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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: Clinical Trial Phase 2 study, sponsored by Gilead Sciences.
NCT02520284 is a Phase 2 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 165 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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 stool
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Andecaliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2015-09 |
| Est. Completion | 2016-11 |
| Phase | Phase 2 |
Why NCT02520284 stopped before completion
NCT02520284 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02520284 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02520284's enrollment target sits among peer trials
165 410th of 2000 higher than 1,588 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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