Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease (MANTA)

• ClinicalTrials.gov Identifier: NCT03201445
• Recruitment Status: Recruiting
• First Posted: June 28, 2017
• Last Update Posted: October 1, 2019
• Sponsor: Gilead Sciences
• Collaborator: Galapagos NV
• Information provided by (Responsible Party): Gilead Sciences

Study Description

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

• 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

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

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

• 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

Contacts

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

  Show 144 Study Locations

Sponsors and Collaborators

Gilead Sciences

Galapagos NV

Investigators

• Study Director: Gilead Study Director; Gilead Sciences

More Information

• 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
• Last Update Posted: October 1, 2019
• Last Verified: September 2019

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

Additional relevant MeSH terms:

Intestinal Diseases; Inflammatory Bowel Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis