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NCT02405442 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease
A Phase 2 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 187
- Enrollment target
NCT02405442: Clinical Trial Phase 2 study, sponsored by Gilead Sciences.
NCT02405442 is a Phase 2 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 187 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02405442, a Phase 2 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 187 participants
- Enrollment target
Study Summary
This study will primarily evaluate the safety and efficacy of andecaliximab in adults with active Crohn's disease. The study will consist of a Double-Blind Phase of 8 weeks followed by an Open-Label Extension. Participants who complete the Double-Blind Phase will be eligible to enroll in the optional Open-Label Extension for an additional 44 weeks. Participants who complete Week 52 assessments will be eligible to enter the Extended Treatment Phase to continue treatment with andecaliximab for an additional 156 weeks.
Primary Outcome
Clinical response was defined as patient-reported outcomes (PRO2) score ≤ 8 at Week 8. PRO2 is the weighted average of the 2 variables of frequency of liquid or very soft stool and abdominal pain, based on 7-day participant diary data. The PRO2 score has a minimum score of 0 and has no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants w
Interventions
- DRUG Placebo
- DRUG Andecaliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2015-04-30 |
| Est. Completion | 2016-12-22 |
| Phase | Phase 2 |
Why NCT02405442 stopped before completion
NCT02405442 is an interventional study that assigns participants to a tested intervention. The registered 187 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 (41% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02405442 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02405442 about?
NCT02405442 is a clinical study titled "Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease". This study will primarily evaluate the safety and efficacy of andecaliximab in adults with active Crohn's disease. The study will consist of a Double-Blind Phase of 8 weeks followed by an Open-Label Extension. Participants who complete the Double-Blind Phase will be eligible to enroll in the optiona...
What is the current status of trial NCT02405442?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 187 participants. The study started on 2015-04-30. Estimated completion is 2016-12-22.
What interventions are being tested in trial NCT02405442?
The interventions under investigation include: Placebo (DRUG), Andecaliximab (DRUG).
Who is sponsoring clinical trial NCT02405442?
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 NCT02405442's enrollment target sits among peer trials
187 357th of 2000 higher than 1,644 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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