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NCT03046056 · ClinicalTrials.gov registry record · Phase 2

Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)

A Phase 2 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 2
Development phase
78
Enrollment target

NCT03046056: Completed Phase 2 study, sponsored by Gilead Sciences.

NCT03046056 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 78 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03046056, a Phase 2 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 2
Development phase
78 participants
Enrollment target

Study Summary

The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as Crohn's disease activity index (CDAI) \< 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.

Primary Outcome

The CDAI score is used to quantify the symptoms of participants with Crohn's Disease (CD). The score ranges from 0 to 600. Clinical remission by CDAI was defined as a score of \< 150. A higher score indicates more severe disease.

Interventions

  • DRUG Filgotinib
  • DRUG Placebo to match filgotinib

Trial Details

FieldValue
Enrollment Target 78 participants
Start Date 2017-04-11
Est. Completion 2020-07-20
Phase Phase 2
Gilead Sciences

504 total trials

What the finished NCT03046056 record still lists

NCT03046056 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).

The record links to 0 conditions, and to 2 interventions - of which Filgotinib is the first listed.

NCT03046056 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03046056 about?

NCT03046056 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)". The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as Crohn's disease activity index (CDAI) \< 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants will have the option to ...

What is the current status of trial NCT03046056?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2017-04-11. Estimated completion is 2020-07-20.

What interventions are being tested in trial NCT03046056?

The interventions under investigation include: Filgotinib (DRUG), Placebo to match filgotinib (DRUG).

Who is sponsoring clinical trial NCT03046056?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03046056's enrollment target sits among peer trials

78 884th of 2000 higher than 1,110 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 NCT03046056, the US trial registry maintained by the National Library of Medicine. NCT03046056 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.