NCT03201445Phase 2Terminated

Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel 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 completion2020-11-20Actual

Enrollment · participants139Actual

Source updated2024-10-09Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Inflammatory Bowel Disease

Treatments or interventions studied

FilgotinibDrug
PlaceboDrug
Standard of CareDrug

Primary outcomes · main study measures

Read the study measures

measure: Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13; description: Baseline for sperm/semen parameters was the mean of 2 evaluable semen samples at screening. The normal range for sperm concentration is ≥15 million sperm cells/mL. Percentage change = (\[mean at Week 13 - baseline\] / baseline) × 100; value at Week 13 was the mean of 2 evaluable samples collected at Week 13.; timeFrame: Baseline to Week 13

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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