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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 : May 29, 2020
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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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

Study Design
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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
Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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

Contacts and Locations
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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

Locations
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Sponsors and Collaborators
Gilead Sciences
Galapagos NV
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03201445    
Other Study ID Numbers: GS-US-418-4279
2017-000402-38 ( EudraCT Number )
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020

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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