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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03201445
Recruitment Status : Active, not recruiting
First Posted : June 28, 2017
Last Update Posted : October 17, 2022
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Galapagos NV

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)
Actual Enrollment : 139 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
Actual Primary Completion Date : July 31, 2020
Estimated Study Completion Date : August 2024

Arm Intervention/treatment
Experimental: Part A (Filgotinib or Placebo)
Participants will receive double-blind filgotinib or placebo for 13 weeks
Drug: Filgotinib
200 mg tablet administered orally once daily

Drug: Placebo
Tablet administered orally once daily

Experimental: Part B (Filgotinib or Placebo)
Based on inflammatory bowel disease response status and sperm parameters, participants will continue on the blinded treatment for up to an additional 13 weeks 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 options may include but are not limited to methotrexate

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Locations
Show Show 56 study locations
Sponsors and Collaborators
Galapagos NV
Gilead Sciences
Investigators
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Study Director: Galapagos Study Director Galapagos NV
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Galapagos NV
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: October 17, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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