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NCT03201445 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
A Phase 2 study, sponsored by Lakefront Biotherapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 139
- Enrollment target
NCT03201445: Clinical Trial Phase 2 study, sponsored by Lakefront Biotherapeutics.
NCT03201445 is a Phase 2 study that was terminated before completion, run by Lakefront Biotherapeutics. The registered enrollment target is 139 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.
The verdict
NCT03201445, a Phase 2 study, was terminated before completion, sponsored by Lakefront Biotherapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 139 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the testicular safety of filgotinib in adult males with moderately to severely active inflammatory bowel disease (IBD). Results of this study may be pooled with the results of a separate study being conducted in participants with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis (Protocol GLPG0634-CL-227; NCT03926195) with the same objective. The total planned number of participants in both studies combined will be up to approximately 250 participants.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Standard of Care
- DRUG Filgotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2017-07-11 |
| Est. Completion | 2023-10-24 |
| Phase | Phase 2 |
Why NCT03201445 stopped before completion
NCT03201445 is an interventional study that assigns participants to a tested intervention. The registered 139 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 3 interventions - of which Placebo is the first listed.
NCT03201445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03201445 about?
NCT03201445 is a clinical study titled "Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease". The primary objective of this study is to evaluate the testicular safety of filgotinib in adult males with moderately to severely active inflammatory bowel disease (IBD). Results of this study may be pooled with the results of a separate study being conducted in participants with rheumatoid arthrit...
What is the current status of trial NCT03201445?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 139 participants. The study started on 2017-07-11. Estimated completion is 2023-10-24.
What interventions are being tested in trial NCT03201445?
The interventions under investigation include: Placebo (DRUG), Standard of Care (DRUG), Filgotinib (DRUG).
Who is sponsoring clinical trial NCT03201445?
This trial is sponsored by Lakefront Biotherapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03201445's enrollment target sits among peer trials
139 525th of 2000 higher than 1,476 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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