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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03926195




Registration number
NCT03926195
Ethics application status
Date submitted
19/04/2019
Date registered
24/04/2019
Date last updated
1/08/2023

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2018-003933-14
Secondary ID [2] 0 0
GLPG0634-CL-227
Universal Trial Number (UTN)
Trial acronym
MANTA-RAy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Psoriatic Arthritis 0 0
Ankylosing Spondylitis 0 0
Non-Radiographical Axial Spondyloarthritis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Filgotinib
Treatment: Drugs - Placebo
Treatment: Drugs - Standard of Care

Experimental: Filgotinib - 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.

Placebo Comparator: Placebo - 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.


Treatment: Drugs: Filgotinib
200-mg tablet administered orally once daily

Treatment: Drugs: Placebo
Placebo to match filgotinib tablet administered orally once daily

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With a = 50% Decrease From Baseline in Sperm Concentration at Week 13
Timepoint [1] 0 0
Baseline to Week 13
Secondary outcome [1] 0 0
Percentage of Participants With a = 50% Decrease From Baseline in Sperm Concentration at Week 26
Timepoint [1] 0 0
Baseline to Week 26
Secondary outcome [2] 0 0
Change From Baseline in Sperm Total Motility at Week 13
Timepoint [2] 0 0
Baseline, Week 13
Secondary outcome [3] 0 0
Change From Baseline in Sperm Total Motility at Week 26
Timepoint [3] 0 0
Baseline, Week 26
Secondary outcome [4] 0 0
Change From Baseline in Total Sperm Count at Week 13
Timepoint [4] 0 0
Baseline, Week 13
Secondary outcome [5] 0 0
Change From Baseline in Total Sperm Count at Week 26
Timepoint [5] 0 0
Baseline, Week 26
Secondary outcome [6] 0 0
Change From Baseline in Sperm Concentration at Week 13
Timepoint [6] 0 0
Baseline, Week 13
Secondary outcome [7] 0 0
Change From Baseline in Sperm Concentration at Week 26
Timepoint [7] 0 0
Baseline, Week 26
Secondary outcome [8] 0 0
Change From Baseline in Ejaculate Volume at Week 13
Timepoint [8] 0 0
Baseline, Week 13
Secondary outcome [9] 0 0
Change From Baseline in Ejaculate Volume at Week 26
Timepoint [9] 0 0
Baseline, Week 26
Secondary outcome [10] 0 0
Change From Baseline in Percent Normal Sperm Morphology at Week 13
Timepoint [10] 0 0
Baseline, Week 13
Secondary outcome [11] 0 0
Change From Baseline in Percent Normal Sperm Morphology at Week 26
Timepoint [11] 0 0
Baseline, Week 26

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
21 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/05/2023
Sample size
Target
Accrual to date
Final
109
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Pleven
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Plovdiv
Country [3] 0 0
Bulgaria
State/province [3] 0 0
Ruse
Country [4] 0 0
Bulgaria
State/province [4] 0 0
Sevlievo
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Sofia
Country [6] 0 0
Czechia
State/province [6] 0 0
Brno
Country [7] 0 0
Czechia
State/province [7] 0 0
Ostrava
Country [8] 0 0
Czechia
State/province [8] 0 0
Pardubice
Country [9] 0 0
Czechia
State/province [9] 0 0
Praha
Country [10] 0 0
Czechia
State/province [10] 0 0
Uherské Hradište
Country [11] 0 0
Estonia
State/province [11] 0 0
Tallinn
Country [12] 0 0
Estonia
State/province [12] 0 0
Tartu
Country [13] 0 0
Georgia
State/province [13] 0 0
Tbilisi
Country [14] 0 0
Latvia
State/province [14] 0 0
Adaži
Country [15] 0 0
Poland
State/province [15] 0 0
Bydgoszcz
Country [16] 0 0
Poland
State/province [16] 0 0
Katowice
Country [17] 0 0
Poland
State/province [17] 0 0
Knurów
Country [18] 0 0
Poland
State/province [18] 0 0
Lublin
Country [19] 0 0
Poland
State/province [19] 0 0
Poznan
Country [20] 0 0
Poland
State/province [20] 0 0
Sochaczew
Country [21] 0 0
Poland
State/province [21] 0 0
Warsaw
Country [22] 0 0
Poland
State/province [22] 0 0
Warszawa
Country [23] 0 0
Poland
State/province [23] 0 0
Lódz
Country [24] 0 0
Spain
State/province [24] 0 0
Santiago
Country [25] 0 0
Ukraine
State/province [25] 0 0
Dnipro
Country [26] 0 0
Ukraine
State/province [26] 0 0
Ivano-Frankivs'k
Country [27] 0 0
Ukraine
State/province [27] 0 0
Kharkiv
Country [28] 0 0
Ukraine
State/province [28] 0 0
Kherson
Country [29] 0 0
Ukraine
State/province [29] 0 0
Kyiv
Country [30] 0 0
Ukraine
State/province [30] 0 0
Luts'k
Country [31] 0 0
Ukraine
State/province [31] 0 0
Lviv
Country [32] 0 0
Ukraine
State/province [32] 0 0
Odesa
Country [33] 0 0
Ukraine
State/province [33] 0 0
Poltava
Country [34] 0 0
Ukraine
State/province [34] 0 0
Ternopil
Country [35] 0 0
Ukraine
State/province [35] 0 0
Vinnytsia
Country [36] 0 0
Ukraine
State/province [36] 0 0
Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Galapagos NV
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Gilead Sciences
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03926195
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Galapagos Study Director
Address 0 0
Galapagos NV
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries