A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

— TORTUGA  

Official title:

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 12 Weeks to Subjects With Active Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03117270
• Other study ID #: GLPG0634-CL-223
• Status: Completed
• Phase: Phase 2
• Start date: March 7, 2017
• Est. completion date: July 2, 2018

Study information

• Verified date: August 2018
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: July 2, 2018
• Est. primary completion date: July 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• 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 Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• filgotinib
one filgotinib oral tablet q.d.
• Placebo Oral Tablet
one placebo oral tablet q.d.

Locations

Country	Name	City	State
Belgium	ULB Hopital Erasme, Service de Rheumatology	Brussels
Bulgaria	Eurohospital	Plovdiv
Bulgaria	UMHAT Kaspela EOOD	Plovdiv
Bulgaria	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	UMHAT "SofiaMed", OOD, Block 1	Sofia
Bulgaria	Medical Center "Nov Rehabilitatsionen Tsentar", EOOD	Stara Zagora
Czechia	Revmatologicka ambulance	Ostrava
Czechia	CCBR Czech, a.s	Pardubice
Czechia	MEDICAL PLUS s.r.o.	Uherské Hradište
Estonia	OÜ Innomedica	Tallinn
Poland	Centrum Medyczne SILESIANA Sp z oo	Bytom
Poland	Twoja Przychodnia-Centrum Medyczne Nowa Sol	Nowa Sól
Poland	Ai Centrum Medyczne sp. z o.o. sp.k.	Poznan
Poland	Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna	Torun
Poland	Centrum Medyczne AMED, Warszawa Targowek	Warsaw
Spain	Corporacio Sanitaria Parc Tauli, Servicio de Reumatologia	Santiago de Compostela
Spain	Hospital Infanta Luisa, Servicio de Reumatologia	Sevilla
Spain	Hospital Universitario Virgen Macarena, Dept. of Rheumatology	Sevilla
Ukraine	CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics	Kharkiv
Ukraine	CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy	Kiev
Ukraine	SI NS? 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	CI of TRC	Ternopil'
Ukraine	A.Novak Transcarpathian Regional Clinical Hospital, Dept of Rheumatology	Uzhgorod
Ukraine	M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1	Vinnytsia
Ukraine	SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy	Vinnytsia
Ukraine	MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology	Vinnytsya

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Czechia,  Estonia,  Poland,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ankylosing Spondylitis disease activity score (ASDAS) in filgotinib treated subjects as compared to placebo	To evaluate the effect of filgotinib on the AS disease activity score	week 12
Secondary	Assessment of SpondyloArthritis international Society (ASAS) in filgotinib treated subjects as compared to placebo	To evaluation the effect of filgotinib on the ASAS score in AS patients	week 12
Secondary	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	To evaluate the effect of filgotinib on joint tenderness and swelling in AS patient	week 12
Secondary	Assessement of the Bath Ankylosing Spondylitis Disease Activity Index in filgotinib treated subjects as compared to placebo	To assess the effect of filgotinib on BAS disease activity index in AS patients	week 12
Secondary	Assessment of the Bath Ankylosing Spondylitis Functional Index in filgotinib treated subjects as compared to placebo	To assess the effect of filgotinib on BAS functional index in AS patients	week 12
Secondary	Assessment of the Bath Ankylosing Spondylitis Metrology Index in filgotinib treated subjects as compared to placebo	To assess the effect of filgotinib on BAS metrology index in AS patients	week 12
Secondary	Assessment Spondyloarthritis Research Consortium of Canada MRI in filgotinib treated subjects as compared to placebo	To assess the effect of filogtinib on Spondyloarthritis Research Consortium of Canada MRI in AS patients	week 12
Secondary	Assessment of the Maastricht Ankylosing Spondylitis Enthesitis Score in filgotinib treated subjects as compared to placebo	To assess the effect of filgotinibe on Maastricht Ankylosing Spondylitis Enthesitis Score in AS patients	week 12
Secondary	Assessment of FACIT fatigue scale in filgotinib treated subjects as compared to placebo	To assess the effect of filgotinib on FACIT fatigue scale in AS patients	week 12
Secondary	Assessment of SF-36 health survey in filgotinib treated subjects as compared to placebo	To assess the effect of filgotinib on SF-36 health survey in AS patients	week 12
Secondary	Assessment of Ankylosing Spondylitis Quality of Life questionnaire (ASQoL) in filgotinib treated subjects as compared to placebo	To assess the effect of filgotinib on ASQoL in AS patients	week 12
Secondary	Difference between filgotinib treated subjects and placebo subjects in the number of Adverse events	To assess safety and tolerability of filgotinib in AS patients	from baseline until the final follow up visit (week 16)
Secondary	Difference in the number of filgotinib subjects and placebo subjects with abnormal Clinical laboratory evaluations	To assess safety and tolerability of filgotinib in AS patients	from baseline until the final follow up visit (week 16)
Secondary	Difference in the number of filgotinib treated subjects and placebo subjects with abnormal vital signs	To assess safety and tolerability of filgotinib in AS patients	from baseline until the final follow up visit (week 16)
Secondary	Difference between the number of filgotinib treated subjects and placebo subjects with abnormal physical examination	To assess safety and tolerability of filgotinib in AS patients	from baseline until the final follow up visit (week 16)
Secondary	Difference between the number of filgotinib treated subjects and placebo with abnormal ECG	To assess safety and tolerability of filgotinib in AS patients	At baseline, end of study visit (week 12) and final follow up visit (week 16)
Secondary	Difference between the number of filgotinib treated subjects and placebo with abnormal radiographic assessment	To assess safety and tolerability of filgotinib in AS patients	At baseline and end of study visit (week 12)