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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02405442




Registration number
NCT02405442
Ethics application status
Date submitted
27/03/2015
Date registered
1/04/2015
Date last updated
23/04/2019

Titles & IDs
Public title
Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease
Scientific 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
Secondary ID [1] 0 0
2015-001249-10
Secondary ID [2] 0 0
GS-US-395-1663
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Andecaliximab
Treatment: Drugs - Placebo

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.

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.

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.

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.


Treatment: Drugs: Andecaliximab
Andecaliximab administered via subcutaneous (SC) injection

Treatment: Drugs: Placebo
Placebo to match andecaliximab administered via SC injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Clinical Response (PRO2 Score = 8) at Week 8 of the Double-Blind Phase
Timepoint [1] 0 0
Week 8
Primary outcome [2] 0 0
Percentage of Participants Achieving Endoscopic Response (= 50% Reduction From Baseline SES-CD) at Week 8 of the Double-Blind Phase
Timepoint [2] 0 0
Week 8
Secondary outcome [1] 0 0
Percentage of Participants Achieving CDAI Remission (CDAI = 150) at Week 8 of the Double-Blind Phase
Timepoint [1] 0 0
Week 8
Secondary outcome [2] 0 0
Percentage of Participants Achieving Mucosal Healing (SES-CD Size-of-Ulcer Subscore = 0) at Week 8 of the Double-Blind Phase
Timepoint [2] 0 0
Week 8

Eligibility
Key inclusion criteria
Key

* 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 (TNFa) 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/12/2016
Sample size
Target
Accrual to date
Final
187
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 0 0
Footscray Hospital - Footscray
Recruitment hospital [5] 0 0
Gastroenterology/Colorectal Medicine & Genetics - Melbourne
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Bedford Park
Recruitment postcode(s) [4] 0 0
- Footscray
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
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State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
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United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
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Kansas
Country [10] 0 0
United States of America
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Louisiana
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Michigan
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Minnesota
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Missouri
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New Hampshire
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New Jersey
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New York
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North Carolina
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Ohio
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Tennessee
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Texas
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Virginia
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United States of America
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Washington
Country [23] 0 0
Canada
State/province [23] 0 0
British Columbia
Country [24] 0 0
Canada
State/province [24] 0 0
Victoria
Country [25] 0 0
Czechia
State/province [25] 0 0
Hradec Kralove 2
Country [26] 0 0
Czechia
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Praha 7
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France
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Clichy Cedex
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France
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Lille
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France
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Nantes
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France
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Saint Priest en Jarez
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Germany
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Kiel
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Germany
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Leipzig
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Germany
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Muenchen
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Hungary
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Bekescsaba
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Hungary
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Beri Balogh Adam
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Budapest
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Hungary
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Debrecen
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Italy
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Roma
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Italy
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Rozzano
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New Zealand
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Christchurch
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New Zealand
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Dunedin
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New Zealand
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Wellington
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Poland
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Bialystok
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Lublin
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Poznan
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Sopot
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Poland
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Warszawa
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Poland
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Wroclaw
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South Africa
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Cape Town
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South Africa
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Durban
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Spain
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Barcelona
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Spain
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Fuenlabrada
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Spain
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Madrid
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Spain
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Valencia
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United Kingdom
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Norfolk
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United Kingdom
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Cambridge
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United Kingdom
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Team
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Schreiber S, Siegel CA, Friedenberg KA, Younes ZH,... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT02405442