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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
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
Secondary ID [1] 0 0
2014-005217-24
Secondary ID [2] 0 0
GS-US-326-1100
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
For Cohort 1, Percentage of Participants With EBS Clinical Remission at Week 8
Timepoint [1] 0 0
Week 8
Secondary outcome [1] 0 0
For Cohort 1, Percentage of Participants With MCS Remission at Week 8
Timepoint [1] 0 0
Week 8
Secondary outcome [2] 0 0
For Cohort 1, Percentage of Participants With MCS Response at Week 8
Timepoint [2] 0 0
Week 8
Secondary outcome [3] 0 0
For Cohort 1, Percentage of Participants With Endoscopic Remission at Week 8
Timepoint [3] 0 0
Week 8
Secondary outcome [4] 0 0
For Cohort 1, Percentage of Participants With Endoscopic Response at Week 8
Timepoint [4] 0 0
Week 8
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
Timepoint [5] 0 0
Week 8
Secondary outcome [6] 0 0
For Cohort 1, Percentage of Participants With MCS Remission (Alternative Definition) at Week 8
Timepoint [6] 0 0
Week 8

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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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
1/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2016
Sample size
Target
Accrual to date
Final
165
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Footscray
Recruitment hospital [2] 0 0
- Herston
Recruitment hospital [3] 0 0
- Malvern
Recruitment hospital [4] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Footscray
Recruitment postcode(s) [2] 0 0
- Herston
Recruitment postcode(s) [3] 0 0
- Malvern
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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United States of America
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Colorado
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Florida
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Michigan
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Minnesota
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Missouri
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North Carolina
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Ohio
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Tennessee
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Rozzano
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San Giovanni Rotondo
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Oxford
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Prescot

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 Director
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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02520284