University

Seongnam, Gyeonggido, South Korea

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

Suwon, Gyeonggido, South Korea

Inje University Haeundae Paik Hospital

Busan, , South Korea

Pusan National University Hospital

Busan, , South Korea

Kyungpook National University Hospital

Daegu, , South Korea

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Inje University Seoul Paik Hospital

Seoul, , South Korea

Yonsei University Wonju Severance Christian Hospital

Wonju-si, Gangwon-do, , South Korea

C.H. Regional Reina Sofia - PPDS

Córdoba, Córdoba, Spain

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain

Hospital Universitario La Paz - PPDS

Madrid, Madrid, Communidad Delaware, Spain

CHUVI - H.U. Alvaro Cunqueiro

Vigo, Pontevedra, Spain

Centro Medico Teknon - Grupo Quironsalud

Barcelona, , Spain

Hospital Universitario Juan Ramon Jimenez

Huelva, , Spain

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, , Spain

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, , Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, , Turkey (Türkiye)

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

Chernivtsi, Chernivtsi Oblast, Ukraine

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

Kharkiv, Kharkivs’ka Oblast’, Ukraine

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

Kyiv, Kyïv, Ukraine

LLC Medical Center Family Medicine Clinic

Dnipro, , Ukraine

Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital

Kharkiv, , Ukraine

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

Kherson, , Ukraine

Medical Center of LLC Medical Clinic Blagomed

Kyiv, , Ukraine

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

Kyiv, , Ukraine

Medical Center of LLC Medical Center Dopomoga-Plus

Kyiv, , Ukraine

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

Kyiv, , Ukraine

Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital

Lviv, , Ukraine

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

Vinnytsia, , Ukraine

MNPE City Hospital No. 6 of Zaporizhzhia City Council

Zaporizhzhia, , Ukraine

Countries

United States; Argentina; Belgium; Bosnia and Herzegovina; Bulgaria; Colombia; Estonia; Greece; Hungary; Ireland; Japan; Lebanon; Mexico; New Zealand; Portugal; Slovakia; South Korea; Spain; Turkey (Türkiye); Ukraine

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/5f6b5fe54db2bf003ab47918

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

Other Identifiers

SHP647-306

Identifier Type: -

Identifier Source: org_study_id