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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03201445
The ClinicalTrials.gov registry entry for NCT03201445 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 139 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lakefront Biotherapeutics, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03201445 reports 0 study locations.
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.
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