A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis
- Conditions
- Ankylosing Spondylitis
- Interventions
- Drug: Placebo Oral Tablet
- Registration Number
- NCT03117270
- Lead Sponsor
- Galapagos NV
- Brief Summary
This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with active Ankylosing Spondylitis (AS). A total of approximately 100 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo q.d. Treatment duration will be 12 weeks. Each subject will stay in the study for a maximum of 20 weeks (from Screening visit to Follow-up visit).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- Male or female subjects who are ≥18 years of age on the day of signing informed consent.
- Diagnosis of moderate to severe ankylosing spondylitis with documented evidence of fulfilling the Modified New York (NY) criteria
- Have active ankylosing spondylitis with a BASDAI ≥4 (numeric rating scale [NRS] 0-10) and spinal pain ≥4 (0-10 NRS) (based on BASDAI question 2, see protocol) at screening and baseline.
- Have had a documented inadequate response to NSAIDs including cyclooxygenase-2 (COX-2) inhibitors.
- If using cDMARD therapy, stable dose for at lead 4 weeks prior to Baseline.
- If using non-drug therapies (including physical therapies), these should be kept stable during screening.
- Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use highly effective methods of contraception as described in the protocol.
Key
- Use of JAK inhibitors, investigational or approved, at any time, including filgotinib;
- Prior use of more than one TNF inhibitor, at any time.
- Use of oral steroids at a dose >10 mg/day of prednisone or prednisone equivalent or at a dose that hasn't been stable for at least 4 weeks prior to baseline;
- Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronate) within 4 weeks prior to screening;
- Use of more than 1 NSAID or COX-2 inhibitor.
- Contraindication to MRI.
- History of known or suspected complete ankylosis of the spine.
- Presence of very poor functional status or unable to perform self-care.
- Have undergone surgical treatment for ankylosing spondylitis within the last 12 weeks prior to screening.
- Administration of a live or attenuated vaccine within 12 weeks prior to baseline.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo tablets Placebo Oral Tablet - oral filgotinib tablets filgotinib -
- Primary Outcome Measures
Name Time Method Ankylosing Spondylitis disease activity score (ASDAS) in filgotinib treated subjects as compared to placebo week 12 To evaluate the effect of filgotinib on the AS disease activity score
- Secondary Outcome Measures
Name Time Method Assessment of the Bath Ankylosing Spondylitis Metrology Index in filgotinib treated subjects as compared to placebo week 12 To assess the effect of filgotinib on BAS metrology index in AS patients
Assessment Spondyloarthritis Research Consortium of Canada MRI in filgotinib treated subjects as compared to placebo week 12 To assess the effect of filogtinib on Spondyloarthritis Research Consortium of Canada MRI in AS patients
Assessment of the Maastricht Ankylosing Spondylitis Enthesitis Score in filgotinib treated subjects as compared to placebo week 12 To assess the effect of filgotinibe on Maastricht Ankylosing Spondylitis Enthesitis Score in AS patients
Assessment of FACIT fatigue scale in filgotinib treated subjects as compared to placebo week 12 To assess the effect of filgotinib on FACIT fatigue scale in AS patients
Assessment of SF-36 health survey in filgotinib treated subjects as compared to placebo week 12 To assess the effect of filgotinib on SF-36 health survey in AS patients
Assessment of Ankylosing Spondylitis Quality of Life questionnaire (ASQoL) in filgotinib treated subjects as compared to placebo week 12 To assess the effect of filgotinib on ASQoL in AS patients
Difference between filgotinib treated subjects and placebo subjects in the number of Adverse events from baseline until the final follow up visit (week 16) To assess safety and tolerability of filgotinib in AS patients
Difference in the number of filgotinib subjects and placebo subjects with abnormal Clinical laboratory evaluations from baseline until the final follow up visit (week 16) To assess safety and tolerability of filgotinib in AS patients
Difference in the number of filgotinib treated subjects and placebo subjects with abnormal vital signs from baseline until the final follow up visit (week 16) To assess safety and tolerability of filgotinib in AS patients
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal physical examination from baseline until the final follow up visit (week 16) To assess safety and tolerability of filgotinib in AS patients
Difference between the number of filgotinib treated subjects and placebo with abnormal ECG At baseline, end of study visit (week 12) and final follow up visit (week 16) To assess safety and tolerability of filgotinib in AS patients
Difference between the number of filgotinib treated subjects and placebo with abnormal radiographic assessment At baseline and end of study visit (week 12) To assess safety and tolerability of filgotinib in AS patients
Assessment of SpondyloArthritis international Society (ASAS) in filgotinib treated subjects as compared to placebo week 12 To evaluation the effect of filgotinib on the ASAS score in AS patients
Assessment by a trained joint assessor of 44 joints for tenderness (counting the number or tender joints - TJC) and swelling (counting the number of swollen joints - SJC) in filgotinib treated subjects as compared to placebo week 12 To evaluate the effect of filgotinib on joint tenderness and swelling in AS patient
Assessement of the Bath Ankylosing Spondylitis Disease Activity Index in filgotinib treated subjects as compared to placebo week 12 To assess the effect of filgotinib on BAS disease activity index in AS patients
Assessment of the Bath Ankylosing Spondylitis Functional Index in filgotinib treated subjects as compared to placebo week 12 To assess the effect of filgotinib on BAS functional index in AS patients
Trial Locations
- Locations (30)
Centrum Medyczne SILESIANA Sp z oo
🇵🇱Bytom, Poland
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh
🇺🇦Kiev, Ukraine
CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Ch of Family Medicine & Dermatology, Venereology
🇺🇦L'viv, Ukraine
M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy
🇺🇦Poltava, Ukraine
A.Novak Transcarpathian Regional Clinical Hospital, Dept of Rheumatology
🇺🇦Uzhgorod, Ukraine
SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy
🇺🇦Vinnytsia, Ukraine
ULB Hopital Erasme, Service de Rheumatology
🇧🇪Brussels, Belgium
Medical Center "Teodora", EOOD
🇧🇬Ruse, Bulgaria
Akademik Ivan Geshov, UMHAT "Sv. Ivan Rilski", EAD
🇧🇬Sofia, Bulgaria
Clinic of Rheumatology, UMHAT "Sv. Ivan Rilski", EAD
🇧🇬Sofia, Bulgaria
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
🇧🇬Stara Zagora, Bulgaria
Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna
🇵🇱Toruń, Poland
Eurohospital
🇧🇬Plovdiv, Bulgaria
OÜ Innomedica
🇪🇪Tallinn, Estonia
M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1
🇺🇦Vinnytsia, Ukraine
Revmatologicka ambulance
🇨🇿Ostrava, Czechia
Hospital Infanta Luisa, Servicio de Reumatologia
🇪🇸Sevilla, Spain
UMHAT Kaspela EOOD
🇧🇬Plovdiv, Bulgaria
UMHAT "SofiaMed", OOD, Block 1
🇧🇬Sofia, Bulgaria
CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy
🇺🇦Kiev, Ukraine
CCBR Czech, a.s
🇨🇿Pardubice, Czechia
Hospital Universitario Virgen Macarena, Dept. of Rheumatology
🇪🇸Sevilla, Spain
Twoja Przychodnia-Centrum Medyczne Nowa Sol
🇵🇱Nowa Sól, Poland
Ai Centrum Medyczne sp. z o.o. sp.k.
🇵🇱Poznań, Poland
Centrum Medyczne AMED, Warszawa Targowek
🇵🇱Warsaw, Poland
CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics
🇺🇦Kharkiv, Ukraine
MEDICAL PLUS s.r.o.
🇨🇿Uherské Hradiště, Czechia
Corporacio Sanitaria Parc Tauli, Servicio de Reumatologia
🇪🇸Santiago de Compostela, Spain
CI of TRC
🇺🇦Ternopil', Ukraine
MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology
🇺🇦Vinnytsya, Ukraine