NCT02914600Phase 3Terminated

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

Study sponsor: Lakefront Biotherapeutics NV · LKFT

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-08-01Actual

Enrollment · participants1188Actual

Source updated2024-07-10Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Crohn's Disease

Treatments or interventions studied

FilgotinibDrugAlso known as GS-6034, GLPG0634, Jyseleca®
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs); description: An AE was defined as any untoward medical occurrence in a participant administered a study drug, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. Treatment-emergent adverse events (TEAEs) were defined as 1 or both of the following: * Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug * Any AEs leading to premature discontinuation of study drug.; timeFrame: From the First Dose to Week 312

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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