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 : January 29, 2019
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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 |

Arm | Intervention/treatment |
---|---|
Experimental: Double-Blind Filgotinib
Filgotinib for up to 26 weeks
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Drug: Filgotinib
200 mg tablet administered orally once daily |
Placebo Comparator: Double-Blind Placebo
Placebo for up to 26 weeks
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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
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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.
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Drug: Filgotinib
200 mg tablet administered orally once daily Drug: Placebo Tablet administered orally once daily |
- Proportion of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13 [ Time Frame: Week 13 ]
- Proportion of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26 [ Time Frame: Week 26 ]
- Change From Baseline in Percent Motile Sperm at Week 13 [ Time Frame: Week 13 ]
- Change From Baseline in Percent Motile Sperm at Week 26 [ Time Frame: Week 26 ]
- Change From Baseline in Total Sperm Count at Week 13 [ Time Frame: Week 13 ]
- Change From Baseline in Total Sperm Count at Week 26 [ Time Frame: Week 26 ]
- Change From Baseline in Sperm Concentration at Week 13 [ Time Frame: Week 13 ]
- Change From Baseline in Sperm Concentration at Week 26 [ Time Frame: Week 26 ]
- Change from Baseline in Ejaculate Volume at Week 13 [ Time Frame: Week 13 ]
- Change from Baseline in Ejaculate Volume at Week 26 [ Time Frame: Week 26 ]
- Change from Baseline in Percent Normal Sperm Morphology at Week 13 [ Time Frame: Week 13 ]
- 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 |
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

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

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: | January 29, 2019 |
Last Verified: | January 2019 |
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 |