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Filgotinib in Long-Term Exten...

Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease

Last Updated: 2024-07-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-17

Study Completion Date

2023-08-01

Brief Summary

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The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in Crohn's disease (CD).

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Participants received blinded treatment during different phases in the study.

Study Groups

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Filgotinib 200 mg

Participants who received filgotinib 200 milligrams (mg) blinded and completed the parent study, continued to receive filgotinib 200 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 200 mg.

Participants who exited the parent study due to disease worsening or failure to meet response or remission criteria, with the exception of US and Korean males who were not considered dual-biologic refractory, received filgotinib 200 mg open-label in this study.

Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).

Group Type EXPERIMENTAL