Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease (MANTA)
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| ClinicalTrials.gov Identifier: NCT03201445 |
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Recruitment Status :
Active, not recruiting
First Posted : June 28, 2017
Last Update Posted : March 31, 2022
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Sponsor:
Gilead Sciences
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences
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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 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 |
|---|---|
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Experimental: Part A (Filgotinib or Placebo)
Participants will receive double-blind filgotinib or placebo for 13 weeks
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Drug: Filgotinib
200 mg tablet administered orally once daily Drug: Placebo Tablet administered orally once daily |
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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.
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Drug: Filgotinib
200 mg tablet administered orally once daily Drug: Placebo Tablet administered orally once daily |
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Experimental: Open-Label Filgotinib Phase
Participants will receive open-label filgotinib for up to 13 weeks.
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Drug: Filgotinib
200 mg tablet administered orally once daily |
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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.
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Drug: Standard of Care
Standard of care therapy options may include but are not limited to methotrexate |
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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.
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Drug: Filgotinib
200 mg tablet administered orally once daily Drug: Placebo Tablet administered orally once daily |
Primary Outcome Measures :
- Proportion of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13 [ Time Frame: Week 13 ]
Secondary Outcome Measures :
- 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 ]
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
Locations
Show 56 study locations
Sponsors and Collaborators
Gilead Sciences
Galapagos NV
Investigators
| Study Director: | Gilead Study Director | Gilead Sciences |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | March 31, 2022 |
| Last Verified: | March 2022 |
| 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 |