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

NCT03926195 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: GLPG0634-CL-2272018-003933-14
• Study Type: interventional
• Target: 109
• Locations: 7 countries
• Sites: 70

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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Non-Radiographical Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13

  Baseline for sperm/semen parameters was the mean of 2 evaluable semen samples at screening. The normal range for sperm concentration is ≥15 million sperms/mL. Percentage change = (\[mean at Week 13 - baseline\] / baseline) × 100; value at Week 13 was the mean of 2 evaluable samples collected at Week 13.

  Baseline to Week 13

Secondary Outcomes (11)

• Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26

  Baseline to Week 26

• Change From Baseline in Sperm Total Motility at Week 13

  Baseline, Week 13

• Change From Baseline in Sperm Total Motility at Week 26

  Baseline, Week 26

• Change From Baseline in Total Sperm Count at Week 13

  Baseline, Week 13

• Change From Baseline in Total Sperm Count at Week 26

  Baseline, Week 26

Study Arms (2)

Filgotinib

EXPERIMENTAL

Participants received filgotinib 200 milligrams (mg) tablet, orally, once daily up to Week 13 in the double-blind (DB) phase. At Week 13, participants who were arthritis responders, were unblinded and received open-label (OL) treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the extension (EXT) phase and participants who were arthritis nonresponders discontinued blinded study drug and started standard of care (SOC) treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.

Drug: Filgotinib; Drug: Standard of Care

Placebo

PLACEBO COMPARATOR

Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.

Drug: Placebo; Drug: Standard of Care

Interventions

Filgotinib DRUG

200-mg tablet administered orally once daily

Also known as: GS-6034, Jyseleca®

Filgotinib

Placebo DRUG

Placebo to match filgotinib tablet administered orally once daily

Placebo

Standard of Care DRUG

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.

Filgotinib; Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Galapagos NV: lead
• Gilead Sciences: collaborator

Study Sites (71)

Medical center Medconsult Pleven OOD

Pleven, 5800, Bulgaria

Location

UMHAT Pulmed OOD

Plovdiv, 4000, Bulgaria

Location

UMHAT Sv. Georgi, EAD

Plovdiv, 4000, Bulgaria

Location

MHAT "Eurohospital" - Plovdiv, OOD

Plovdiv, 4002, Bulgaria

Location

Medical Center Teodora, EOOD

Rousse, 7000, Bulgaria

Location

Medizinski Zentar-1-Sevlievo EOOD

Sevlievo, 5400, Bulgaria

Location

Medical Center Excelsior, OOD

Sofia, 1407, Bulgaria

Location

DCC Alexandrovska, EOOD

Sofia, 1431, Bulgaria

Location

UMHAT Sv. Ivan Rilski, EAD

Sofia, 1431, Bulgaria

Location

DCC 17 - Sofia EOOD

Sofia, 1504, Bulgaria

Location

Meditsinski Centar - Izgrev EOOD

Sofia, 1606, Bulgaria

Location

MC Synexus - Sofia, EOOD

Sofia, 1784, Bulgaria

Location

CCR Brno S.r.o.

Brno, 60200, Czechia

Location

CCBR Ostrava s.r.o

Ostrava, 702 00, Czechia

Location

Vesalion s.r.o.

Ostrava, 702 00, Czechia

Location

MUDr. Rosypalova s.r.o.

Ostrava, 708 00, Czechia

Location

Bioclinica Pardubice

Pardubice, 530 02, Czechia

Location

CLINTRIAL s.r.o.

Prague, 10000, Czechia

Location

Revmatologicky Ustav

Prague, 128 52, Czechia

Location

Thomayerova nemocnice

Prague, 140 59, Czechia

Location

MUDr Zuzana Stejfova Revmatologicka ambulance

Prague, 14000, Czechia

Location

Affidea Praha s.r.o.

Prague, 14800, Czechia

Location

MEDICAL PLUS s.r.o.

Uherské Hradiště, 68601, Czechia

Location

OÜ Innomedica

Tallinn, 10117, Estonia

Location

Center for Clinical and Basic Research

Tallinn, 10128, Estonia

Location

North Estonia Medical Centre Foundation

Tallinn, 13419, Estonia

Location

Clinical Research Centre

Tartu, 50106, Estonia

Location

Meditrials OU

Tartu, 50406, Estonia

Location

Chapidze Emergency Cardiology Center

Tbilisi, 0159, Georgia

Location

Institute of Clinical Cardiology Ltd

Tbilisi, 0159, Georgia

Location

National Institute of Endocrinology

Tbilisi, 0159, Georgia

Location

Tbilisi Heart and Vascular Clinic Ltd

Tbilisi, 0159, Georgia

Location

Aversi ClinicLtd.

Tbilisi, 0160, Georgia

Location

Clinic on Mtskheta Street

Tbilisi, 0179, Georgia

Location

Consilium Medulla-multiprofile clinic Ltd

Tbilisi, 0186, Georgia

Location

Medicore Ltd.

Tbilisi, 0186, Georgia

Location

M&M center

Ādaži, LV2164, Latvia

Location

Nasz Lekarz Osrodek Badan Klinicznych

Bydgoszcz, 85-065, Poland

Location

Szpital Uniwersytecki nr 2 im. dr J. Biziela

Bydgoszcz, 85-168, Poland

Location

Silmedic sp. z o.o

Katowice, 40-282, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla

Knurów, 44-190, Poland

Location

Centrum Medyczne AMED

Lodz, 91-363, Poland

Location

Zespol Poradni Specjalistycznych REUMED

Lublin, 20-607, Poland

Location

SOLUMED Centrum Medyczne

Poznan, 60-529, Poland

Location

Centrum Badan Klinicznych S.C.

Poznan, 60-773, Poland

Location

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

Poznan, 61-113, Poland

Location

RCMed

Sochaczew, 96-500, Poland

Location

Medycyna Kliniczna

Warsaw, 00-874, Poland

Location

Centrum Medyczne AMED

Warsaw, 03-291, Poland

Location

Clinica GAIAS

Santiago, 15702, Spain

Location

CI Dnipropetrovsk CMCH #4 RC

Dnipro, 49102, Ukraine

Location

Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU

Ivano-Frankivsk, 76008, Ukraine

Location

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

Kharkiv, 61039, Ukraine

Location

CHI Kharkiv City Clinical Hospital #13

Kharkiv, 61124, Ukraine

Location

CI A.and O. Tropiny City Clinical Hospital

Kherson, 73000, Ukraine

Location

Medical Center of Limited Liability Company Medical Clinic Blagomed

Kyiv, 01023, Ukraine

Location

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

Kyiv, 02091, Ukraine

Location

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

Kyiv, 03680, Ukraine

Location

Limited Liability Company Medical Center Concilium Medical

Kyiv, 04050, Ukraine

Location

LLC Treatment-Diagnostic Center ADONIS plus

Kyiv, 04050, Ukraine

Location

Volyn Regional Clinical Hospital

Lutsk, 43005, Ukraine

Location

Lviv Regional Clinical Hospital Dept of Rheumatology NMU

Lviv, 79000, Ukraine

Location

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

Lviv, 79049, Ukraine

Location

Center of Reconstructive & Restorative Medicine of Odessa National Medical University

Odesa, 65000, Ukraine

Location

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

Poltava, 36011, Ukraine

Location

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

Ternopil, 46002, Ukraine

Location

Private Small Enterprise Medical Center Pulse

Vinnytsia, 21001, Ukraine

Location

Vinnytsia M.I.Pyrogov RCH Dept of cardiology NMU

Vinnytsia, 21018, Ukraine

Location

MCIC Health Clinic BO LTD TDC Slaomed

Vinnytsia, 21029, Ukraine

Location

CI CCH #6 Dept of Therapy ZSMU

Zaporizhzhya, 69035, Ukraine

Location

CI Zaporizhzhia Regional Clinical Hospital of ZRC

Zaporizhzhya, 69600, Ukraine

Location

Related Publications (2)

• Reinisch W, Hellstrom W, Dolhain RJEM, Sikka S, Westhovens R, Mehta R, Ritter T, Seidler U, Golovchenko O, Simanenkov V, Garmish O, Jeka S, Moravcova R, Rajendran V, Le Brun FO, Arterburn S, Watkins TR, Besuyen R, Vanderschueren D. Effects of filgotinib on semen parameters and sex hormones in male patients with inflammatory diseases: results from the phase 2, randomised, double-blind, placebo-controlled MANTA and MANTA-RAy studies. Ann Rheum Dis. 2023 Aug;82(8):1049-1058. doi: 10.1136/ard-2023-224017. Epub 2023 May 3.

  PMID: 37137672 DERIVED

• Hellstrom WJG, Dolhain RJEM, Ritter TE, Watkins TR, Arterburn SJ, Dekkers G, Gillen A, Tonussi C, Gilles L, Oortwijn A, Van Beneden K, de Vries DE, Sikka SC, Vanderschueren D, Reinisch W. MANTA and MANTA-RAy: Rationale and Design of Trials Evaluating Effects of Filgotinib on Semen Parameters in Patients with Inflammatory Diseases. Adv Ther. 2022 Jul;39(7):3403-3422. doi: 10.1007/s12325-022-02168-4. Epub 2022 May 25.

  PMID: 35614292 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing

Interventions

GLPG0634; Standard of Care

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Axial Spondyloarthritis; Ankylosis

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Galapagos Medical Information
• Organization: Galapagos NV

medicalinfo@glpg.com

+32 15 342 900

Study Officials

• Galapagos Study Director

  Galapagos NV

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 24, 2019
• Study Start: May 28, 2019
• Primary Completion: August 14, 2020
• Study Completion: May 10, 2023
• Last Updated: April 30, 2024
• Results First Posted: August 1, 2023

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (11); ES (5); PL (12); GE (8); LA (1); BU (12); UA (21)