Last updated: January 7, 2021
Sponsor: Gilead Sciences
Overall Status: Trial Not Available
Phase
3
Condition
Arthritis And Arthritic Pain
Musculoskeletal Diseases
Ankylosing Spondylitis
Treatment
N/AClinical Study ID
NCT04483700
GS-US-433-5307
2019-004279-38
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
- Ambulatory male or female, ≥ 18 years of age (≥ 20 years of age in Japan) on the dayof signing initial informed consent
- Have an established diagnosis of radiographic axial spondyloarthritis (SpA)/ankylosing spondylitis (AS) by a rheumatologist (or other specialist with expertisediagnosing AS)
- Meet Assessment of SpondyloArthritis international Society (ASAS) classificationcriteria for axial SpA with radiographic sacroiliitis on imaging at screening asfollows:
- 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, heelenthesitis, uveitis anterior, dactylitis, psoriasis, inflammatory bowel disease,good response to nonsteroidal anti-inflammatory drugs (NSAIDs), family history ofSpA, historically positive human leukocyte antigen B27 (HLA-B27), elevatedC-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 ≥ 2weeks each (a total duration of NSAID trial ≥ 4 weeks) or intolerance to ≥ 2 NSAIDsfor the treatment of AS
- If using allowed conventional synthetic disease-modifying antirheumatic drug (csDMARD), NSAID, or corticosteroid therapy, must have been on stable doses (asoutlined in protocol) prior to Day 1
Exclusion
Key Exclusion Criteria:
- 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 ofstudy parameters, as per judgement of investigator
- Note: Prior history of reactive or other types of inflammatory arthritis ispermitted if there is documentation of change in diagnosis to AS or additionaldiagnosis of AS
- Any history of an inflammatory arthritis with onset age before 16 years old Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Study Start date:
December 01, 2020
Estimated Completion Date:
June 30, 2024