A Study Of The Safety And Effectiveness Of GS-5745 In Adults With Moderately To Severely Active Ulcerative Colitis
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-006010
NCT ID: NCT02520284
Sponsor Protocol Number: GS-US-326-1100
About this study
This study will evaluate the effectiveness, safety, and tolerability of GS-5745. It will consist of 2 parts: Induction Study (Cohort 1) and Maintenance Study (Cohort 2). Participants in each part will receive either active GS-5745 or a placebo.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- 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)
- Treatment failure with at least one of the following agents received
- Corticosteroids
- Immunomodulators
- Tumor necrosis factor-alpha (TNFα) antagonists
- Vedolizumab
Exclusion Criteria
- Diagnosis of Crohn's disease or indeterminate colitis
- Pregnant or lactating females
- Any chronic medical condition including, but not limited to
- cardiac disease
- pulmonary disease
- alcohol or drug abuse
- Exhibits severe UC with a clinically significant active infection
- History of malignancy in the last 5 years
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Edward Loftus JR, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available