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

Lakefront Biotherapeutics NV116 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

116

Conditions

Ankylosing Spondylitis

Interventions

filgotinibDRUG

one filgotinib oral tablet q.d.

Placebo Oral TabletDRUG

one placebo oral tablet q.d.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (30)

Outcomes

Primary Outcomes

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

Time frame: week 12

Secondary Outcomes

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

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

To evaluate the effect of filgotinib on joint tenderness and swelling in AS patient

Time frame: week 12

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

Time frame: week 12

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

Time frame: week 12

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

Time frame: week 12

Assessment Spondyloarthritis Research Consortium of Canada MRI in filgotinib treated subjects as compared to placebo

Data from ClinicalTrials.gov

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