Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Query!
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
Query!
Secondary ID [1]
0
0
2015-001249-10
Query!
Secondary ID [2]
0
0
GS-US-395-1663
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Inflammatory bowel disease
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Crohn's disease
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants Achieving Clinical Response (PRO2 Score = 8) at Week 8 of the Double-Blind Phase
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Week 8
Query!
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
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Week 8
Query!
Secondary outcome [1]
0
0
Percentage of Participants Achieving CDAI Remission (CDAI = 150) at Week 8 of the Double-Blind Phase
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Week 8
Query!
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
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Week 8
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
30/04/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
22/12/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
187
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Query!
Recruitment hospital [1]
0
0
Concord Repatriation General Hospital - Concord
Query!
Recruitment hospital [2]
0
0
Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [3]
0
0
Flinders Medical Centre - Bedford Park
Query!
Recruitment hospital [4]
0
0
Footscray Hospital - Footscray
Query!
Recruitment hospital [5]
0
0
Gastroenterology/Colorectal Medicine & Genetics - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
- Concord
Query!
Recruitment postcode(s) [2]
0
0
- Adelaide
Query!
Recruitment postcode(s) [3]
0
0
- Bedford Park
Query!
Recruitment postcode(s) [4]
0
0
- Footscray
Query!
Recruitment postcode(s) [5]
0
0
- Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Indiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Iowa
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kansas
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Louisiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Minnesota
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Missouri
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Hampshire
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New Jersey
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New York
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
North Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Ohio
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Tennessee
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Texas
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Virginia
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Washington
Query!
Country [23]
0
0
Canada
Query!
State/province [23]
0
0
British Columbia
Query!
Country [24]
0
0
Canada
Query!
State/province [24]
0
0
Victoria
Query!
Country [25]
0
0
Czechia
Query!
State/province [25]
0
0
Hradec Kralove 2
Query!
Country [26]
0
0
Czechia
Query!
State/province [26]
0
0
Praha 7
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Clichy Cedex
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Lille
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Nantes
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Saint Priest en Jarez
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Kiel
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Leipzig
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Muenchen
Query!
Country [34]
0
0
Hungary
Query!
State/province [34]
0
0
Bekescsaba
Query!
Country [35]
0
0
Hungary
Query!
State/province [35]
0
0
Beri Balogh Adam
Query!
Country [36]
0
0
Hungary
Query!
State/province [36]
0
0
Budapest
Query!
Country [37]
0
0
Hungary
Query!
State/province [37]
0
0
Debrecen
Query!
Country [38]
0
0
Italy
Query!
State/province [38]
0
0
Roma
Query!
Country [39]
0
0
Italy
Query!
State/province [39]
0
0
Rozzano
Query!
Country [40]
0
0
New Zealand
Query!
State/province [40]
0
0
Christchurch
Query!
Country [41]
0
0
New Zealand
Query!
State/province [41]
0
0
Dunedin
Query!
Country [42]
0
0
New Zealand
Query!
State/province [42]
0
0
Wellington
Query!
Country [43]
0
0
Poland
Query!
State/province [43]
0
0
Bialystok
Query!
Country [44]
0
0
Poland
Query!
State/province [44]
0
0
Lublin
Query!
Country [45]
0
0
Poland
Query!
State/province [45]
0
0
Poznan
Query!
Country [46]
0
0
Poland
Query!
State/province [46]
0
0
Sopot
Query!
Country [47]
0
0
Poland
Query!
State/province [47]
0
0
Warszawa
Query!
Country [48]
0
0
Poland
Query!
State/province [48]
0
0
Wroclaw
Query!
Country [49]
0
0
South Africa
Query!
State/province [49]
0
0
Cape Town
Query!
Country [50]
0
0
South Africa
Query!
State/province [50]
0
0
Durban
Query!
Country [51]
0
0
Spain
Query!
State/province [51]
0
0
Barcelona
Query!
Country [52]
0
0
Spain
Query!
State/province [52]
0
0
Fuenlabrada
Query!
Country [53]
0
0
Spain
Query!
State/province [53]
0
0
Madrid
Query!
Country [54]
0
0
Spain
Query!
State/province [54]
0
0
Valencia
Query!
Country [55]
0
0
United Kingdom
Query!
State/province [55]
0
0
Norfolk
Query!
Country [56]
0
0
United Kingdom
Query!
State/province [56]
0
0
Cambridge
Query!
Country [57]
0
0
United Kingdom
Query!
State/province [57]
0
0
Oxford
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Gilead Sciences
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02405442
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Gilead Study Team
Query!
Address
0
0
Gilead Sciences
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02405442
Download to PDF