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

April 11, 2019 updated by: Gilead Sciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
187

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia
        • Concord Repatriation General Hospital
    • South Australia
      • Adelaide, South Australia, Australia
        • Royal Adelaide Hospital
      • Bedford Park, South Australia, Australia
        • Flinders Medical Centre
    • Victoria
      • Footscray, Victoria, Australia
        • Footscray Hospital
      • Melbourne, Victoria, Australia
        • Gastroenterology/Colorectal Medicine & Genetics
  • Canada
      • Victoria, Canada
        • PerCuro Clinical Research Ltd.
    • British Columbia
      • Victoria, British Columbia, Canada
        • PerCuro Clinical Research Ltd.
  • Czechia
      • Hradec Kralove 2, Czechia
        • Hepato-Gastroenterologie HK s.r.o.
      • Praha 7, Czechia
        • Ibd Clinical And Research Centre-Iscare Ivf
  • France
      • Clichy Cedex, France
        • Hopital Beaujon
      • Lille, France
        • CHRU de Lille
      • Nantes, France
        • Chu Hotel Dieu-Chu De Nantes
      • Saint Priest en Jarez, France
        • CHU de Saint Etienne - Hopital Nord
  • Germany
      • Kiel, Germany
        • Universitätsklinikum Schleswig-Holstein
      • Leipzig, Germany
        • Eugastro GmbH
      • Muenchen, Germany
        • Klinikum der Universität München
  • Hungary
      • Bekescsaba, Hungary
        • Rethy Pal Hospital-Clinic Bekescsaba
      • Beri Balogh Adam, Hungary
        • Tolna Megye Balassa Janos Korhaz
      • Budapest, Hungary
        • Pannónia Magánorvosi Centrum Kft
      • Debrecen, Hungary
        • Debreceni Egyeterm Orvos es Egeszsegtudomanyi Centrum
  • Italy
      • Roma, Italy
        • Università Campus Biomedico
      • Rozzano, Italy
        • Humanitas Research Hospital
  • New Zealand
      • Christchurch, New Zealand
        • Christchurch Hospital
      • Dunedin, New Zealand
        • Southern District Health Board
      • Wellington, New Zealand
        • Capital and Coast District Health board-Wellington hospital
  • Poland
      • Bialystok, Poland
        • The Medical University of Bialystok Clinical
      • Lublin, Poland
        • Gastromed
      • Poznan, Poland
        • AI Centrum Medyczne
      • Poznan, Poland
        • CRC Sp. z o.o.
      • Sopot, Poland
        • Endoskopia Sp. z.o.o.
      • Warszawa, Poland
        • Centralny Szpital Kliniczny Mswia
      • Wroclaw, Poland
        • LexMedica
  • South Africa
      • Durban, South Africa
        • Parklands Medical Centre
    • Cape Town
      • Panorama, Cape Town, South Africa
        • Panorama Mediclinic Pvt Hospital
  • Spain
      • Barcelona, Spain
        • Hospital Universitari de Bellvitge
      • Fuenlabrada, Spain
        • Hospital Universitario de Fuenlabrada
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Valencia, Spain
        • Hospital Universitari i Politecnic La Fe de Valencia
  • United Kingdom
      • Cambridge, United Kingdom
        • Cambridge University Hospitals NHS Foundation Trust
      • Oxford, United Kingdom
        • Oxford University Hospitals NHS Trust
    • Norfolk
      • Norwich, Norfolk, United Kingdom
        • Norfolk and Norwich University Hospital NHS Foundation Trust
  • United States
    • Alabama
      • Dothan, Alabama, United States
        • Digestive Health Specialists of the Southeast
    • Arizona
      • Scottsdale, Arizona, United States
        • Mayo Clinic
    • California
      • Los Angeles, California, United States
        • Cedars Sinai Medical Center
    • Colorado
      • Lone Tree, Colorado, United States
        • South Denver Gastroenterology
    • Florida
      • Miami, Florida, United States
        • University of Miami
      • Naples, Florida, United States
        • Gastroenterology Group Of Naples
    • Georgia
      • Macon, Georgia, United States
        • Gastroenterology Associates Of Central Georgia, LLC
    • Indiana
      • Indianapolis, Indiana, United States
        • Medical Diagnostic Center (MDC)-Indiana University (IU) Health University Hospital
    • Iowa
      • Clive, Iowa, United States
        • Iowa Digestive Disease Center
    • Kansas
      • Topeka, Kansas, United States
        • Cotton-O'Neil Clinical Research Center, Digestive Health
    • Louisiana
      • Monroe, Louisiana, United States
        • Delta Research Partners
      • Shreveport, Louisiana, United States
        • Louisiana Research Center
    • Michigan
      • Ann Arbor, Michigan, United States
        • University of Michigan
      • Chesterfield, Michigan, United States
        • Clinical Research Institute of Michigan, LLC
    • Minnesota
      • Rochester, Minnesota, United States
        • Mayo Clinic Rochester
    • Missouri
      • Saint Louis, Missouri, United States
        • Washington University School of Medicine
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Egg Harbor Township, New Jersey, United States
        • AGA Clinical Research Associates, LLC
    • New York
      • New York, New York, United States
        • Columbia University Medical Center/ New York Presbyterian
      • Poughkeepsie, New York, United States
        • Premier Medical Group of the Hudson Valley
      • Rochester, New York, United States
        • Mayo Clinic Rochester
    • North Carolina
      • Asheville, North Carolina, United States
        • Asheville Gastroenterology Associates
    • Ohio
      • Cincinnati, Ohio, United States
        • Consultants for Clinical Research
      • Mentor, Ohio, United States
        • Great Lakes Gastroenterology
    • Tennessee
      • Germantown, Tennessee, United States
        • Gastro One
      • Nashville, Tennessee, United States
        • Vanderbilt University Medical Center
    • Texas
      • Arlington, Texas, United States
        • Texas Clinical Research Institute
      • Houston, Texas, United States
        • Ertan Digestive Disease Center of Excellence, UTH/MH-TMC
      • San Antonio, Texas, United States
        • Gastroenterology Research of San Antonio
    • Virginia
      • Chesapeake, Virginia, United States
        • Gastroenterology Associates of Tidewater
      • Norfolk, Virginia, United States
        • Digestive and Liver Disease Specialists
      • Richmond, Virginia, United States
        • McGuire DVAMC
    • Washington
      • Seattle, Washington, United States
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • GS-5745
Drug: Placebo
Placebo to match andecaliximab administered via SC injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Week 8
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.
Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Week 8
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.
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gilead Study Team, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS-US-395-1663
  • 2015-001249-10 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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