Clinical trial NCT03201445: Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
Official title: A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Inflammatory Bowel Disease
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
Collaborators: name: Gilead Sciences
First posted: 2017-06-28
Enrollment: 139
Sex: MALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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).

Eligibility criteria: Key Inclusion Criteria:

* Documented diagnosis of ulcerative colitis (UC) or Crohn's Disease (CD) of at least 4 months. Endoscopic and histopathologic documentation of UC or CD.
* Have moderately to severely active UC or CD

Key Exclusion Criteria:

* Previously or currently documented problems with male reproductive health
* 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13
timeFrame: Baseline to Week 13
Secondary outcomes:
measure: Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26
timeFrame: Baseline to Week 26
measure: Change From Baseline in Sperm Total Motility at Week 13
timeFrame: Baseline, Week 13
measure: Change From Baseline in Sperm Total Motility at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Total Sperm Count at Week 13
timeFrame: Baseline, Week 13
measure: Change From Baseline in Total Sperm Count at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Sperm Concentration at Week 13
timeFrame: Baseline, Week 13
measure: Change From Baseline in Sperm Concentration at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Ejaculate Volume at Week 13
timeFrame: Baseline, Week 13
measure: Change From Baseline in Ejaculate Volume at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Percent Normal Sperm Morphology at Week 13
timeFrame: Baseline, Week 13
measure: Change From Baseline in Percent Normal Sperm Morphology at Week 26
timeFrame: Baseline, Week 26
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Lakewood Ranch
country: United States
facility: Florida Research Institute
state: Florida
city: Miami
country: United States
facility: University of Miami Crohn's and Colitis Center
state: Florida
city: Norcross
country: United States
facility: One Health Research Clinic, Inc
state: Georgia
city: Monroe
country: United States
facility: Delta Research Partners
state: Louisiana
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Vienna
country: Austria
facility: AKH Wien - Universitatsklinik fur Innere Medizin III
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Surat
country: India
facility: Surat Institute of Digestive Sciences
state: Gujarat
city: Parel
country: India
facility: Seth GS medical college and KEM hospital
state: Mumbai
city: Ahmedabad
country: India
facility: Kaizen Hospital
city: Bīkaner
country: India
facility: SP Medical college & AG Hospitals
city: Dehli
country: India
facility: Maharaja Agrasen Hospital
city: Hyderabad
country: India
facility: Nizam's Institute of Medical Sciences
city: Jaipur
country: India
facility: SR Kalla Memorial Gastro and General Hospital
city: Jaipur
country: India
facility: SMS Medical College and Hospital
city: Kolhapur
country: India
facility: Om Sai Onco Surgery Center
city: Kolkata
country: India
facility: Institute of Post Graduate Medical Education and Research (IPGMER)
city: Kota
country: India
facility: Radha Krishna Critical Care & General Hospital
city: Ludhiana
country: India
facility: Dayanand Medical College & Hospital
city: Nagpur
country: India
facility: Rahate Surgical Hospital
city: Nagpur
country: India
facility: Crescent Hospital and Heart Centre
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
city: New Delhi
country: India
facility: Batra Hospital and Medical Research Center
city: Rajkot
country: India
facility: Shri Griraj Multispeciality Hospital
city: Secunderabad
country: India
facility: Gandhi Hospital
city: Secunderabad
country: India
facility: Institute of Gastroenterology & Liver Disease, Sunshine Hospitals
city: Surat
country: India
facility: BAPS Pramukh Swami Hospital
city: Vadodara
country: India
facility: Sterling Hospital
city: Varanasi
country: India
facility: Samvedna Hospital
city: Newtown
country: New Zealand
facility: Wellington Hospital
city: Bydgoszcz
country: Poland
facility: Osrodek Badan Klinicznych Cinsante S.C Ewa Galczak-Nowak
city: Kraków
country: Poland
facility: Krakowskie Centrum Medyczne
city: Sopot
country: Poland
facility: Endoskopia Sp.z o.o
city: Warsaw
country: Poland
facility: Bodyclinic Alicja Pasnik
city: Łódź
country: Poland
facility: Santa Familia, Centrum Badan Profilaktyki i Leczenia
city: Timisoara
country: Romania
facility: S.C. Policlinica Dr. Citu S.R.L - Gastroenterologie
city: Moscow
country: Russian Federation
facility: Olla-Med, Llc
city: Penza
country: Russian Federation
facility: State Budgetary Healthcare Institution, Pensa Regional Clinical Hospital n.a N.N Burdenko
city: Rostov-on-Don
country: Russian Federation
facility: State Budgetary Educational Institution of Higher Professional Education "Rostov State Medical University" of the Ministry of Health of Russian Fedn.
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Budgetary Healthcare Institution "City Hospital # 26"
city: Kharkiv
country: Ukraine
facility: Municipal Health Care Institution "Regional Hospital of War Veterans", Therapeutic Department No. 1
city: Kiev
country: Ukraine
facility: Kyiv City Clinical Hospital #18, Proctology Department
city: Vinnitsa
country: Ukraine
facility: Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No. 2
city: Vinnitsya
country: Ukraine
facility: Vinnytsia Regional Clinical Hospital named after M.I. Pirogov, Gastroenterology Department
city: Vinnitsya
country: Ukraine
facility: Medical Center LLC "Health Clinic", Medical Clinical Investigational Center
city: Vinnytsya
country: Ukraine
facility: Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No.1
city: Zaporizhzhya
country: Ukraine
facility: Municupal Institution "Zaporizhzhia City Multidisciplinary Clinic #9" Gastrointestinal Surgery Department,
city: Zaporizhzhya
country: Ukraine
facility: Municipal Non-profit Enterprise "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council,
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
Study officials:
affiliation: Galapagos NV
name: Galapagos Study Director
role: STUDY_DIRECTOR
References:
citation: 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.