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Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease (MANTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03201445
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

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.

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.


Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Drug: Filgotinib Drug: Placebo Drug: Standard of Care Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 11, 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : October 2024

Arm Intervention/treatment
Experimental: Part A and Part B (Filgotinib or Placebo)
Participants will receive double-blind filgotinib or placebo for 13 weeks in Part A. Based on inflammatory bowel disease response status and sperm parameters, participants will continue on the blinded treatment for up to an additional 13 weeks in Part B or discontinue blinded study drug and commence open-label filgotinib.
Drug: Filgotinib
200 mg tablet administered orally once daily

Drug: Placebo
Tablet administered orally once daily

Experimental: Open-Label Filgotinib Phase
Participants will receive open-label filgotinib for up to 13 weeks.
Drug: Filgotinib
200 mg tablet administered orally once daily

Experimental: Monitoring Phase
Participants whose sperm parameters meet a pre- specified decrease threshold at any time during the study, regardless of inflammatory bowel disease response status, will discontinue study drug and receive standard of care therapy in the Monitoring Phase.
Drug: Standard of Care
Standard of care therapy

Experimental: Long Term Extension Phase
Participants qualifying to enter the Long Term Extension Phase will receive either open-label filgotinib or blinded study drug for up to 195 weeks based on the individual's response criteria.
Drug: Filgotinib
200 mg tablet administered orally once daily

Drug: Placebo
Tablet administered orally once daily




Primary Outcome Measures :
  1. Proportion of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13 [ Time Frame: Week 13 ]

Secondary Outcome Measures :
  1. Proportion of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26 [ Time Frame: Week 26 ]
  2. Change From Baseline in Percent Motile Sperm at Week 13 [ Time Frame: Week 13 ]
  3. Change From Baseline in Percent Motile Sperm at Week 26 [ Time Frame: Week 26 ]
  4. Change From Baseline in Total Sperm Count at Week 13 [ Time Frame: Week 13 ]
  5. Change From Baseline in Total Sperm Count at Week 26 [ Time Frame: Week 26 ]
  6. Change From Baseline in Sperm Concentration at Week 13 [ Time Frame: Week 13 ]
  7. Change From Baseline in Sperm Concentration at Week 26 [ Time Frame: Week 26 ]
  8. Change from Baseline in Ejaculate Volume at Week 13 [ Time Frame: Week 13 ]
  9. Change from Baseline in Ejaculate Volume at Week 26 [ Time Frame: Week 26 ]
  10. Change from Baseline in Percent Normal Sperm Morphology at Week 13 [ Time Frame: Week 13 ]
  11. Change from Baseline in Percent Normal Sperm Morphology at Week 26 [ Time Frame: Week 26 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male participants who are between the ages of 21 and 65 (inclusive) on the day of signing informed consent
  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201445


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

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Locations
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United States, California
Naval Medical Center San Diego Active, not recruiting
San Diego, California, United States, 92134
Clearview Medical Research, LLC Recruiting
Santa Clarita, California, United States, 91351
United States, Florida
Nirvana Research Center Recruiting
Doral, Florida, United States, 33166
Universal Axon Clinical Research Recruiting
Doral, Florida, United States, 33166
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Florida Research Institute Active, not recruiting
Lakewood Ranch, Florida, United States, 34211
University of Miami Crohn's and Colitis Center Recruiting
Miami, Florida, United States, 33136
L&C Professional Medical Research Institute Withdrawn
Miami, Florida, United States, 33144
Medical Research Center Recruiting
Miami, Florida, United States, 33144
Gastroenterology Group of Naples Recruiting
Naples, Florida, United States, 34102
Avail Clinical Research, LLC Recruiting
Orange City, Florida, United States, 32763
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Florida Medical Clinic, PA Recruiting
Zephyrhills, Florida, United States, 33542
United States, Georgia
Gastroenterology Associates Of Central Georgia, LLC Recruiting
Macon, Georgia, United States, 31201
One Health Research Clinic, Inc Recruiting
Norcross, Georgia, United States, 30093
United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
United States, Louisiana
Delta Research Partners Active, not recruiting
Monroe, Louisiana, United States, 71201
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Louisiana Research Center Recruiting
Shreveport, Louisiana, United States, 71105
United States, Maryland
Investigative Clinical Research Withdrawn
Annapolis, Maryland, United States, 21401
Gastro Center of Maryland Recruiting
Columbia, Maryland, United States, 21045
United States, Michigan
Clinical Research Institute of Michigan, LLC Recruiting
Chesterfield, Michigan, United States, 48047
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
United States, North Dakota
Fargo Gastroenterology and Hepatology Clinic Recruiting
Fargo, North Dakota, United States, 58103
United States, Ohio
Dayton Gastroenterology, Inc Recruiting
Beavercreek, Ohio, United States, 45440
Consultants for Clinical Research Completed
Cincinnati, Ohio, United States, 45219
Great Lakes Gastroenterology Research, LLC Recruiting
Mentor, Ohio, United States, 44060
Paramount Medical Research & Consulting, LLC Recruiting
Middleburg Heights, Ohio, United States, 44130
United States, Pennsylvania
Frontier Clinical Research, LLC Recruiting
Smithfield, Pennsylvania, United States, 15478
Digestive Disease Associates, LTD Recruiting
Wyomissing, Pennsylvania, United States, 19610
United States, Tennessee
Gastro One Active, not recruiting
Germantown, Tennessee, United States, 38138
Vanderbilt University Medical Center-IBD Clinic Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Clinical Research Institute Recruiting
Arlington, Texas, United States, 76012
Pinnacle Clinical Research Recruiting
Austin, Texas, United States, 78745
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Pinnacle Clinical Research Recruiting
Live Oak, Texas, United States, 78233
DHAT Research Institute Recruiting
Richardson, Texas, United States, 75082
Gastroenterology Research of San Antonio Recruiting
San Antonio, Texas, United States, 78229
Texas Digestive Disease Consultants Recruiting
San Marcos, Texas, United States, 78130
Texas Digestive Disease Consultants Recruiting
Southlake, Texas, United States, 76092
Spring Gastroenterology Recruiting
Spring, Texas, United States, 77386
United States, Utah
Val R. Hansen, M.D. Recruiting
Bountiful, Utah, United States, 84010
Clinical Research Advantage, Inc. / Wasatch Peak Family Practice Recruiting
Layton, Utah, United States, 84041
United States, Virginia
Gastroenterology Associates Of Tidewater Recruiting
Chesapeake, Virginia, United States, 23320
Emeritas Research Group Withdrawn
Lansdowne Town Center, Virginia, United States, 20176
McGuire DVAMC Recruiting
Richmond, Virginia, United States, 23249
Australia, Victoria
Monash Medical Centre Recruiting
Clayton, Victoria, Australia, 3168
Australia
Princess Alexandra Hospital Recruiting
Woolloongabba, Australia, 4102
Austria
AKH Wien - Universitatsklinik fur Innere Medizin III Recruiting
Vienna, Austria, 1090
Belgium
Algemeen Ziekenhuis Sint-Maarten Recruiting
Mechelen, Belgium, 2800
Canada
Discovery Clinical Services Ltd. Recruiting
Victoria, Canada, V8T 5G4
Czechia
G.E.P Clinics, s r.o Recruiting
Praha, Czechia, 130 00
Germany
DRK Kliniken Berlin Westend Withdrawn
Berlin, Germany, 14050
CED Studien UG, Internationales Crohn Colitis Centrum (ICCC) Rhein-Main Recruiting
Frankfurt, Germany, 60954
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Universitatsklinikum Ulm Recruiting
Ulm, Germany, 89081
India
Surat Institute of Digestive Sciences Recruiting
Surat, Gujarat, India, 395002
Seth GS medical college and KEM hospital Recruiting
Parel, Mumbai, India, 400012
Kaizen Hospital Recruiting
Ahmedabad, India, 380052
Raj Jindal Super Speciality Hospital Not yet recruiting
Bharatpur, India, 321001
SP Medical college & AG Hospitals Recruiting
Bīkaner, India, 334001
Apollo Specialty Hospital Recruiting
Chennai, India, 600035
Maharaja Agrasen Hospital Recruiting
Dehli, India, 110026
Fortis Memorial research Institute Recruiting
Gurgaon, India, 122002
Nizam's Institute of Medical Sciences Recruiting
Hyderabad, India, 500082
SR Kalla Memorial Gastro and General Hospital Recruiting
Jaipur, India, 302001
SMS Medical College and Hospital Recruiting
Jaipur, India, 302004
Rukmani Birla Hospital, A Unit of CMRI Not yet recruiting
Jaipur, India, 302018
Institute of Post Graduate Medical Education and Research (IPGMER) Recruiting
Kolkata, India, 700020
Radha Krishna Critical Care & General Hospital Recruiting
Kota, India, 324005
Dayanand Medical College & Hospital Recruiting
Ludhiana, India, 141001
Apollo Speciality Hospital Recruiting
Madurai, India, 625020
Kasturba Medical College (KCM) Hospital Recruiting
Mangalore, India, 575001
Rahate Surgical Hospital Recruiting
Nagpur, India, 440008
Crescent Hospital and Heart Centre Recruiting
Nagpur, India, 440012
All India Institute of Medical Sciences Recruiting
New Delhi, India, 110029
Sir Ganga Ram Hospital Recruiting
New Delhi, India, 110060
Batra Hospital and Medical Research Center Recruiting
New Delhi, India, 110062
Grant Medical Foundation Ruby Hall Clinic Recruiting
Pune, India, 411001
MTES'S Sanjeevan Hospital Recruiting
Pune, India, 411004
Niramaya Hospital Recruiting
Pune, India, 411019
Shri Griraj Multispeciality Hospital Recruiting
Rajkot, India, 360002
Gandhi Hospital Recruiting
Secunderabad, India, 500003
Institute of Gastroenterology & Liver Disease, Sunshine Hospitals Recruiting
Secunderabad, India, 50003
Kasturba Medical College Hospital Recruiting
Udupi, India, 576104
Sterling Hospital Recruiting
Vadodara, India, 390007
Samvedana Hospital Recruiting
Varanasi, India, 221005
Netherlands
Nij Smellinghe Hospital Recruiting
Drachten, Netherlands, 9202 NN
Erasmus Medical Center Recruiting
Rotterdam, Netherlands, 3015 CE
New Zealand
Wellington Hospital Recruiting
Newtown, New Zealand, 6021
Poland
Medical concierge centrum medyczne Recruiting
Warszawa, Mazowieckie, Poland, 02-798
Osrodek Badan Klinicznych Cinsante S.C Ewa Galczak-Nowak Recruiting
Bydgoszcz, Poland, 85-079
NZOZ Inter-Med Recruiting
Czestochowa, Poland, 42-217
Krakowskie Centrum Medyczne Recruiting
Kraków, Poland, 31-501
Clinical Research Center Sp. zo.o Medic-R Sp. k. Recruiting
Poznan, Poland, 60-856
Endoskopia Sp.z o.o Recruiting
Sopot, Poland, 81-756
Twoja Przychodnia Szczecinskie Centrum Medyczne Recruiting
Szczecin, Poland, 70-361
H-T Centrum Medyczne - Endoterapia Recruiting
Tychy, Poland, 43-100
Bodyclinic Alicja Pasnik Not yet recruiting
Warsaw, Poland, 00-332
Centrum Zdrowia MDM Recruiting
Warszawa, Poland, 0-635
Centrum Badawcze Wspolczesnej Terapii, Prywatny Gabinet Lekarski Dr Anna Bochenek-Mularczyk Recruiting
Warszawa, Poland, 02-679
Niepubliczny Zaklad Opieka Zdrowotnej VIVAMED Jadwiga Miecz Recruiting
Warszawa, Poland, 03-580
Centrum Medyczne- Omni Clinic Sp. z o.o. Sp.k. Recruiting
Wroclaw, Poland, 50-449
Santa Familia, Centrum Badan Profilaktyki i Leczenia Recruiting
Łódź, Poland, 90-302
Portugal
Hospital Lusiadas Lisboa Recruiting
Lisboa, Portugal, 1500-458
Unidade Local de Saude do Alto Minho, EPE Recruiting
Viana do Castelo, Portugal, 4904-858
Romania
Spitalul Universitar de Urgenta Bucuresti- Sectia Medicina Interna II Active, not recruiting
Bucharest, Romania, 50098
S.C. MedLife S.A.,Gastroenterologie Active, not recruiting
Bucuresti, Romania, 10719
S.C. Policlinica Dr. Citu S.R.L - Gastroenterologie Recruiting
Timisoara, Romania, 300594
Russian Federation
State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Hospital" Recruiting
Chelyabinsk, Russian Federation, 454076
Federal State Budgetary Healthcare Institution Hospital Irkutsk Scientific Center of the Siberian Branch of the Russian Academy of Sciences Recruiting
Irkutsk, Russian Federation, 664079
Clinic of the Kuban State Medical University Recruiting
Krasnodar, Russian Federation, 350063
Olla-Med, Llc Recruiting
Moscow, Russian Federation, 105554
State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow" Recruiting
Moscow, Russian Federation, 127015
Municipal Budgetary Healthcare Institution "Clinical Diagnostics Centre "Zdorovye" in Rostov-on-Don" Recruiting
Rostov-on-Don, Russian Federation, 344011
State Budgetary Educational Institution of Higher Professional Education "Rostov State Medical University" of the Ministry of Health of Russian Fedn. Recruiting
Rostov-on-Don, Russian Federation, 344022
Saint Petersburg State Budgetary Healthcare Institution "City Hospital # 26" Recruiting
Saint Petersburg, Russian Federation, 196247
Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC Recruiting
Smolensk, Russian Federation, 214019
Saint Petersburg State Budgetary Healthcare Institution "City Hospital of the Holy Martyr Elizabeth" Recruiting
St. Petersburg, Russian Federation, 195257
Spain
Hospital Universitario de Gran Canaria "Dr. Negrin" Not yet recruiting
Las Palmas De Gran Canaria, Spain, 35020
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Sweden
Akademiska Sjukhuset Recruiting
Uppsala, Sweden, 75185
Taiwan
Changhua Christian Hospital Recruiting
Chang Hua, Taiwan, 500
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan, 807
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
MacKay Memorial Hospital Recruiting
Taipei, Taiwan, 10449
Tri-Service General Hospital Recruiting
Taipei, Taiwan, 114
Ukraine
Municipal City Clinical Hospital of the Emergency Medical Care, 1st Therapeutics Department, Danylo Halytsky Lviv National Medical Recruiting
Chernivtsi, Ukraine, 58000
Kharkiv Medical Academy of Post-graduate Education of MOH of Ukraine Recruiting
Kharkiv, Ukraine, 61137
Kyiv City Clinical Hospital #18, Proctology Department Recruiting
Kiev, Ukraine, 01030
Ternopil University Hospital, Regional Centre of Gastroenterology with Hepatology Recruiting
Ternopil, Ukraine, 46001
Municipal Institution "Uzhgorod District Hospital", Therapeutics Department Recruiting
Uzhgorod, Ukraine, 88000
Municipal Healthcare Institution-Kharkiv City Clinical Hospital #2 Recruiting
Uzhgorod, Ukraine, 88009
Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No. 2 Recruiting
Vinnitsa, Ukraine, 21018
Vinnytsia Regional Clinical Hospital named after M.I. Pirogov, Gastroenterology Department Recruiting
Vinnitsya, Ukraine, 21018
Medical Center LLC "Health Clinic", Medical Clinical Investigational Center Recruiting
Vinnitsya, Ukraine, 21029
Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No.1 Recruiting
Vinnytsya, Ukraine, 21018
Municupal Institution "Zaporizhzhia City Multidisciplinary Clinic #9" Gastrointestinal Surgery Department, Recruiting
Zaporizhzhya, Ukraine, 69096
Municipal Institution "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council, Regional Center of Diagnostics, Recruiting
Zaporizhzhya, Ukraine, 69600
United Kingdom
Blackpool Teaching hospitals NHS Foundation Trust Recruiting
Blackpool, United Kingdom, FY3 8NR
Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, United Kingdom, CB2 0QQ
Royal Devon and Exeter NHS Foundation Trust Recruiting
Exeter, United Kingdom, EX2 5DW
Sponsors and Collaborators
Gilead Sciences
Galapagos NV
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03201445     History of Changes
Other Study ID Numbers: GS-US-418-4279
2017-000402-38 ( EudraCT Number )
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis