Trial · NCT03201445
Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
NCT03201445, Phase 2, Terminated, Lakefront Biotherapeutics NV; results first posted 2023-12-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease. Trials, record NCT03201445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03201445
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
- NCT number
- NCT03201445
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 139 participants, actual
- Lead sponsor
- Lakefront Biotherapeutics NV
- Conditions
- Inflammatory Bowel Disease
- Interventions
- Filgotinib, Placebo, Standard of Care
- First posted
- 2017-06-28
- Last updated
- 2024-10-09
- Other registries' IDs
- eudract:2017-000402-38
- Results first posted
- 2023-12-06
- Limitations and caveats
- The study was terminated based on the sponsor's decision for reasons other than safety.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13 | Baseline to Week 13 | 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. |
| Secondary | Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26 | Baseline to Week 26 | IBD responder: For ulcerative colitis (UC), a participant who had a reduction of ≥2 in partial Mayo Clinic Score (pMCS) compared with baseline at specified time. For Crohn's disease (CD), a participant who had a reduction of ≥100 points in total Crohn's Disease Activity Index (CDAI) score compared with baseline at specified time. A participant with a baseline total CDAI score of ≥220 to ≤250 was considered an IBD responder if a CDAI score of \<150 was attained at specified time. IBD nonresponder: For UC or CD, a participant who did not fulfil the definition of IBD responder at specified time. pMCS score: Sum of 3 subscores (rectal bleeding, stool frequency, and physician's global assessment) excluding endoscopic subscore; ranging from 0 (none) to 9 (severe disease). CDAI score: A weighted sum of 8 disease activity variables with scores ranging from 0 to over 600, where higher score = higher disease activity. The normal range for sperm concentration is ≥15 million sperm cells/mL. |
| Secondary | Change From Baseline in Sperm Total Motility at Week 13 | Baseline, Week 13 | The normal range for sperm total motility is ≥40%. |
| Secondary | Change From Baseline in Sperm Total Motility at Week 26 | Baseline, Week 26 | IBD responder: For UC, a participant who had a reduction of ≥ 2 in pMCS compared with baseline at specified time. For CD, a participant who had a reduction of ≥ 100 points in total CDAI score compared with baseline at specified time. A participant with a baseline total CDAI score of ≥ 220 to ≤ 250 was considered an IBD responder if a CDAI score of \<150 was attained at specified time. IBD nonresponder: For UC or CD, a participant who did not fulfil the definition of IBD responder at specified time. pMCS score: Sum of 3 subscores (rectal bleeding, stool frequency, and physician's global assessment) excluding endoscopic subscore; ranging from 0 (none) to 9 (severe disease). CDAI score: A weighted sum of 8 disease activity variables with scores ranging from 0 to over 600, where higher score = higher disease activity. The normal range for sperm total motility is ≥40%. |
| Secondary | Change From Baseline in Total Sperm Count at Week 13 | Baseline, Week 13 | The normal range for total sperm count is ≥ 39 million sperm cells/ejaculate. |
| Secondary | Change From Baseline in Total Sperm Count at Week 26 | Baseline, Week 26 | IBD responder: For UC, a participant who had a reduction of ≥ 2 in pMCS compared with baseline at specified time. For CD, a participant who had a reduction of ≥ 100 points in total CDAI score compared with baseline at specified time. A participant with a baseline total CDAI score of ≥ 220 to ≤ 250 was considered an IBD responder if a CDAI score of \<150 was attained at specified time. IBD nonresponder: For UC or CD, a participant who did not fulfil the definition of IBD responder at specified time. pMCS score: Sum of 3 subscores (rectal bleeding, stool frequency, and physician's global assessment) excluding endoscopic subscore; ranging from 0 (none) to 9 (severe disease). CDAI score: A weighted sum of 8 disease activity variables with scores ranging from 0 to over 600, where higher score = higher disease activity. The normal range for total sperm count is ≥ 39 million sperm cells/ejaculate. |
| Secondary | Change From Baseline in Sperm Concentration at Week 13 | Baseline, Week 13 | The normal range for sperm concentration is ≥15 million sperm cells/mL. |
| Secondary | Change From Baseline in Sperm Concentration at Week 26 | Baseline, Week 26 | IBD responder: For UC, a participant who had a reduction of ≥ 2 in pMCS compared with baseline at specified time. For CD, a participant who had a reduction of ≥ 100 points in total CDAI score compared with baseline at specified time. A participant with a baseline total CDAI score of ≥ 220 to ≤ 250 was considered an IBD responder if a CDAI score of \<150 was attained at specified time. IBD nonresponder: For UC or CD, a participant who did not fulfil the definition of IBD responder at specified time. pMCS score: Sum of 3 subscores (rectal bleeding, stool frequency, and physician's global assessment) excluding endoscopic subscore; ranging from 0 (none) to 9 (severe disease). CDAI score: A weighted sum of 8 disease activity variables with scores ranging from 0 to over 600, where higher score = higher disease activity. The normal range for sperm concentration is ≥15 million sperm cells/mL. |
| Secondary | Change From Baseline in Ejaculate Volume at Week 13 | Baseline, Week 13 | The normal range for ejaculate volume is ≥1.5 mL. |
| Secondary | Change From Baseline in Ejaculate Volume at Week 26 | Baseline, Week 26 | IBD responder: For UC, a participant who had a reduction of ≥ 2 in pMCS compared with baseline at specified time. For CD, a participant who had a reduction of ≥ 100 points in total CDAI score compared with baseline at specified time. A participant with a baseline total CDAI score of ≥ 220 to ≤ 250 was considered an IBD responder if a CDAI score of \<150 was attained at specified time. IBD nonresponder: For UC or CD, a participant who did not fulfil the definition of IBD responder at specified time. pMCS score: Sum of 3 subscores (rectal bleeding, stool frequency, and physician's global assessment) excluding endoscopic subscore; ranging from 0 (none) to 9 (severe disease). CDAI score: A weighted sum of 8 disease activity variables with scores ranging from 0 to over 600, where higher score = higher disease activity. The normal range for ejaculate volume is ≥1.5 mL. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13 | Baseline to Week 13 | The Semen Analysis Set included all randomized and treated (≥ 1 dose of double-blind study drug) participants who had 2 semen samples that were eligible for mean calculation at baseline and at the Week 13 analysis visit with the date of the first chronologic semen sample used for purposes of assigning analysis visit windows. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26 | Baseline to Week 26 | Participants in the Week 26 Semen Analysis Set (included all participants who took ≥ 1 dose of study drug and had 2 evaluable samples at baseline and at ≥ 1 postbaseline measurement at/after Week 26 or OL Week 13) with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Sperm Total Motility at Week 13 | Baseline, Week 13 | Participants in the Semen Analysis Set were analyzed. | percentage of motile sperms | MEDIAN |
| SECONDARY | Change From Baseline in Sperm Total Motility at Week 26 | Baseline, Week 26 | Participants in the Week 26 Semen Analysis Set with available data were analyzed. | percentage of motile sperms | MEDIAN |
| SECONDARY | Change From Baseline in Total Sperm Count at Week 13 | Baseline, Week 13 | Participants in the Semen Analysis Set were analyzed. | million sperm cells/ejaculate | MEDIAN |
| SECONDARY | Change From Baseline in Total Sperm Count at Week 26 | Baseline, Week 26 | Participants in the Week 26 Semen Analysis Set with available data were analyzed. | million sperm cells/ejaculate | MEDIAN |
| SECONDARY | Change From Baseline in Sperm Concentration at Week 13 | Baseline, Week 13 | Participants in the Semen Analysis Set were analyzed. | million sperm cells/mL | MEDIAN |
| SECONDARY | Change From Baseline in Sperm Concentration at Week 26 | Baseline, Week 26 | Participants in the Week 26 Semen Analysis Set with available data were analyzed. | million sperm cells/mL | MEDIAN |
| SECONDARY | Change From Baseline in Ejaculate Volume at Week 13 | Baseline, Week 13 | Participants in the Semen Analysis Set were analyzed. | mL | MEDIAN |
| SECONDARY | Change From Baseline in Ejaculate Volume at Week 26 | Baseline, Week 26 | Participants in the Week 26 Semen Analysis Set with available data were analyzed. | mL | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13 | Filgotinib | 1.5 | percentage of participants | ||
| Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13 | Placebo | 9.0 | percentage of participants | ||
| Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26 | Filgotinib/DB Filgotinib (Responder) | 5.0 | percentage of participants | ||
| Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26 | Filgotinib/OL Filgotinib (Nonresponder) | 0 | percentage of participants | ||
| Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26 | Placebo/DB Placebo (Responder) | 7.9 | percentage of participants | ||
| Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26 | Placebo/OL Filgotinib (Nonresponder) | 11.8 | percentage of participants | ||
| Change From Baseline in Sperm Total Motility at Week 13 | Filgotinib | -0.3 | 95% Confidence Interval -1.6 to 1.7 | percentage of motile sperms | |
| Change From Baseline in Sperm Total Motility at Week 13 | Placebo | 0.4 | 95% Confidence Interval -1.3 to 1.5 | percentage of motile sperms | |
| Change From Baseline in Sperm Total Motility at Week 26 | Filgotinib/DB Filgotinib (Responder) | -2.3 | 95% Confidence Interval -4.7 to -0.3 | percentage of motile sperms | |
| Change From Baseline in Sperm Total Motility at Week 26 | Filgotinib/OL Filgotinib (Nonresponder) | -1.5 | 95% Confidence Interval -5.8 to 2.6 | percentage of motile sperms |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A DB Phase (Through Week 13) | STARTED | Filgotinib | 69 | |
| Part A DB Phase (Through Week 13) | STARTED | Placebo | 70 | |
| Part A DB Phase (Through Week 13) | COMPLETED | Filgotinib | 68 | |
| Part A DB Phase (Through Week 13) | COMPLETED | Placebo | 67 | |
| Part A DB Phase (Through Week 13) | NOT COMPLETED | Filgotinib | 1 | |
| Part A DB Phase (Through Week 13) | NOT COMPLETED | Placebo | 3 | |
| Part B DB Phase (Week 13 to 26) | STARTED | Filgotinib | 45 | |
| Part B DB Phase (Week 13 to 26) | STARTED | Placebo | 38 | |
| Part B DB Phase (Week 13 to 26) | COMPLETED | Filgotinib | 42 | |
| Part B DB Phase (Week 13 to 26) | COMPLETED | Placebo | 38 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Colitis ulcerative | Gastrointestinal disorders | Filgotinib | 14 | 92 | |
| other | Colitis ulcerative | Gastrointestinal disorders | Placebo | 3 | 70 | |
| other | Latent tuberculosis | Infections and infestations | Filgotinib | 5 | 92 | |
| other | Latent tuberculosis | Infections and infestations | Placebo | 5 | 70 | |
| other | Nasopharyngitis | Infections and infestations | Filgotinib | 17 | 92 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 3 | 70 | |
| other | COVID-19 | Infections and infestations | Filgotinib | 9 | 92 | |
| other | COVID-19 | Infections and infestations | Placebo | 3 | 70 | |
| other | Abdominal pain | Gastrointestinal disorders | Filgotinib | 3 | 92 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 5 | 70 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Filgotinib | 0 | 92 |
| Total, all-cause mortality | Placebo | 0 | 70 |
| Total, other adverse events | Filgotinib | 47 | 92 |
| Total, other adverse events | Placebo | 24 | 70 |
| Total, serious adverse events | Filgotinib | 3 | 92 |
| Total, serious adverse events | Placebo | 2 | 70 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Filgotinib vs Placebo: deaths from any cause | Trial comparisons |
| Filgotinib vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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