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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 21 Years - 65 Years
Gender Male
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03926195
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Galapagos NV
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Robin Besuyen, MD
Principal Investigator Affiliation Galapagos NV
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Bosnia and Herzegovina, Bulgaria, Czechia, Estonia, Georgia, Latvia, Poland, Spain, Ukraine
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Non-Radiographical Axial Spondyloarthritis
Arms & Interventions

Arms

Experimental: Double-Blind Phase: Filgotinib

Filgotinib up to Week 13

Placebo Comparator: Double-Blind Phase: Placebo

Placebo up to Week 13

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.

Other: 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.

Other: 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.

Interventions

Drug: - Filgotinib

200-mg tablet administered orally once daily

Drug: - Placebo

Placebo to match filgotinib tablet administered orally once daily

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

UZ Leuven, Pellenberg, Belgium

Status

Terminated

Address

UZ Leuven

Pellenberg, , 3212

University Clinical Hospital Mostar, Mostar, Bosnia and Herzegovina

Status

Recruiting

Address

University Clinical Hospital Mostar

Mostar, , 88000

Medical center Medconsult Pleven OOD, Pleven, Bulgaria

Status

Recruiting

Address

Medical center Medconsult Pleven OOD

Pleven, , 5800

UMHAT Pulmed OOD, Plovdiv, Bulgaria

Status

Terminated

Address

UMHAT Pulmed OOD

Plovdiv, , 4000

UMHAT Sv. Georgi, EAD, Plovdiv, Bulgaria

Status

Recruiting

Address

UMHAT Sv. Georgi, EAD

Plovdiv, , 4000

MHAT "Eurohospital" - Plovdiv, OOD, Plovdiv, Bulgaria

Status

Terminated

Address

MHAT "Eurohospital" - Plovdiv, OOD

Plovdiv, , 4002

Medical Center Teodora, EOOD, Ruse, Bulgaria

Status

Recruiting

Address

Medical Center Teodora, EOOD

Ruse, , 7000

Medizinski Zentar-1-Sevlievo EOOD, Sevlievo, Bulgaria

Status

Recruiting

Address

Medizinski Zentar-1-Sevlievo EOOD

Sevlievo, , 5400

Medical Center Excelsior, OOD, Sofia, Bulgaria

Status

Terminated

Address

Medical Center Excelsior, OOD

Sofia, , 1407

DCC Alexandrovska, EOOD, Sofia, Bulgaria

Status

Recruiting

Address

DCC Alexandrovska, EOOD

Sofia, , 1431

UMHAT Sv. Ivan Rilski, EAD, Sofia, Bulgaria

Status

Terminated

Address

UMHAT Sv. Ivan Rilski, EAD

Sofia, , 1431

DCC 17 - Sofia EOOD, Sofia, Bulgaria

Status

Recruiting

Address

DCC 17 - Sofia EOOD

Sofia, , 1504

Meditsinski Centar - Izgrev EOOD, Sofia, Bulgaria

Status

Terminated

Address

Meditsinski Centar - Izgrev EOOD

Sofia, , 1606

MC Synexus - Sofia, EOOD, Sofia, Bulgaria

Status

Terminated

Address

MC Synexus - Sofia, EOOD

Sofia, , 1784

CCR Brno S.r.o., Brno, Czechia

Status

Recruiting

Address

CCR Brno S.r.o.

Brno, , 60200

CCBR Ostrava s.r.o, Ostrava, Czechia

Status

Recruiting

Address

CCBR Ostrava s.r.o

Ostrava, , 702 00

Vesalion s.r.o., Ostrava, Czechia

Status

Recruiting

Address

Vesalion s.r.o.

Ostrava, , 702 00

MUDr. Rosypalova s.r.o., Ostrava, Czechia

Status

Recruiting

Address

MUDr. Rosypalova s.r.o.

Ostrava, , 708 00

Bioclinica Pardubice, Pardubice, Czechia

Status

Recruiting

Address

Bioclinica Pardubice

Pardubice, , 530 02

CLINTRIAL s.r.o., Praha, Czechia

Status

Recruiting

Address

CLINTRIAL s.r.o.

Praha, , 10000

Revmatologicky Ustav, Praha, Czechia

Status

Recruiting

Address

Revmatologicky Ustav

Praha, , 128 52

Thomayerova nemocnice, Praha, Czechia

Status

Terminated

Address

Thomayerova nemocnice

Praha, , 140 59

Praha, Czechia

Status

Terminated

Address

MUDr Zuzana Stejfova Revmatologicka ambulance

Praha, , 14000

Affidea Praha s.r.o., Praha, Czechia

Status

Terminated

Address

Affidea Praha s.r.o.

Praha, , 14800

MEDICAL PLUS s.r.o., Uherské Hradiště, Czechia

Status

Recruiting

Address

MEDICAL PLUS s.r.o.

Uherské Hradiště, , 68601

OÜ Innomedica, Tallinn, Estonia

Status

Recruiting

Address

OÜ Innomedica

Tallinn, , 10117

Center for Clinical and Basic Research, Tallinn, Estonia

Status

Recruiting

Address

Center for Clinical and Basic Research

Tallinn, , 10128

North Estonia Medical Centre Foundation, Tallinn, Estonia

Status

Recruiting

Address

North Estonia Medical Centre Foundation

Tallinn, , 13419

Clinical Research Centre, Tartu, Estonia

Status

Recruiting

Address

Clinical Research Centre

Tartu, , 50106

Meditrials OU, Tartu, Estonia

Status

Recruiting

Address

Meditrials OU

Tartu, , 50406

Chapidze Emergency Cardiology Center, Tbilisi, Georgia

Status

Recruiting

Address

Chapidze Emergency Cardiology Center

Tbilisi, , 0159

Institute of Clinical Cardiology Ltd, Tbilisi, Georgia

Status

Recruiting

Address

Institute of Clinical Cardiology Ltd

Tbilisi, , 0159

National Institute of Endocrinology, Tbilisi, Georgia

Status

Recruiting

Address

National Institute of Endocrinology

Tbilisi, , 0159

Tbilisi Heart and Vascular Clinic Ltd, Tbilisi, Georgia

Status

Recruiting

Address

Tbilisi Heart and Vascular Clinic Ltd

Tbilisi, , 0159

Aversi ClinicLtd., Tbilisi, Georgia

Status

Recruiting

Address

Aversi ClinicLtd.

Tbilisi, , 0160

Clinic on Mtskheta Street, Tbilisi, Georgia

Status

Recruiting

Address

Clinic on Mtskheta Street

Tbilisi, , 0179

Tbilisi, Georgia

Status

Recruiting

Address

Consilium Medulla-multiprofile clinic Ltd

Tbilisi, , 0186

Medicore Ltd., Tbilisi, Georgia

Status

Terminated

Address

Medicore Ltd.

Tbilisi, , 0186

M&M center, Ādaži, Latvia

Status

Recruiting

Address

M&M center

Ādaži, , LV2164

Nasz Lekarz Osrodek Badan Klinicznych, Bydgoszcz, Poland

Status

Recruiting

Address

Nasz Lekarz Osrodek Badan Klinicznych

Bydgoszcz, , 85-065

Bydgoszcz, Poland

Status

Recruiting

Address

Szpital Uniwersytecki nr 2 im. dr J. Biziela

Bydgoszcz, , 85-168

Silmedic sp. z o.o, Katowice, Poland

Status

Recruiting

Address

Silmedic sp. z o.o

Katowice, , 40-282

Knurów, Poland

Status

Recruiting

Address

Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla

Knurów, , 44-190

Zespol Poradni Specjalistycznych REUMED, Lublin, Poland

Status

Recruiting

Address

Zespol Poradni Specjalistycznych REUMED

Lublin, , 20-607

SOLUMED Centrum Medyczne, Poznań, Poland

Status

Terminated

Address

SOLUMED Centrum Medyczne

Poznań, , 60-529

Centrum Badan Klinicznych S.C., Poznań, Poland

Status

Recruiting

Address

Centrum Badan Klinicznych S.C.

Poznań, , 60-773

Ai Centrum Medyczne Sp. Z O.O. Sp.K., Poznań, Poland

Status

Recruiting

Address

Ai Centrum Medyczne Sp. Z O.O. Sp.K.

Poznań, , 61-113

RCMed, Sochaczew, Poland

Status

Recruiting

Address

RCMed

Sochaczew, , 96-500

Medycyna Kliniczna, Warsaw, Poland

Status

Recruiting

Address

Medycyna Kliniczna

Warsaw, , 00-874

Centrum Medyczne AMED, Warszawa, Poland

Status

Terminated

Address

Centrum Medyczne AMED

Warszawa, , 03-291

Centrum Medyczne AMED, Łódź, Poland

Status

Terminated

Address

Centrum Medyczne AMED

Łódź, , 91-363

Clinica GAIAS, Santiago, Spain

Status

Recruiting

Address

Clinica GAIAS

Santiago, , 15702

CI Dnipropetrovsk CMCH #4 RC, Dnipro, Ukraine

Status

Recruiting

Address

CI Dnipropetrovsk CMCH #4 RC

Dnipro, , 49102

Ivano-Frankivs'k, Ukraine

Status

Terminated

Address

Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU

Ivano-Frankivs'k, , 76008

Kharkiv, Ukraine

Status

Terminated

Address

GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine

Kharkiv, , 61039

CHI Kharkiv City Clinical Hospital #13, Kharkiv, Ukraine

Status

Recruiting

Address

CHI Kharkiv City Clinical Hospital #13

Kharkiv, , 61124

Kherson, Ukraine

Status

Terminated

Address

CI A.and O. Tropiny City Clinical Hospital

Kherson, , 73000

Kyiv, Ukraine

Status

Terminated

Address

Medical Center of Limited Liability Company Medical Clinic Blagomed

Kyiv, , 01023

Kyiv, Ukraine

Status

Recruiting

Address

Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC

Kyiv, , 02091

Kyiv, Ukraine

Status

Recruiting

Address

SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU

Kyiv, , 03680

Kyiv, Ukraine

Status

Recruiting

Address

Limited Liability Company Medical Center Concilium Medical

Kyiv, , 04050

Kyiv, Ukraine

Status

Recruiting

Address

LLC Treatment-Diagnostic Center ADONIS plus

Kyiv, , 04050

Volyn Regional Clinical Hospital, Luts'k, Ukraine

Status

Recruiting

Address

Volyn Regional Clinical Hospital

Luts'k, , 43005

Lviv, Ukraine

Status

Terminated

Address

Lviv Regional Clinical Hospital Dept of Rheumatology NMU

Lviv, , 79000

Lviv, Ukraine

Status

Recruiting

Address

Mil&Med Cl C of Lviv of the St Border Service of Ukraine

Lviv, , 79049

Odesa, Ukraine

Status

Recruiting

Address

Center of Reconstructive & Restorative Medicine of Odessa National Medical University

Odesa, , 65000

Poltava, Ukraine

Status

Terminated

Address

M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA

Poltava, , 36011

Ternopil, Ukraine

Status

Terminated

Address

Ternopil University Hospital, Dept. of Rheumatology, SHEI I.Ya.Horbachevskyi Ternopil SMU

Ternopil, , 46002

Vinnytsia, Ukraine

Status

Terminated

Address

Private Small Enterprise Medical Center Pulse

Vinnytsia, , 21001

Vinnytsia, Ukraine

Status

Recruiting

Address

Vinnytsia M.I.Pyrogov RCH Dept of cardiology NMU

Vinnytsia, , 21018

MCIC Health Clinic BO LTD TDC Slaomed, Vinnytsia, Ukraine

Status

Terminated

Address

MCIC Health Clinic BO LTD TDC Slaomed

Vinnytsia, , 21029

CI CCH #6 Dept of Therapy ZSMU, Zaporizhzhya, Ukraine

Status

Terminated

Address

CI CCH #6 Dept of Therapy ZSMU

Zaporizhzhya, , 69035

Zaporizhzhya, Ukraine

Status

Recruiting

Address

CI Zaporizhzhia Regional Clinical Hospital of ZRC

Zaporizhzhya, , 69600

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