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Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis (MANTA-RAy)

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ClinicalTrials.gov Identifier: NCT03926195
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : June 29, 2020
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Galapagos NV

Study Description
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Brief Summary:

The primary objective of this study is to evaluate the effect of filgotinib on semen parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.

Results of this study may be pooled with the results of a separate study being conducted in participants with inflammatory bowel disease (Protocol GS-US-418-4279; NCT03201445) 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
Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis Non-Radiographical Axial Spondyloarthritis Drug: Filgotinib Drug: Placebo Drug: Standard of Care Phase 2

Study Design
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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 Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : October 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Double-Blind Phase: Filgotinib
Filgotinib up to Week 13
 Drug: Filgotinib
200-mg tablet administered orally once daily
Placebo Comparator: Double-Blind Phase: Placebo
Placebo up to Week 13
 Drug: Placebo
Placebo to match filgotinib tablet administered orally once daily
Experimental: Extension Phase: Open-Label Filgotinib
Participants who received double-blind filgotinib and did not meet prespecified decreases in sperm parameters (that is, ≥ 50% decrease from baseline in sperm concentration, and/or motility, and/or morphology) and were arthritis responders at Week 13 will enter the Extension Phase and receive open-label filgotinib up to Week 156. Participants who meet the criteria of prespecified decreases in sperm parameters anytime during the Extension Phase will enter the Monitoring Phase.
 Drug: Filgotinib
200-mg tablet administered orally once daily
Extension Phase: Standard of Care
Participants who received double-blind placebo and participants who received double-blind filgotinib and were arthritis non-responders who did not meet prespecified decreases in sperm parameters (that is, ≥ 50% decrease from baseline in sperm concentration, and/or motility, and/or morphology) at Week 13 will enter the Extension Phase and receive standard of care up to Week 156. Participants who meet the criteria of prespecified decreases in sperm parameters anytime during the Extension Phase will enter the Monitoring Phase.
 Drug: Standard of Care
Locally approved treatment, accepted by medical experts as a proper treatment for rheumatic conditions, prescribed according to best clinical practice, with no known testicular toxicity.
Monitoring Phase: Standard of Care
Participants with a prespecified decrease in sperm parameters (that is, ≥ 50% decrease from baseline in sperm concentration, and/or motility, and/or morphology) anytime at/after Week 13 will receive standard-of-care therapy as per investigator discretion in the Monitoring Phase for up to 52 weeks or until reversibility in semen parameters is met, whichever occurs first.
 Drug: Standard of Care
Locally approved treatment, accepted by medical experts as a proper treatment for rheumatic conditions, prescribed according to best clinical practice, with no known testicular toxicity.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with a ≥ 50% Decrease from Baseline in Sperm Concentration at Week 13 [ Time Frame: Week 13 ]

Secondary Outcome Measures :
  1. Percentage 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
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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 years (inclusive) on the day of signing informed consent
  • Diagnosis of active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or, non-radiographic axial spondyloarthritis for at least 12 weeks prior to screening, meeting the corresponding specific disease classification criteria as specified in the protocol

Key Exclusion Criteria:

  • Previously documented problems with male reproductive health
  • Prior diagnosis of male infertility
  • Use of any prohibited concomitant medication as outlined by protocol

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
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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): NCT03926195


Contacts
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Contact: Galapagos Medical Information +32 15 342900 medicalinfo@glpg.com

Locations
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Sponsors and Collaborators
Galapagos NV
Gilead Sciences
Investigators
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Study Director: Robin Besuyen, MD Galapagos NV
More Information
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Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03926195    
Other Study ID Numbers: GLPG0634-CL-227
2018-003933-14 ( EudraCT Number )
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
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
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Spondylitis
Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Spondylitis, Ankylosing
Spondylarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ankylosis