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Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease

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ClinicalTrials.gov Identifier: NCT02405442
Recruitment Status : Terminated
First Posted : April 1, 2015
Results First Posted : March 28, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This study will primarily evaluate the safety and efficacy of andecaliximab in adults with active Crohn's disease. The study will consist of a Double-Blind Phase of 8 weeks followed by an Open-Label Extension. Participants who complete the Double-Blind Phase will be eligible to enroll in the optional Open-Label Extension for an additional 44 weeks. Participants who complete Week 52 assessments will be eligible to enter the Extended Treatment Phase to continue treatment with andecaliximab for an additional 156 weeks.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Andecaliximab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Crohn's Disease
Actual Study Start Date : April 30, 2015
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : December 22, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: 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.
Drug: Andecaliximab
Andecaliximab administered via subcutaneous (SC) injection
Other Name: GS-5745

Drug: Placebo
Placebo to match andecaliximab administered via SC injection

Experimental: 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.
Drug: Andecaliximab
Andecaliximab administered via subcutaneous (SC) injection
Other Name: GS-5745

Drug: Placebo
Placebo to match andecaliximab administered via SC injection

Experimental: 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.
Drug: Andecaliximab
Andecaliximab administered via subcutaneous (SC) injection
Other Name: GS-5745

Placebo Comparator: 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.
Drug: Andecaliximab
Andecaliximab administered via subcutaneous (SC) injection
Other Name: GS-5745

Drug: Placebo
Placebo to match andecaliximab administered via SC injection




Primary Outcome Measures :
  1. Percentage of Participants Achieving Clinical Response (PRO2 Score ≤ 8) at Week 8 of the Double-Blind Phase [ Time Frame: Week 8 ]
    Clinical response was defined as patient-reported outcomes (PRO2) score ≤ 8 at Week 8. PRO2 is the weighted average of the 2 variables of frequency of liquid or very soft stool and abdominal pain, based on 7-day participant diary data. The PRO2 score has a minimum score of 0 and has no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with a missing PRO2 value at the Week 8 analysis visit were imputed as not achieving the Clinical Response.

  2. Percentage of Participants Achieving Endoscopic Response (≥ 50% Reduction From Baseline SES-CD) at Week 8 of the Double-Blind Phase [ Time Frame: Week 8 ]
    Endoscopic response was defined as ≥ 50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 8. The SES-CD evaluates 4 endoscopic variables: ulcer size, ulcerated surface, affected surface, and presence of narrowings. The total SES-CD is calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing SES-CD value at Week 8 analysis visit were imputed as not achieving Endoscopic Response.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving CDAI Remission (CDAI ≤ 150) at Week 8 of the Double-Blind Phase [ Time Frame: Week 8 ]
    Clinical remission was defined as Crohn's Disease Activity Index (CDAI) ≤ 150 at Week 8. CDAI is used as a measure of clinical response and remission. It includes 8 variables of patient-reported symptoms and objective variables: stool count, abdominal pain, general well-being, complications, use of anti-diarrheal medications, presence of abdominal mass, hematocrit values, and weight. It has a minimum range of 0 and no upper bound, with higher scores indicating greater disease activity. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing CDAI score at Week 8 analysis visit were imputed as not achieving CDAI Remission.

  2. Percentage of Participants Achieving Mucosal Healing (SES-CD Size-of-Ulcer Subscore = 0) at Week 8 of the Double-Blind Phase [ Time Frame: Week 8 ]
    The SES-CD evaluates 4 endoscopic variables: ulcer size, ulcerated surface, affected surface, and presence of narrowings. The SES-CD size-of-ulcer subscore ranges from 0 (none) to 3 (very large). Mucosal healing at Week 8 was defined as the size-of-ulcer subscore for segments with non-zero baseline value changes to zero at Week 8 AND the size-of-ulcer subscore for segments with zero value at baseline remain zero at Week 8. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing SES-CD size-of-ulcer subscore at Week 8 analysis visit were imputed as not achieving Mucosal Healing.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Ability to provide a written informed consent
  • 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

Key Exclusion Criteria:

  • Evidence of abscess at screening
  • 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

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405442


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Locations
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United States, Alabama
Digestive Health Specialists of The Southeast
Dothan, Alabama, United States
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States
United States, Colorado
South Denver Gastroenterology
Lone Tree, Colorado, United States
United States, Florida
University of Miami
Miami, Florida, United States
Gastroenterology Group Of Naples
Naples, Florida, United States
United States, Georgia
Gastroenterology Associates Of Central Georgia, LLC
Macon, Georgia, United States
United States, Indiana
Medical Diagnostic Center (MDC)-Indiana University (IU) Health University Hospital
Indianapolis, Indiana, United States
United States, Iowa
Iowa Digestive Disease Center
Clive, Iowa, United States
United States, Kansas
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, United States
United States, Louisiana
Delta Research Partners
Monroe, Louisiana, United States
Louisiana Research Center
Shreveport, Louisiana, United States
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
United States, New Jersey
AGA Clinical Research Associates, LLC
Egg Harbor Township, New Jersey, United States
United States, New York
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
United States, North Carolina
Asheville Gastroenterology Associates
Asheville, North Carolina, United States
United States, Ohio
Consultants For Clinical Research
Cincinnati, Ohio, United States
Great Lakes Gastroenterology
Mentor, Ohio, United States
United States, Tennessee
Gastro One
Germantown, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
United States, Texas
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
United States, Virginia
Gastroenterology Associates Of Tidewater
Chesapeake, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Mcguire Dvamc
Richmond, Virginia, United States
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States
Australia, New South Wales
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Australia, Victoria
Footscray Hospital
Footscray, Victoria, Australia
Gastroenterology/Colorectal Medicine & Genetics
Melbourne, Victoria, Australia
Canada, British Columbia
Percuro Clinical Research Ltd.
Victoria, British Columbia, Canada
Canada
Percuro Clinical Research Ltd.
Victoria, Canada
Czechia
Hepato-Gastroenterologie Hk S.R.O.
Hradec Kralove 2, Czechia
Ibd Clinical And Research Centre-Iscare Ivf
Praha 7, Czechia
France
Hopital Beaujon
Clichy Cedex, 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
Germany
Universitatsklinikum Schleswig-Holstein
Kiel, Germany
Eugastro Gmbh
Leipzig, Germany
Klinikum der Universitat Munchen
Muenchen, Germany
Hungary
Rethy Pal Hospital-Clinic Bekescsaba
Bekescsaba, Hungary
Tolna Megye Balassa Janos Korhaz
Beri Balogh Adam, Hungary
Pannonia Maganorvosi Centrum Kft
Budapest, Hungary
Debreceni Egyeterm Orvos es Egeszsegtudomanyi Centrum
Debrecen, Hungary
Italy
Universita Campus Biomedico
Roma, Italy
Humanitas Research Hospital
Rozzano, Italy
New Zealand
Christchurch Hospital
Christchurch, New Zealand
Southern District Health Board
Dunedin, New Zealand
Capital and Coast District Health board-Wellington hospital
Wellington, New Zealand
Poland
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
Warszawa, Poland
Lexmedica
Wroclaw, Poland
South Africa
Panorama Mediclinic Pvt Hospital
Panorama, Cape Town, South Africa
Parklands Medical Centre
Durban, South Africa
Spain
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
United Kingdom
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
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Team Gilead Sciences

Publications of Results:
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02405442     History of Changes
Other Study ID Numbers: GS-US-395-1663
2015-001249-10 ( EudraCT Number )
First Posted: April 1, 2015    Key Record Dates
Results First Posted: March 28, 2019
Last Update Posted: April 23, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs