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 ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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/study/NCT02520284
Registration number
NCT02520284
Ethics application status
Date submitted
7/08/2015
Date registered
11/08/2015
Date last updated
10/04/2019
Titles & IDs
Public title
Safety and Efficacy of Andecaliximab (GS-5745) in Adults With Moderately to Severely Active Ulcerative Colitis
Query!
Scientific title
A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Ulcerative Colitis
Query!
Secondary ID [1]
0
0
2014-005217-24
Query!
Secondary ID [2]
0
0
GS-US-326-1100
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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!
Inflammatory bowel disease
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Other - Andecaliximab
Treatment: Other - Placebo
Experimental: Andecaliximab Every 2 Weeks - Participants will receive andecaliximab 150 mg administered via subcutaneous (SC) injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab. Based on Week 8 assessment results, participants will either continue in Blinded Maintenance Treatment phase or will be offered Open-Label andecaliximab 150 mg administered via SC injection weekly for up to Week 51.
Experimental: Andecaliximab Weekly - Participants will receive andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses. Based on Week 8 assessment results, participants will either continue in Blinded Maintenance Treatment phase or will be offered Open-Label andecaliximab 150 mg administered via SC injection weekly for up to Week 51.
Placebo comparator: Placebo - Participants will receive placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses. Based on Week 8 assessment results, participants will either continue in Blinded Maintenance Treatment phase or will be offered Open-Label andecaliximab 150 mg administered via SC injection weekly for up to Week 51.
Treatment: Other: Andecaliximab
Andecaliximab 150 mg administered via SC injection
Treatment: Other: Placebo
Placebo matched to andecaliximab administered via SC injection
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
For Cohort 1, Percentage of Participants With EBS Clinical Remission at Week 8
Query!
Assessment method [1]
0
0
EBS clinical remission was defined as an endoscopic subscore of 0 or 1 (endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]); rectal bleeding subscore of 0 (rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes); and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1 (stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal).
Query!
Timepoint [1]
0
0
Week 8
Query!
Secondary outcome [1]
0
0
For Cohort 1, Percentage of Participants With MCS Remission at Week 8
Query!
Assessment method [1]
0
0
The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and physician's global assessment (PGA). The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. The MCS remission was defined as a MCS of = 2 points and no individual subscore \> 1 point. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating disease worsening.
Query!
Timepoint [1]
0
0
Week 8
Query!
Secondary outcome [2]
0
0
For Cohort 1, Percentage of Participants With MCS Response at Week 8
Query!
Assessment method [2]
0
0
The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and PGA. The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating disease worsening. The MCS response was defined as a MCS reduction of = 3 points and at least 30% from baseline, with an accompanying decrease in rectal bleeding subscore of = 1 point or an absolute rectal bleeding subscore of 0 or 1.
Query!
Timepoint [2]
0
0
Week 8
Query!
Secondary outcome [3]
0
0
For Cohort 1, Percentage of Participants With Endoscopic Remission at Week 8
Query!
Assessment method [3]
0
0
Endoscopic remission was defined as endoscopic subscore of 0. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
Query!
Timepoint [3]
0
0
Week 8
Query!
Secondary outcome [4]
0
0
For Cohort 1, Percentage of Participants With Endoscopic Response at Week 8
Query!
Assessment method [4]
0
0
Endoscopic response was defined as endoscopic subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
Query!
Timepoint [4]
0
0
Week 8
Query!
Secondary outcome [5]
0
0
For Cohort 1, Percentage of Participants With Mucosal Healing as Determined by the Geboes Histologic Scoring System at Week 8
Query!
Assessment method [5]
0
0
Mucosal healing was defined as elimination of ulcers/erosion, elimination of crypt destruction, elimination of intraepithelial neutrophils, elimination of lamina propria neutrophils, and reduction in lamina propria chronic inflammatory cells to at most a mild increase. When measured by the Geboes histologic scoring system, it was the selection of the following combined scores of = 3 for Grade 0 (Structural Architectural Change), = 1 for Grade 1 (Chronic Inflammatory Infiltrate), = 3 for Grade 2A (Lamina Propria Eosinophils), and 0 for Grade 2B (Lamina Propria Neutrophils), Grade 3 (Neutrophils in Epithelium), Grade 4 (Crypt Destruction), and Grade 5 (Erosion or Ulceration). Total Geboes histologic score ranged from 0 to 22, with higher scores indicating greater disease severity.
Query!
Timepoint [5]
0
0
Week 8
Query!
Secondary outcome [6]
0
0
For Cohort 1, Percentage of Participants With MCS Remission (Alternative Definition) at Week 8
Query!
Assessment method [6]
0
0
The MCS remission (alternative definition) was defined as a rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and PGA subscore (range: 0 to 3 with higher score indicating the severe disease) of 0, and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]) of 0 or 1 for an overall MCS of = 1. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating disease worsening.
Query!
Timepoint [6]
0
0
Week 8
Query!
Eligibility
Key inclusion criteria
Key
* Ulcerative Colitis (UC) confirmed on endoscopy
* Moderately to severely active UC (Mayo Score 6-12)
* May be receiving oral 5-aminosalicylate (ASA), oral corticosteroid, azathioprine, 6-mercaptopurine (MP), or methotrexate
* Treatment failure with at least one of the following agents received: corticosteroids, immunomodulators, tumor necrosis factor-alpha (TNFa) antagonists, vedolizumab
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
* Diagnose of Crohn's disease or indeterminate colitis
* Pregnant or lactating females
* Any chronic medical condition (including, but not limited to cardiac or pulmonary disease, alcohol or drug abuse)
* Exhibit severe UC / clinically significant active infection
* History of malignancy in the last 5 years
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
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/09/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/11/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
165
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Footscray
Query!
Recruitment hospital [2]
0
0
- Herston
Query!
Recruitment hospital [3]
0
0
- Malvern
Query!
Recruitment hospital [4]
0
0
- Melbourne
Query!
Recruitment postcode(s) [1]
0
0
- Footscray
Query!
Recruitment postcode(s) [2]
0
0
- Herston
Query!
Recruitment postcode(s) [3]
0
0
- Malvern
Query!
Recruitment postcode(s) [4]
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
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kansas
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Kentucky
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Louisiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Michigan
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Minnesota
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Missouri
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New Jersey
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New York
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
North Carolina
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Ohio
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Tennessee
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Texas
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Virginia
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Washington
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Wisconsin
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Gent
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Leuven
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Mouscron
Query!
Country [23]
0
0
Bulgaria
Query!
State/province [23]
0
0
Pleven
Query!
Country [24]
0
0
Canada
Query!
State/province [24]
0
0
British Columbia
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
Ontario
Query!
Country [26]
0
0
Czechia
Query!
State/province [26]
0
0
Hradec Kralove
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Nantes
Query!
Country [28]
0
0
Hungary
Query!
State/province [28]
0
0
Bekescsaba
Query!
Country [29]
0
0
Hungary
Query!
State/province [29]
0
0
Budapest
Query!
Country [30]
0
0
Hungary
Query!
State/province [30]
0
0
Debrecen
Query!
Country [31]
0
0
Ireland
Query!
State/province [31]
0
0
Leinster
Query!
Country [32]
0
0
Italy
Query!
State/province [32]
0
0
Rozzano
Query!
Country [33]
0
0
Italy
Query!
State/province [33]
0
0
San Giovanni Rotondo
Query!
Country [34]
0
0
Korea, Republic of
Query!
State/province [34]
0
0
Seoul
Query!
Country [35]
0
0
Korea, Republic of
Query!
State/province [35]
0
0
Suwon-si
Query!
Country [36]
0
0
Latvia
Query!
State/province [36]
0
0
Daugavpils
Query!
Country [37]
0
0
Netherlands
Query!
State/province [37]
0
0
Amsterdam
Query!
Country [38]
0
0
New Zealand
Query!
State/province [38]
0
0
Canterbury Region
Query!
Country [39]
0
0
New Zealand
Query!
State/province [39]
0
0
Auckland
Query!
Country [40]
0
0
New Zealand
Query!
State/province [40]
0
0
Wellington
Query!
Country [41]
0
0
Poland
Query!
State/province [41]
0
0
Bialystok
Query!
Country [42]
0
0
Poland
Query!
State/province [42]
0
0
Krakow
Query!
Country [43]
0
0
Poland
Query!
State/province [43]
0
0
Lublin
Query!
Country [44]
0
0
Poland
Query!
State/province [44]
0
0
Piaseczno
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
Sroda Wielkopolska
Query!
Country [48]
0
0
Poland
Query!
State/province [48]
0
0
Tychy
Query!
Country [49]
0
0
Poland
Query!
State/province [49]
0
0
Warszawa
Query!
Country [50]
0
0
Poland
Query!
State/province [50]
0
0
Wroclaw
Query!
Country [51]
0
0
Romania
Query!
State/province [51]
0
0
Bucharest
Query!
Country [52]
0
0
Romania
Query!
State/province [52]
0
0
Timisoara
Query!
Country [53]
0
0
Russian Federation
Query!
State/province [53]
0
0
Moscow
Query!
Country [54]
0
0
Russian Federation
Query!
State/province [54]
0
0
Novosibirsk
Query!
Country [55]
0
0
Russian Federation
Query!
State/province [55]
0
0
Rostov-on-Don
Query!
Country [56]
0
0
Russian Federation
Query!
State/province [56]
0
0
Saint-Petersburg
Query!
Country [57]
0
0
Russian Federation
Query!
State/province [57]
0
0
St. Petersburg
Query!
Country [58]
0
0
Slovakia
Query!
State/province [58]
0
0
Trencin
Query!
Country [59]
0
0
South Africa
Query!
State/province [59]
0
0
Western Cape
Query!
Country [60]
0
0
Switzerland
Query!
State/province [60]
0
0
Basel
Query!
Country [61]
0
0
Switzerland
Query!
State/province [61]
0
0
Bern
Query!
Country [62]
0
0
Taiwan
Query!
State/province [62]
0
0
Taichung
Query!
Country [63]
0
0
Ukraine
Query!
State/province [63]
0
0
Kharkov
Query!
Country [64]
0
0
Ukraine
Query!
State/province [64]
0
0
Kyiv
Query!
Country [65]
0
0
Ukraine
Query!
State/province [65]
0
0
Lviv
Query!
Country [66]
0
0
Ukraine
Query!
State/province [66]
0
0
Odessa
Query!
Country [67]
0
0
Ukraine
Query!
State/province [67]
0
0
Vinnitsa
Query!
Country [68]
0
0
United Kingdom
Query!
State/province [68]
0
0
Cambridge
Query!
Country [69]
0
0
United Kingdom
Query!
State/province [69]
0
0
Oxford
Query!
Country [70]
0
0
United Kingdom
Query!
State/province [70]
0
0
Prescot
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
The primary objectives of this study are as follows: 1) To evaluate the efficacy of andecaliximab to induce endoscopy, rectal bleeding, and stool frequency (EBS) clinical remission at Week 8 (Cohort 1); 2) To evaluate the efficacy of andecaliximab to maintain EBS clinical remission at Week 52 (Cohort 2); and 3) To evaluate the safety and tolerability of andecaliximab. The study will consist of 3 parts: Induction Phase (Cohort 1), Maintenance Phase (Cohort 2), and an optional Extended Treatment Phase.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02520284
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Gilead Study Director
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
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
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02520284
Download to PDF