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NCT01461317 · ClinicalTrials.gov registry record · Phase 2

Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis

A Phase 2 study, sponsored by Genentech.

Completed
Registry status
Phase 2
Development phase
121
Enrollment target

NCT01461317: Completed Phase 2 study, sponsored by Genentech.

NCT01461317 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 121 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01461317, a Phase 2 study, has completed, sponsored by Genentech.

COMPLETED
Registry status
Phase 2
Development phase
121 participants
Enrollment target

Study Summary

This study is an open-label extension (OLE) trial to evaluate the safety and tolerability of etrolizumab in participants with moderate to severe ulcerative colitis (UC) who were enrolled in the Phase II Study ABS4986g (NCT01336465) and meet the eligibility criteria for entry in the OLE study.

Interventions

  • DRUG Etrolizumab

Trial Details

FieldValue
Enrollment Target 121 participants
Start Date 2011-11-29
Est. Completion 2016-08-07
Phase Phase 2
Genentech

332 total trials

What the finished NCT01461317 record still lists

NCT01461317 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which Etrolizumab is the first listed.

NCT01461317 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01461317 about?

NCT01461317 is a clinical study titled "Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis". This study is an open-label extension (OLE) trial to evaluate the safety and tolerability of etrolizumab in participants with moderate to severe ulcerative colitis (UC) who were enrolled in the Phase II Study ABS4986g (NCT01336465) and meet the eligibility criteria for entry in the OLE study.

What is the current status of trial NCT01461317?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 121 participants. The study started on 2011-11-29. Estimated completion is 2016-08-07.

What interventions are being tested in trial NCT01461317?

The interventions under investigation include: Etrolizumab (DRUG).

Who is sponsoring clinical trial NCT01461317?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01461317's enrollment target sits among peer trials

121 567th of 2000 higher than 1,432 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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Source: ClinicalTrials.gov NCT01461317, the US trial registry maintained by the National Library of Medicine. NCT01461317 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.