Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000402-38 | EudraCT Number |
Not provided
Not provided
Early Termination for Reasons other than Safety
Not provided
Not provided
| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
There are 5 parts to the study: 1) Part A: Double-Blind Phase (DB Phase; Day 1 through Week 13); 2) Part B: DB Phase (after Week 13 through Week 26); 3) Open-label (OL) Filgotinib Phase (after Week 13 study visit for up to 13 weeks); 4) Monitoring Phase (MP; up to 52 weeks); and 5) Long-term Extension (LTE) Phase (after Week 26 or end of OL Filgotinib Phase for up to 195 weeks).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filgotinib | Experimental | Participants received filgotinib up to Week 13 in the DB phase (Part A). At Week 13, participants who were IBD responders, without meeting pre-specified sperm decrease thresholds, continued DB treatment up to Week 26 (Part B). Participants who were IBD non-responders at Week 13 or had disease worsening after Week 13 and prior to Week 26, and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib for up to Week 13. At Week 26/OL Week 13, participants who were IBD responders and who had not experienced disease worsening, and whose sperm parameters did not meet a prespecified decrease threshold, continued receiving the same study drug they were responding to as part of the LTE for up to 195 weeks. Participants who met pre-specified sperm decrease threshold(s) at any postbaseline visit discontinued study drug and switched to a standard of care (SOC) regimen selected by the investigator and entered the MP for up to 52 weeks. |
|
| Placebo | Placebo Comparator | Participants received placebo (matched to filgotinib) up to Week 13 in the DB phase (Part A). At Week 13, participants who were IBD responders, without meeting pre-specified sperm decrease thresholds, continued DB treatment up to Week 26 (Part B). Participants who were IBD non-responders at Week 13 or had disease worsening after Week 13 and prior to Week 26, and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib for up to Week 13. At Week 26/OL Week 13, participants who were IBD responders and who had not experienced disease worsening, and whose sperm parameters did not meet a prespecified decrease threshold, continued receiving the same study drug they were responding to as part of the LTE for up to 195 weeks. Participants who met pre-specified sperm decrease threshold(s) at any postbaseline visit discontinued study drug and switched to SOC regimen selected by the investigator and entered the MP for up to 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgotinib | Drug | 200 mg tablet administered orally once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at 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. | Baseline to Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at 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. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Galapagos Study Director | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center San Diego | San Diego | California | 92134 | United States | ||
| Florida Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37137672 | Derived | Reinisch W, Hellstrom W, Dolhain RJEM, Sikka S, Westhovens R, Mehta R, Ritter T, Seidler U, Golovchenko O, Simanenkov V, Garmish O, Jeka S, Moravcova R, Rajendran V, Le Brun FO, Arterburn S, Watkins TR, Besuyen R, Vanderschueren D. Effects of filgotinib on semen parameters and sex hormones in male patients with inflammatory diseases: results from the phase 2, randomised, double-blind, placebo-controlled MANTA and MANTA-RAy studies. Ann Rheum Dis. 2023 Aug;82(8):1049-1058. doi: 10.1136/ard-2023-224017. Epub 2023 May 3. | |
| 35614292 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study had 5 parts: Part A: Double-Blind Phase (DB Phase; Day 1 up to Week 13); Part B: DB Phase (Week 13 up to Week 26); Open-label (OL) Phase (after Week 13 study visit for up to 13 weeks); Monitoring Phase (MP; up to 52 weeks); and Long-term Extension (LTE) Phase (after Week 26 or end of OL Phase for up to 195 weeks).
Participants were enrolled at study sites in Australia, Austria, Germany, India, New Zealand, Poland, Romania, Russian Federation, Ukraine, United Kingdom, and United States. The first participant was screened on 11 July 2017. A total of 323 participants were screened of which 139 participants were randomized into the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Filgotinib | Participants received filgotinib 200 milligrams (mg) tablet, orally, once daily up to Week 13 in the DB phase (Part A). At Week 13, participants who were inflammatory bowel disease (IBD) responders, without meeting pre-specified sperm decrease thresholds, continued DB phase treatment up to Week 26 (Part B). Participants who were IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib 200 mg, tablet, orally, once daily for up to Week 13 during the OL phase. At Week 26/OL Week 13, participants who were IBD responders and who had not experienced disease worsening, and whose sperm parameters did not meet a prespecified decrease threshold, continued receiving the same study drug they were responding to (ie, blinded study drug or OL filgotinib) as part of the LTE for up to 195 weeks. Participants who met pre-specified sperm decrease threshold(s) at any postbaseline visit discontinued study drug and switched to a standard of care (SOC) regimen selected by the investigator (in accordance with the protocol) and entered the MP for up to 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A DB Phase (Through Week 13) |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 9, 2022 | May 22, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo to match filgotinib tablet administered orally once daily |
|
| Standard of Care | Drug | Locally approved treatment, accepted by medical experts as a proper treatment for IBD conditions, prescribed according to best clinical practice, with no known testicular toxicity. |
|
| Baseline to Week 26 |
| Change From Baseline in Sperm Total Motility at Week 13 | The normal range for sperm total motility is ≥40%. | Baseline, Week 13 |
| Change From Baseline in Sperm Total Motility at 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%. | Baseline, Week 26 |
| Change From Baseline in Total Sperm Count at Week 13 | The normal range for total sperm count is ≥ 39 million sperm cells/ejaculate. | Baseline, Week 13 |
| Change From Baseline in Total Sperm Count at 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. | Baseline, Week 26 |
| Change From Baseline in Sperm Concentration at Week 13 | The normal range for sperm concentration is ≥15 million sperm cells/mL. | Baseline, Week 13 |
| Change From Baseline in Sperm Concentration at 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. | Baseline, Week 26 |
| Change From Baseline in Ejaculate Volume at Week 13 | The normal range for ejaculate volume is ≥1.5 mL. | Baseline, Week 13 |
| Change From Baseline in Ejaculate Volume at 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. | Baseline, Week 26 |
| Change From Baseline in Percent Normal Sperm Morphology at Week 13 | The normal range for percent normal sperm morphology is ≥30% normal sperms. | Baseline, Week 13 |
| Change From Baseline in Percent Normal Sperm Morphology at 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 percent normal sperm morphology is ≥30% normal sperms. | Baseline, Week 26 |
| Lakewood Rch |
| Florida |
| 34211 |
| United States |
| University of Miami Crohn's and Colitis Center | Miami | Florida | 33136 | United States |
| One Health Research Clinic, Inc | Norcross | Georgia | 30093 | United States |
| Delta Research Partners | Monroe | Louisiana | 71201 | United States |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | United States |
| Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | 44060 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | United States |
| Texas Digestive Disease Consultants | Southlake | Texas | 76092 | United States |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| AKH Wien - Universitatsklinik fur Innere Medizin III | Vienna | 1090 | Austria |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Surat Institute of Digestive Sciences | Surat | Gujarat | 395002 | India |
| Seth GS medical college and KEM hospital | Pārel | Mumbai | 400012 | India |
| Kaizen Hospital | Ahmedabad | 380052 | India |
| SP Medical college & AG Hospitals | Bīkaner | 334001 | India |
| Maharaja Agrasen Hospital | Dehli | 110026 | India |
| Nizam's Institute of Medical Sciences | Hyderabad | 500082 | India |
| SR Kalla Memorial Gastro and General Hospital | Jaipur | 302001 | India |
| SMS Medical College and Hospital | Jaipur | 302004 | India |
| Om Sai Onco Surgery Center | Kolhāpur | 416006 | India |
| Institute of Post Graduate Medical Education and Research (IPGMER) | Kolkata | 700020 | India |
| Radha Krishna Critical Care & General Hospital | Kota | 324005 | India |
| Dayanand Medical College & Hospital | Ludhiana | 141001 | India |
| Rahate Surgical Hospital | Nagpur | 440008 | India |
| Crescent Hospital and Heart Centre | Nagpur | 440012 | India |
| All India Institute of Medical Sciences | New Delhi | 110029 | India |
| Sir Ganga Ram Hospital | New Delhi | 110060 | India |
| Batra Hospital and Medical Research Center | New Delhi | 110062 | India |
| Shri Griraj Multispeciality Hospital | Rajkot | 360005 | India |
| Gandhi Hospital | Secunderabad | 500003 | India |
| Institute of Gastroenterology & Liver Disease, Sunshine Hospitals | Secunderabad | 50003 | India |
| BAPS Pramukh Swami Hospital | Surat | 395009 | India |
| Sterling Hospital | Vadodara | 390007 | India |
| Samvedna Hospital | Varanasi | 221005 | India |
| Wellington Hospital | Newtown | 6021 | New Zealand |
| Osrodek Badan Klinicznych Cinsante S.C Ewa Galczak-Nowak | Bydgoszcz | 85-079 | Poland |
| Krakowskie Centrum Medyczne | Krakow | 31-501 | Poland |
| Santa Familia, Centrum Badan Profilaktyki i Leczenia | Lodz | 90-302 | Poland |
| Endoskopia Sp.z o.o | Sopot | 81-756 | Poland |
| Bodyclinic Alicja Pasnik | Warsaw | 00-332 | Poland |
| S.C. Policlinica Dr. Citu S.R.L - Gastroenterologie | Timișoara | 300594 | Romania |
| Olla-Med, Llc | Moscow | 105554 | Russia |
| State Budgetary Healthcare Institution, Pensa Regional Clinical Hospital n.a N.N Burdenko | Penza | 440026 | Russia |
| State Budgetary Educational Institution of Higher Professional Education "Rostov State Medical University" of the Ministry of Health of Russian Fedn. | Rostov-on-Don | 344022 | Russia |
| Saint Petersburg State Budgetary Healthcare Institution "City Hospital # 26" | Saint Petersburg | 196247 | Russia |
| Municipal Health Care Institution "Regional Hospital of War Veterans", Therapeutic Department No. 1 | Kharkiv | 61137 | Ukraine |
| Kyiv City Clinical Hospital #18, Proctology Department | Kiev | 01030 | Ukraine |
| Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No. 2 | Vinnitsa | 21018 | Ukraine |
| Vinnytsia Regional Clinical Hospital named after M.I. Pirogov, Gastroenterology Department | Vinnitsya | 21018 | Ukraine |
| Medical Center LLC "Health Clinic", Medical Clinical Investigational Center | Vinnitsya | 21029 | Ukraine |
| Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No.1 | Vinnytsia | 21018 | Ukraine |
| Municupal Institution "Zaporizhzhia City Multidisciplinary Clinic #9" Gastrointestinal Surgery Department, | Zaporizhzhya | 69096 | Ukraine |
| Municipal Non-profit Enterprise "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council, | Zaporizhzhya | 69600 | Ukraine |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | CB2 0QQ | United Kingdom |
| Derived |
| Hellstrom WJG, Dolhain RJEM, Ritter TE, Watkins TR, Arterburn SJ, Dekkers G, Gillen A, Tonussi C, Gilles L, Oortwijn A, Van Beneden K, de Vries DE, Sikka SC, Vanderschueren D, Reinisch W. MANTA and MANTA-RAy: Rationale and Design of Trials Evaluating Effects of Filgotinib on Semen Parameters in Patients with Inflammatory Diseases. Adv Ther. 2022 Jul;39(7):3403-3422. doi: 10.1007/s12325-022-02168-4. Epub 2022 May 25. |
| FG001 | Placebo | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase (Part A). At Week 13, participants who were IBD responders, without meeting pre-specified sperm decrease thresholds, continued DB phase treatment up to Week 26 (Part B). Participants who were IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib 200 mg, tablet, orally, once daily for up to Week 13 during the OL phase. At Week 26/OL Week 13, participants who were IBD responders and who had not experienced disease worsening, and whose sperm parameters did not meet a prespecified decrease threshold, continued receiving the same study drug they were responding to (ie, blinded study drug or OL filgotinib) as part of the LTE for up to 195 weeks. Participants who met pre-specified sperm decrease threshold(s) at any postbaseline visit discontinued study drug and switched to SOC regimen selected by the investigator (in accordance with the protocol) and entered the MP for up to 52 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part B DB Phase (Week 13 to 26) |
|
|
| OL Phase (13 Weeks) |
|
|
| LTE: DB Study Drug (up to Week 195) |
|
|
| LTE: OL Study Drug (Up to Week 195) |
|
|
| Monitoring Phase (Up to Week 52) |
|
|
The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Filgotinib | Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase (Part A). At Week 13, participants who were IBD responders, without meeting pre-specified sperm decrease thresholds, continued DB phase treatment up to Week 26 (Part B). Participants who were IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib 200 mg, tablet, orally, once daily for up to Week 13 during the OL phase. At Week 26/OL Week 13, participants who were IBD responders and who had not experienced disease worsening, and whose sperm parameters did not meet a prespecified decrease threshold, continued receiving the same study drug they were responding to (ie, blinded study drug or OL filgotinib) as part of the LTE for up to 195 weeks. Participants who met pre-specified sperm decrease threshold(s) at any postbaseline visit discontinued study drug and switched to a SOC regimen selected by the investigator (in accordance with the protocol) and entered the MP for up to 52 weeks. |
| BG001 | Placebo | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase (Part A). At Week 13, participants who were IBD responders, without meeting pre-specified sperm decrease thresholds, continued DB phase treatment up to Week 26 (Part B). Participants who were IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib 200 mg, tablet, orally, once daily for up to Week 13 during the OL phase. At Week 26/OL Week 13, participants who were IBD responders and who had not experienced disease worsening, and whose sperm parameters did not meet a prespecified decrease threshold, continued receiving the same study drug they were responding to (ie, blinded study drug or OL filgotinib) as part of the LTE for up to 195 weeks. Participants who met pre-specified sperm decrease threshold(s) at any postbaseline visit discontinued study drug and switched to SOC regimen selected by the investigator (in accordance with the protocol) and entered the MP for up to 52 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Not Permitted = local regulators did not allow collection of race or ethnicity information. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Not Permitted = local regulators did not allow collection of race or ethnicity information. | Count of Participants | Participants |
| |||||||||||||||
| Sperm Concentration | Mean | Standard Deviation | million sperm cells/milliliter (mL) |
| |||||||||||||||
| Total Sperm Count | Mean | Standard Deviation | million sperm cells/ejaculate |
| |||||||||||||||
| Sperm Total Motility | Mean | Standard Deviation | percentage of motile sperm |
| |||||||||||||||
| Ejaculate Volume | Mean | Standard Deviation | mL |
| |||||||||||||||
| Percent Normal Sperm Morphology | Mean | Standard Deviation | percentage of normal sperm |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at 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. | 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. | Posted | Number | percentage of participants | Baseline to Week 13 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at 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. | 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. | Posted | Number | percentage of participants | Baseline to Week 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Sperm Total Motility at Week 13 | The normal range for sperm total motility is ≥40%. | Participants in the Semen Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | percentage of motile sperms | Baseline, Week 13 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Sperm Total Motility at 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%. | Participants in the Week 26 Semen Analysis Set with available data were analyzed. | Posted | Median | 95% Confidence Interval | percentage of motile sperms | Baseline, Week 26 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Sperm Count at Week 13 | The normal range for total sperm count is ≥ 39 million sperm cells/ejaculate. | Participants in the Semen Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | million sperm cells/ejaculate | Baseline, Week 13 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Sperm Count at 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. | Participants in the Week 26 Semen Analysis Set with available data were analyzed. | Posted | Median | 95% Confidence Interval | million sperm cells/ejaculate | Baseline, Week 26 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Sperm Concentration at Week 13 | The normal range for sperm concentration is ≥15 million sperm cells/mL. | Participants in the Semen Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | million sperm cells/mL | Baseline, Week 13 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Sperm Concentration at 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. | Participants in the Week 26 Semen Analysis Set with available data were analyzed. | Posted | Median | 95% Confidence Interval | million sperm cells/mL | Baseline, Week 26 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Ejaculate Volume at Week 13 | The normal range for ejaculate volume is ≥1.5 mL. | Participants in the Semen Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | mL | Baseline, Week 13 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Ejaculate Volume at 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. | Participants in the Week 26 Semen Analysis Set with available data were analyzed. | Posted | Median | 95% Confidence Interval | mL | Baseline, Week 26 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Percent Normal Sperm Morphology at Week 13 | The normal range for percent normal sperm morphology is ≥30% normal sperms. | Participants in the Semen Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | percentage of normal sperms | Baseline, Week 13 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Percent Normal Sperm Morphology at 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 percent normal sperm morphology is ≥30% normal sperms. | Participants in the Week 26 Semen Analysis Set with available data were analyzed. | Posted | Median | 95% Confidence Interval | percentage of normal sperms | Baseline, Week 26 |
|
From first dose up to Week 226
All on-treatment safety data during the study were reported under the treatment received at the onset of the event (As-treated set).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Filgotinib | Participants received filgotinib 200 mg tablet, orally once daily (OD) up to Week 13 in DB phase (Part A). At Week 13, IBD responders, without meeting pre-specified sperm decrease thresholds, continued DB phase treatment up to Week 26 (Part B). IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet prespecified decrease threshold, entered the OL Phase, and received OL filgotinib 200 mg, tablet orally OD for up to Week 13 during the OL phase. At Week 26/OL Week 13, IBD responders and who had not experienced disease worsening, and whose sperm parameters did not meet prespecified decrease threshold, continued receiving the same study drug they were responding to, as part of LTE for up to 195 weeks. Participants who met prespecified sperm decrease threshold(s) discontinued study drug and switched to SOC regimen selected by investigator and entered the MP for up to 52 weeks. | 0 | 92 | 3 | 92 | 47 | 92 |
| EG001 | Placebo | Participants received placebo (matched to filgotinib) tablet, orally OD up to Week 13 in DB phase (Part A). At Week 13, IBD responders, without meeting pre-specified sperm decrease thresholds, continued DB phase treatment up to Week 26 (Part B). IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet prespecified decrease threshold, entered the OL Phase, and received OL filgotinib 200 mg, tablet orally OD for up to Week 13 during the OL phase. At Week 26/OL Week 13, IBD responders and who had not experienced disease worsening, and whose sperm parameters did not meet prespecified decrease threshold, continued receiving the same study drug they were responding to, as part of LTE for up to 195 weeks. Participants who met prespecified sperm decrease threshold(s) discontinued study drug and switched to SOC regimen selected by investigator and entered the MP for up to 52 weeks. | 0 | 70 | 2 | 70 | 24 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
The study was terminated based on the sponsor's decision for reasons other than safety.
The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Galapagos Medical Information | Galapagos NV | +32 15 342 900 | medicalinfo@glpg.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 13, 2021 | May 26, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C584571 | GLPG0634 |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| Physician Decision |
|
| Withdrawal by Subject |
|
| Pre-Specified Decrease In Sperm Parameters (Switched to MP) |
|
| Study Terminated By Sponsor |
|
| Withdrawal by Subject |
|
| Pre-Specified Decrease In Sperm Parameters (Switched to MP) |
|
| Progressive Disease |
|
| Study Terminated By Sponsor |
|
| Male |
|
| Hispanic or Latino |
|
| Not Permitted |
|
| Asian |
|
| Black or African American |
|
| White |
|
| Not Permitted |
|
| OG001 | Filgotinib/OL Filgotinib (Nonresponder) | Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase (Part A). Participants who were IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib 200 mg, tablet, orally, once daily for up to Week 13 during the OL phase. |
| OG002 | Placebo/DB Placebo (Responder) | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase (Part A). At Week 13, participants who were IBD responders, without meeting pre-specified sperm decrease thresholds, continued DB phase treatment up to Week 26 (Part B). |
| OG003 | Placebo/OL Filgotinib (Nonresponder) | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase (Part A). Participants who were IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib 200 mg, tablet, orally, once daily for up to Week 13 during the OL phase. |
|
|
|
|
Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase (Part A). Participants who were IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib 200 mg, tablet, orally, once daily for up to Week 13 during the OL phase.
| OG002 | Placebo/DB Placebo (Responder) | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase (Part A). At Week 13, participants who were IBD responders, without meeting pre-specified sperm decrease thresholds, continued DB phase treatment up to Week 26 (Part B). |
| OG003 | Placebo/OL Filgotinib (Nonresponder) | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase (Part A). Participants who were IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib 200 mg, tablet, orally, once daily for up to Week 13 during the OL phase. |
|
|
|
|
Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase (Part A). Participants who were IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib 200 mg, tablet, orally, once daily for up to Week 13 during the OL phase. |
| OG002 | Placebo/DB Placebo (Responder) | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase (Part A). At Week 13, participants who were IBD responders, without meeting pre-specified sperm decrease thresholds, continued DB phase treatment up to Week 26 (Part B). |
| OG003 | Placebo/OL Filgotinib (Nonresponder) | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase (Part A). Participants who were IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib 200 mg, tablet, orally, once daily for up to Week 13 during the OL phase. |
|
|
|
|
Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase (Part A). Participants who were IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib 200 mg, tablet, orally, once daily for up to Week 13 during the OL phase.
| OG002 | Placebo/DB Placebo (Responder) | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase (Part A). At Week 13, participants who were IBD responders, without meeting pre-specified sperm decrease thresholds, continued DB phase treatment up to Week 26 (Part B). |
| OG003 | Placebo/OL Filgotinib (Nonresponder) | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase (Part A). Participants who were IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib 200 mg, tablet, orally, once daily for up to Week 13 during the OL phase. |
|
|
|
|
Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase (Part A). Participants who were IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib 200 mg, tablet, orally, once daily for up to Week 13 during the OL phase.
| OG002 | Placebo/DB Placebo (Responder) | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase (Part A). At Week 13, participants who were IBD responders, without meeting pre-specified sperm decrease thresholds, continued DB phase treatment up to Week 26 (Part B). |
| OG003 | Placebo/OL Filgotinib (Nonresponder) | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase (Part A). Participants who were IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib 200 mg, tablet, orally, once daily for up to Week 13 during the OL phase. |
|
|
|
|
Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase (Part A). Participants who were IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib 200 mg, tablet, orally, once daily for up to Week 13 during the OL phase. |
| OG002 | Placebo/DB Placebo (Responder) | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase (Part A). At Week 13, participants who were IBD responders, without meeting pre-specified sperm decrease thresholds, continued DB phase treatment up to Week 26 (Part B). |
| OG003 | Placebo/OL Filgotinib (Nonresponder) | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase (Part A). Participants who were IBD non-responders at Week 13 (end of Part A) or had disease worsening after Week 13 and prior to Week 26 (in Part B), and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib 200 mg, tablet, orally, once daily for up to Week 13 during the OL phase. |
|
|