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Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Ulcerative Colitis (MANTA)

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ClinicalTrials.gov Identifier: NCT03201445
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : October 30, 2018
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 ulcerative colitis.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Filgotinib Drug: Placebo Drug: Standard of Care Phase 2

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 Ulcerative Colitis
Actual Study Start Date : July 11, 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Double-Blind Filgotinib
Filgotinib for up to 26 weeks
Drug: Filgotinib
200 mg tablet administered orally once daily

Placebo Comparator: Double-Blind Placebo
Placebo for up to 26 weeks
Drug: Placebo
Tablet administered orally once daily

Experimental: Monitoring Phase
Participants with ≥ 50% decline in sperm concentration will receive standard of care therapy in the monitoring phase
Drug: Standard of Care
Standard of care therapy

Experimental: Long Term Extension Phase
After Week 26, participants who did not experience a decrease of ≥ 50% in sperm concentration from baseline will have the option to enter into the long-term extension (LTE) phase of the study. Responders will continue on the same blinded study drug and non-responders will continue to receive open-label filgotinib for an additional 195 weeks.
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 ]


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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male participants who are between the ages of 25 and 55 (inclusive) on the day of signing informed consent
  • Documented diagnosis of ulcerative colitis (UC) of at least 4 months AND with a minimum disease extent of 15 cm from the anal verge. Documentation should include endoscopic and histopathologic evidence of UC
  • Have moderately to severely active UC

Key Exclusion Criteria:

  • Previously documented problems with male reproductive health
  • Prior diagnosis of male infertility
  • Presence of Crohn's disease (CD), indeterminate colitis, ischemic colitis, fulminant colitis, isolated ulcerative proctitis, or toxic mega-colon
  • Active tuberculosis (TB) or history of latent TB that has not been treated
  • 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
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

  Show 74 Study Locations
Sponsors and Collaborators
Gilead Sciences
Galapagos NV
Investigators
Study Director: Gilead Study Director Gilead Sciences

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: October 30, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases