Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
NCT ID: NCT03201445
Last Updated: 2024-10-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
139 participants
INTERVENTIONAL
2017-07-11
2023-10-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Filgotinib
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.
Filgotinib
200 mg tablet administered orally once daily
Standard of Care
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.
Placebo
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.
Placebo
Placebo to match filgotinib tablet administered orally once daily
Standard of Care
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.
Interventions
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Filgotinib
200 mg tablet administered orally once daily
Placebo
Placebo to match filgotinib tablet administered orally once daily
Standard of Care
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.
Eligibility Criteria
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Inclusion Criteria
* Have moderately to severely active UC or CD
Exclusion Criteria
* Current use of sulfasalazine or its use within the 26 weeks leading up to Screening; sulfasalazine is not permitted at any point during the study
* Current use of corticosteroids at a dosage of \> 20 mg/day of prednisone or equivalent at randomization
* Indeterminate colitis, ischemic colitis, fulminant colitis, isolated ulcerative proctitis, or toxic mega colon
* Active tuberculosis (TB) or untreated latent tuberculosis
* Use of concomitant prohibited medications as outlined by protocol
21 Years
65 Years
MALE
No
Sponsors
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Gilead Sciences
INDUSTRY
Galapagos NV
INDUSTRY
Responsible Party
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Principal Investigators
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Galapagos Study Director
Role: STUDY_DIRECTOR
Galapagos NV
Locations
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Naval Medical Center San Diego
San Diego, California, United States
Florida Research Institute
Lakewood Rch, Florida, United States
University of Miami Crohn's and Colitis Center
Miami, Florida, United States
One Health Research Clinic, Inc
Norcross, Georgia, United States
Delta Research Partners
Monroe, Louisiana, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Gastro One
Germantown, Tennessee, United States
Texas Clinical Research Institute
Arlington, Texas, United States
Texas Digestive Disease Consultants
Southlake, Texas, United States
Monash Medical Centre
Clayton, Victoria, Australia
AKH Wien - Universitatsklinik fur Innere Medizin III
Vienna, , Austria
Medizinische Hochschule Hannover
Hanover, , Germany
Surat Institute of Digestive Sciences
Surat, Gujarat, India
Seth GS medical college and KEM hospital
Pārel, Mumbai, India
Kaizen Hospital
Ahmedabad, , India
SP Medical college & AG Hospitals
Bīkaner, , India
Maharaja Agrasen Hospital
Dehli, , India
Nizam's Institute of Medical Sciences
Hyderabad, , India
SR Kalla Memorial Gastro and General Hospital
Jaipur, , India
SMS Medical College and Hospital
Jaipur, , India
Om Sai Onco Surgery Center
Kolhāpur, , India
Institute of Post Graduate Medical Education and Research (IPGMER)
Kolkata, , India
Radha Krishna Critical Care & General Hospital
Kota, , India
Dayanand Medical College & Hospital
Ludhiana, , India
Rahate Surgical Hospital
Nagpur, , India
Crescent Hospital and Heart Centre
Nagpur, , India
All India Institute of Medical Sciences
New Delhi, , India
Sir Ganga Ram Hospital
New Delhi, , India
Batra Hospital and Medical Research Center
New Delhi, , India
Shri Griraj Multispeciality Hospital
Rajkot, , India
Gandhi Hospital
Secunderabad, , India
Institute of Gastroenterology & Liver Disease, Sunshine Hospitals
Secunderabad, , India
BAPS Pramukh Swami Hospital
Surat, , India
Sterling Hospital
Vadodara, , India
Samvedna Hospital
Varanasi, , India
Wellington Hospital
Newtown, , New Zealand
Osrodek Badan Klinicznych Cinsante S.C Ewa Galczak-Nowak
Bydgoszcz, , Poland
Krakowskie Centrum Medyczne
Krakow, , Poland
Santa Familia, Centrum Badan Profilaktyki i Leczenia
Lodz, , Poland
Endoskopia Sp.z o.o
Sopot, , Poland
Bodyclinic Alicja Pasnik
Warsaw, , Poland
S.C. Policlinica Dr. Citu S.R.L - Gastroenterologie
Timișoara, , Romania
Olla-Med, Llc
Moscow, , Russia
State Budgetary Healthcare Institution, Pensa Regional Clinical Hospital n.a N.N Burdenko
Penza, , Russia
State Budgetary Educational Institution of Higher Professional Education "Rostov State Medical University" of the Ministry of Health of Russian Fedn.
Rostov-on-Don, , Russia
Saint Petersburg State Budgetary Healthcare Institution "City Hospital # 26"
Saint Petersburg, , Russia
Municipal Health Care Institution "Regional Hospital of War Veterans", Therapeutic Department No. 1
Kharkiv, , Ukraine
Kyiv City Clinical Hospital #18, Proctology Department
Kiev, , Ukraine
Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No. 2
Vinnitsa, , Ukraine
Vinnytsia Regional Clinical Hospital named after M.I. Pirogov, Gastroenterology Department
Vinnitsya, , Ukraine
Medical Center LLC "Health Clinic", Medical Clinical Investigational Center
Vinnitsya, , Ukraine
Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No.1
Vinnytsia, , Ukraine
Municupal Institution "Zaporizhzhia City Multidisciplinary Clinic #9" Gastrointestinal Surgery Department,
Zaporizhzhya, , Ukraine
Municipal Non-profit Enterprise "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council,
Zaporizhzhya, , Ukraine
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-000402-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-418-4279
Identifier Type: -
Identifier Source: org_study_id
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