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NCT02520284 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Andecaliximab (GS-5745) in Adults With Moderately to Severely Active Ulcerative Colitis
A Phase 2 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 165
- Enrollment target
NCT02520284 is a Phase 2 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 165 participants.
The verdict
NCT02520284, a Phase 2 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 165 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Andecaliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2015-09 |
| Est. Completion | 2016-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02520284
The ClinicalTrials.gov registry entry for NCT02520284 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 165 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02520284 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02520284 about?
NCT02520284 is a clinical study titled "Safety and Efficacy of Andecaliximab (GS-5745) in Adults With Moderately to Severely Active Ulcerative Colitis". 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 (Cohor...
What is the current status of trial NCT02520284?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 165 participants. The study started on 2015-09. Estimated completion is 2016-11.
What interventions are being tested in trial NCT02520284?
The interventions under investigation include: Placebo (BIOLOGICAL), Andecaliximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02520284?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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