Status:
WITHDRAWN
Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drug Therapy
Lead Sponsor:
Gilead Sciences
Collaborating Sponsors:
Galapagos NV
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to evaluate the effect of filgotinib versus placebo on signs and symptoms of active ankylosing spondylitis (AS), evaluated by Assessment of SpondyloArthritis int...
Detailed Description
The study consists of 2 parts: Main Study (screening through Week 16) and Long-Term Extension (LTE) (up to 1.5 years after Week 16). Participants who permanently discontinue treatment in the Main Stud...
Eligibility Criteria
Inclusion
- Key
- Ambulatory male or female, ≥ 18 years of age (≥ 20 years of age in Japan) on the day of signing initial informed consent
- Have an established diagnosis of radiographic axial spondyloarthritis (SpA)/ ankylosing spondylitis (AS) by a rheumatologist (or other specialist with expertise diagnosing AS)
- Meet Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial SpA with radiographic sacroiliitis on imaging at screening as follows:
- History of back pain ≥ 3 months and age at onset of back pain \< 45 years, AND
- Radiographic sacroiliitis Grade ≥ 2 bilaterally or Grade 3-4 unilaterally, AND
- ≥ 1 SpA feature (refer to protocol; inflammatory back pain, arthritis, heel enthesitis, uveitis anterior, dactylitis, psoriasis, inflammatory bowel disease, good response to nonsteroidal anti-inflammatory drugs (NSAIDs), family history of SpA, historically positive human leukocyte antigen B27 (HLA-B27), elevated C-reactive protein (CRP))
- Have active AS at screening and Day 1 defined by:
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4, AND
- Spinal pain score ≥ 4 (based on BASDAI question 2)
- Have had an inadequate response to ≥ 2 NSAIDs at a therapeutic dose range for ≥ 2 weeks each (a total duration of NSAID trial ≥ 4 weeks) or intolerance to ≥ 2 NSAIDs for the treatment of AS
- If using allowed conventional synthetic disease-modifying antirheumatic drug (csDMARD), NSAID, or corticosteroid therapy, must have been on stable doses (as outlined in protocol) prior to Day 1
- Key
Exclusion
- Contraindication to magnetic resonance imaging (MRI)
- Prior exposure to a biologic disease-modifying antirheumatic drug (bioDMARD) (including investigational agents)
- Prior exposure to a Janus kinase (JAK) inhibitor \> 2 doses
- Total ankylosis of the spine
- Any active/recent infection, as specified in the protocol
- Diagnosis of fibromyalgia
- Any musculoskeletal disorder other than AS that would interfere with assessment of study parameters, as per judgement of investigator
- Note: Prior history of reactive or other types of inflammatory arthritis is permitted if there is documentation of change in diagnosis to AS or additional diagnosis of AS
- Any history of an inflammatory arthritis with onset age before 16 years old
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04483700
Start Date
December 1 2020
End Date
June 1 2024
Last Update
January 11 2021
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