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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03117270
• Date of registration: 30/03/2017
• Prospective Registration: No
• Primary sponsor: Galapagos NV
• Public title: A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis TORTUGA
• Scientific 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
• Date of first enrolment: March 7, 2017
• Target sample size: 116
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03117270
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Pille Harrison, MD, DPhil, MRCP (UK)
• Affiliation: Galapagos NV

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: filgotinib

Drug: Placebo Oral Tablet

Primary Outcome(s)

Ankylosing Spondylitis disease activity score (ASDAS) in filgotinib treated subjects as compared to placebo [Time Frame: week 12]

Secondary Outcome(s)

Difference between the number of filgotinib treated subjects and placebo with abnormal radiographic assessment [Time Frame: At baseline and end of study visit (week 12)]

Assessment of the Maastricht Ankylosing Spondylitis Enthesitis Score in filgotinib treated subjects as compared to placebo [Time Frame: week 12]

Difference in the number of filgotinib subjects and placebo subjects with abnormal Clinical laboratory evaluations [Time Frame: from baseline until the final follow up visit (week 16)]

Assessment of Ankylosing Spondylitis Quality of Life questionnaire (ASQoL) in filgotinib treated subjects as compared to placebo [Time Frame: week 12]

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 [Time Frame: week 12]

Difference between the number of filgotinib treated subjects and placebo with abnormal ECG [Time Frame: At baseline, end of study visit (week 12) and final follow up visit (week 16)]

Assessment of the Bath Ankylosing Spondylitis Functional Index in filgotinib treated subjects as compared to placebo [Time Frame: week 12]

Assessment of the Bath Ankylosing Spondylitis Metrology Index in filgotinib treated subjects as compared to placebo [Time Frame: week 12]

Assessment Spondyloarthritis Research Consortium of Canada MRI in filgotinib treated subjects as compared to placebo [Time Frame: week 12]

Difference between the number of filgotinib treated subjects and placebo subjects with abnormal physical examination [Time Frame: from baseline until the final follow up visit (week 16)]

Assessment of FACIT fatigue scale in filgotinib treated subjects as compared to placebo [Time Frame: week 12]

Assessment of SF-36 health survey in filgotinib treated subjects as compared to placebo [Time Frame: week 12]

Assessment of SpondyloArthritis international Society (ASAS) in filgotinib treated subjects as compared to placebo [Time Frame: week 12]

Assessement of the Bath Ankylosing Spondylitis Disease Activity Index in filgotinib treated subjects as compared to placebo [Time Frame: week 12]

Difference between filgotinib treated subjects and placebo subjects in the number of Adverse events [Time Frame: from baseline until the final follow up visit (week 16)]

Difference in the number of filgotinib treated subjects and placebo subjects with abnormal vital signs [Time Frame: from baseline until the final follow up visit (week 16)]

Secondary ID(s)

GLPG0634-CL-223

Source(s) of Monetary Support

Please refer to primary and secondary sponsors