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

Galapagos

Status and phase

Completed

Phase 2

Conditions

Ankylosing Spondylitis

Treatments

Drug: filgotinib

Drug: Placebo Oral Tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT03117270

GLPG0634-CL-223

Details and patient eligibility

About

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).

Enrollment

116 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and 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.