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

Primary Purpose

Crohn's Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Andecaliximab
Placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Digestive Health Specialists of The Southeast
  • Mayo Clinic
  • Cedars Sinai Medical Center
  • South Denver Gastroenterology
  • University of Miami
  • Gastroenterology Group Of Naples
  • Gastroenterology Associates Of Central Georgia, LLC
  • Medical Diagnostic Center (MDC)-Indiana University (IU) Health University Hospital
  • Iowa Digestive Disease Center
  • Cotton-O'Neil Clinical Research Center, Digestive Health
  • Delta Research Partners
  • Louisiana Research Center
  • University of Michigan
  • Clinical Research Institute of Michigan, LLC
  • Mayo Clinic Rochester
  • Washington University School of Medicine
  • Dartmouth-Hitchcock Medical Center
  • AGA Clinical Research Associates, LLC
  • Columbia University Medical Center/ New York Presbyterian
  • Premier Medical Group Of The Hudson Valley
  • Mayo Clinic Rochester
  • Asheville Gastroenterology Associates
  • Consultants For Clinical Research
  • Great Lakes Gastroenterology
  • Gastro One
  • Vanderbilt University Medical Center
  • Texas Clinical Research Institute
  • Ertan Digestive Disease Center of Excellence, UTH/MH-TMC
  • Gastroenterology Research of San Antonio
  • Gastroenterology Associates Of Tidewater
  • Digestive and Liver Disease Specialists
  • Mcguire Dvamc
  • University of Washington Medical Center
  • Concord Repatriation General Hospital
  • Royal Adelaide Hospital
  • Flinders Medical Centre
  • Footscray Hospital
  • Gastroenterology/Colorectal Medicine & Genetics
  • Percuro Clinical Research Ltd.
  • Percuro Clinical Research Ltd.
  • Hepato-Gastroenterologie Hk S.R.O.
  • Ibd Clinical And Research Centre-Iscare Ivf
  • Hopital Beaujon
  • CHRU de Lille
  • Chu Hotel Dieu-Chu De Nantes
  • CHU de Saint Etienne - Hopital Nord
  • Universitatsklinikum Schleswig-Holstein
  • Eugastro Gmbh
  • Klinikum der Universitat Munchen
  • Rethy Pal Hospital-Clinic Bekescsaba
  • Tolna Megye Balassa Janos Korhaz
  • Pannonia Maganorvosi Centrum Kft
  • Debreceni Egyeterm Orvos es Egeszsegtudomanyi Centrum
  • Universita Campus Biomedico
  • Humanitas Research Hospital
  • Christchurch Hospital
  • Southern District Health Board
  • Capital and Coast District Health board-Wellington hospital
  • The Medical University of Bialystok Clinical
  • Gastromed
  • Ai Centrum Medyczne
  • CRC Sp. z o.o.
  • Endoskopia SP. z.o.o.
  • Centralny Szpital Kliniczny MSWiA
  • Lexmedica
  • Panorama Mediclinic Pvt Hospital
  • Parklands Medical Centre
  • Hospital Universitari de Bellvitge
  • Hospital Universitario de Fuenlabrada
  • Hospital Ramon y Cajal
  • Hospital Universitari i Politecnic La Fe de Valencia
  • Norfolk and Norwich University Hospital Nhs Foundation Trust
  • Cambridge University Hospitals NHS Foundation Trust
  • Oxford University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Andecaliximab 150 mg Every 2 Weeks

Andecaliximab 150 mg Weekly

Andecaliximab 300 mg Weekly

Placebo

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Clinical Response (PRO2 Score ≤ 8) at Week 8 of the Double-Blind Phase
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.
Percentage of Participants Achieving Endoscopic Response (≥ 50% Reduction From Baseline SES-CD) at Week 8 of the Double-Blind Phase
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

Percentage of Participants Achieving CDAI Remission (CDAI ≤ 150) at Week 8 of the Double-Blind Phase
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.
Percentage of Participants Achieving Mucosal Healing (SES-CD Size-of-Ulcer Subscore = 0) at Week 8 of the Double-Blind Phase
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.

Full Information

First Posted
March 27, 2015
Last Updated
April 11, 2019
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02405442
Brief Title
Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Study Start Date
April 30, 2015 (Actual)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
December 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Andecaliximab 150 mg Every 2 Weeks
Arm Type
Experimental
Arm Description
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.
Arm Title
Andecaliximab 150 mg Weekly
Arm Type
Experimental
Arm Description
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.
Arm Title
Andecaliximab 300 mg Weekly
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Andecaliximab
Other Intervention Name(s)
GS-5745
Intervention Description
Andecaliximab administered via subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match andecaliximab administered via SC injection
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Clinical Response (PRO2 Score ≤ 8) at Week 8 of the Double-Blind Phase
Description
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.
Time Frame
Week 8
Title
Percentage of Participants Achieving Endoscopic Response (≥ 50% Reduction From Baseline SES-CD) at Week 8 of the Double-Blind Phase
Description
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.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving CDAI Remission (CDAI ≤ 150) at Week 8 of the Double-Blind Phase
Description
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.
Time Frame
Week 8
Title
Percentage of Participants Achieving Mucosal Healing (SES-CD Size-of-Ulcer Subscore = 0) at Week 8 of the Double-Blind Phase
Description
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.
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Team
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Digestive Health Specialists of The Southeast
City
Dothan
State/Province
Alabama
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
South Denver Gastroenterology
City
Lone Tree
State/Province
Colorado
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
Country
United States
Facility Name
Gastroenterology Group Of Naples
City
Naples
State/Province
Florida
Country
United States
Facility Name
Gastroenterology Associates Of Central Georgia, LLC
City
Macon
State/Province
Georgia
Country
United States
Facility Name
Medical Diagnostic Center (MDC)-Indiana University (IU) Health University Hospital
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Iowa Digestive Disease Center
City
Clive
State/Province
Iowa
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center, Digestive Health
City
Topeka
State/Province
Kansas
Country
United States
Facility Name
Delta Research Partners
City
Monroe
State/Province
Louisiana
Country
United States
Facility Name
Louisiana Research Center
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
Country
United States
Facility Name
AGA Clinical Research Associates, LLC
City
Egg Harbor Township
State/Province
New Jersey
Country
United States
Facility Name
Columbia University Medical Center/ New York Presbyterian
City
New York
State/Province
New York
Country
United States
Facility Name
Premier Medical Group Of The Hudson Valley
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
New York
Country
United States
Facility Name
Asheville Gastroenterology Associates
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
Consultants For Clinical Research
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Great Lakes Gastroenterology
City
Mentor
State/Province
Ohio
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Texas Clinical Research Institute
City
Arlington
State/Province
Texas
Country
United States
Facility Name
Ertan Digestive Disease Center of Excellence, UTH/MH-TMC
City
Houston
State/Province
Texas
Country
United States
Facility Name
Gastroenterology Research of San Antonio
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Gastroenterology Associates Of Tidewater
City
Chesapeake
State/Province
Virginia
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Mcguire Dvamc
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
Country
Australia
Facility Name
Footscray Hospital
City
Footscray
State/Province
Victoria
Country
Australia
Facility Name
Gastroenterology/Colorectal Medicine & Genetics
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Percuro Clinical Research Ltd.
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Percuro Clinical Research Ltd.
City
Victoria
Country
Canada
Facility Name
Hepato-Gastroenterologie Hk S.R.O.
City
Hradec Kralove 2
Country
Czechia
Facility Name
Ibd Clinical And Research Centre-Iscare Ivf
City
Praha 7
Country
Czechia
Facility Name
Hopital Beaujon
City
Clichy Cedex
Country
France
Facility Name
CHRU de Lille
City
Lille
Country
France
Facility Name
Chu Hotel Dieu-Chu De Nantes
City
Nantes
Country
France
Facility Name
CHU de Saint Etienne - Hopital Nord
City
Saint Priest en Jarez
Country
France
Facility Name
Universitatsklinikum Schleswig-Holstein
City
Kiel
Country
Germany
Facility Name
Eugastro Gmbh
City
Leipzig
Country
Germany
Facility Name
Klinikum der Universitat Munchen
City
Muenchen
Country
Germany
Facility Name
Rethy Pal Hospital-Clinic Bekescsaba
City
Bekescsaba
Country
Hungary
Facility Name
Tolna Megye Balassa Janos Korhaz
City
Beri Balogh Adam
Country
Hungary
Facility Name
Pannonia Maganorvosi Centrum Kft
City
Budapest
Country
Hungary
Facility Name
Debreceni Egyeterm Orvos es Egeszsegtudomanyi Centrum
City
Debrecen
Country
Hungary
Facility Name
Universita Campus Biomedico
City
Roma
Country
Italy
Facility Name
Humanitas Research Hospital
City
Rozzano
Country
Italy
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
Southern District Health Board
City
Dunedin
Country
New Zealand
Facility Name
Capital and Coast District Health board-Wellington hospital
City
Wellington
Country
New Zealand
Facility Name
The Medical University of Bialystok Clinical
City
Bialystok
Country
Poland
Facility Name
Gastromed
City
Lublin
Country
Poland
Facility Name
Ai Centrum Medyczne
City
Poznan
Country
Poland
Facility Name
CRC Sp. z o.o.
City
Poznan
Country
Poland
Facility Name
Endoskopia SP. z.o.o.
City
Sopot
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA
City
Warszawa
Country
Poland
Facility Name
Lexmedica
City
Wroclaw
Country
Poland
Facility Name
Panorama Mediclinic Pvt Hospital
City
Panorama
State/Province
Cape Town
Country
South Africa
Facility Name
Parklands Medical Centre
City
Durban
Country
South Africa
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada
City
Fuenlabrada
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
Country
Spain
Facility Name
Norfolk and Norwich University Hospital Nhs Foundation Trust
City
Norwich
State/Province
Norfolk
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Trust
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29846530
Citation
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.
Results Reference
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Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease

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