Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease
NCT ID: NCT02405442
Last Updated: 2019-04-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
187 participants
INTERVENTIONAL
2015-04-30
2016-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Andecaliximab 150 mg Every 2 Weeks
Double-Blind Phase: Participants will receive 1 single-use prefilled syringe (PFS) of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5, and 7. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for an additional 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks.
Andecaliximab
Andecaliximab administered via subcutaneous (SC) injection
Placebo
Placebo to match andecaliximab administered via SC injection
Andecaliximab 150 mg Weekly
Double-Blind Phase: Participants will receive 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for an additional 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks.
Andecaliximab
Andecaliximab administered via subcutaneous (SC) injection
Placebo
Placebo to match andecaliximab administered via SC injection
Andecaliximab 300 mg Weekly
Double-Blind Phase: Participants will receive 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for an additional 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks.
Andecaliximab
Andecaliximab administered via subcutaneous (SC) injection
Placebo
Double-Blind Phase: Participants will receive 2 single-use PFS of placebo coadministered weekly for 8 weeks. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks.
Andecaliximab
Andecaliximab administered via subcutaneous (SC) injection
Placebo
Placebo to match andecaliximab administered via SC injection
Interventions
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Andecaliximab
Andecaliximab administered via subcutaneous (SC) injection
Placebo
Placebo to match andecaliximab administered via SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Females of childbearing potential must have a negative pregnancy test at screening and baseline
* Documented diagnosis of Crohn's disease with a minimum disease duration of 6 months with involvement of the ileum and/or colon at a minimum
* Moderately to severely active Crohn's disease as defined by a Crohn's Disease Activity Index (CDAI) total score between 220-450 (inclusive) AND with evidence of active disease as measured by ileocolonoscopy
* Within the previous 5 years, demonstrated an inadequate clinical response or intolerance of at least one of the following agents:
* Corticosteroids
* Immunomodulators
* Tumor necrosis factor-alpha (TNFα) antagonists
* Vedolizumab
* May be receiving the following drugs:
* Oral 5-aminosalicylate (5-ASA)
* Oral corticosteroid therapy
* Antidiarrheals for chronic diarrhea
* Azathioprine or 6-mercaptopurine (6-MP) or methotrexate
* Antibiotics for the treatment of Crohn's disease
* Able to comply with the dosing instructions for study drug and able to comply with the study visits and requirements
Exclusion Criteria
* Extensive colonic resection (subtotal or total colectomy) or history of \> 2 small bowel resections
* Ileostomy, colostomy, or symptomatic stenosis of the intestine
* Current use of oral corticosteroids at a dose equivalent to \> 30 mg/day of prednisone
* Ulcerative colitis or indeterminate colitis
* Short bowel syndrome
* Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli, Salmonella, Shigella, Campylobacter or Yersinia
* Treatment with any monoclonal antibody within 4 weeks of screening
* History or evidence of colonic mucosal dysplasia
* HIV, hepatitis B, hepatitis C, or tuberculosis (TB) infection
* Participated in a clinical study with an investigational drug or biologic within the last 30 days
* Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) that, in the opinion of the investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol
18 Years
75 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Team
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Digestive Health Specialists of The Southeast
Dothan, Alabama, United States
Mayo Clinic
Scottsdale, Arizona, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
South Denver Gastroenterology
Lone Tree, Colorado, United States
University of Miami
Miami, Florida, United States
Gastroenterology Group Of Naples
Naples, Florida, United States
Gastroenterology Associates Of Central Georgia, LLC
Macon, Georgia, United States
Medical Diagnostic Center (MDC)-Indiana University (IU) Health University Hospital
Indianapolis, Indiana, United States
Iowa Digestive Disease Center
Clive, Iowa, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, United States
Delta Research Partners
Monroe, Louisiana, United States
Louisiana Research Center
Shreveport, Louisiana, United States
University of Michigan
Ann Arbor, Michigan, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey, United States
Columbia University Medical Center/ New York Presbyterian
New York, New York, United States
Premier Medical Group Of The Hudson Valley
Poughkeepsie, New York, United States
Mayo Clinic Rochester
Rochester, New York, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, United States
Consultants For Clinical Research
Cincinnati, Ohio, United States
Great Lakes Gastroenterology
Mentor, Ohio, United States
Gastro One
Germantown, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Clinical Research Institute
Arlington, Texas, United States
Ertan Digestive Disease Center of Excellence, UTH/MH-TMC
Houston, Texas, United States
Gastroenterology Research of San Antonio
San Antonio, Texas, United States
Gastroenterology Associates Of Tidewater
Chesapeake, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Mcguire Dvamc
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Footscray Hospital
Footscray, Victoria, Australia
Gastroenterology/Colorectal Medicine & Genetics
Melbourne, Victoria, Australia
Percuro Clinical Research Ltd.
Victoria, British Columbia, Canada
Percuro Clinical Research Ltd.
Victoria, , Canada
Hepato-Gastroenterologie Hk S.R.O.
Hradec Králové, , Czechia
Ibd Clinical And Research Centre-Iscare Ivf
Prague, , Czechia
Hopital Beaujon
Clichy, , France
CHRU de Lille
Lille, , France
Chu Hotel Dieu-Chu De Nantes
Nantes, , France
CHU de Saint Etienne - Hopital Nord
Saint-Priest-en-Jarez, , France
Universitatsklinikum Schleswig-Holstein
Kiel, , Germany
Eugastro Gmbh
Leipzig, , Germany
Klinikum der Universitat Munchen
München, , Germany
Tolna Megye Balassa Janos Korhaz
Beri Balogh Adam, , Hungary
Rethy Pal Hospital-Clinic Bekescsaba
Békéscsaba, , Hungary
Pannonia Maganorvosi Centrum Kft
Budapest, , Hungary
Debreceni Egyeterm Orvos es Egeszsegtudomanyi Centrum
Debrecen, , Hungary
Universita Campus Biomedico
Roma, , Italy
Humanitas Research Hospital
Rozzano, , Italy
Christchurch Hospital
Christchurch, , New Zealand
Southern District Health Board
Dunedin, , New Zealand
Capital and Coast District Health board-Wellington hospital
Wellington, , New Zealand
The Medical University of Bialystok Clinical
Bialystok, , Poland
Gastromed
Lublin, , Poland
Ai Centrum Medyczne
Poznan, , Poland
CRC Sp. z o.o.
Poznan, , Poland
Endoskopia SP. z.o.o.
Sopot, , Poland
Centralny Szpital Kliniczny MSWiA
Warsaw, , Poland
Lexmedica
Wroclaw, , Poland
Panorama Mediclinic Pvt Hospital
Panorama, Cape Town, South Africa
Parklands Medical Centre
Durban, , South Africa
Hospital Universitari de Bellvitge
Barcelona, , Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Norfolk and Norwich University Hospital Nhs Foundation Trust
Norwich, Norfolk, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
Oxford University Hospitals NHS Trust
Oxford, , United Kingdom
Countries
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References
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Schreiber S, Siegel CA, Friedenberg KA, Younes ZH, Seidler U, Bhandari BR, Wang K, Wendt E, McKevitt M, Zhao S, Sundy JS, Lee SD, Loftus EV. A Phase 2, Randomized, Placebo-Controlled Study Evaluating Matrix Metalloproteinase-9 Inhibitor, Andecaliximab, in Patients With Moderately to Severely Active Crohn's Disease. J Crohns Colitis. 2018 Aug 29;12(9):1014-1020. doi: 10.1093/ecco-jcc/jjy070.
Other Identifiers
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2015-001249-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-395-1663
Identifier Type: -
Identifier Source: org_study_id
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