Phase
Condition
Iritis
Uveitis
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects must have a documented diagnosis of adult-onset axial Spondyloarthritis (axSpA) with at least 3 months' symptom duration and meet the Assessment ofSpondyloArthritis International Society (ASAS) criteria
- Subjects must have active disease at Screening as defined by
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4
- Spinal pain >= 4 on a 0 to 10 Numerical Rating Scale (NRS; from BASDAI item 2)
- Nonradiographic (Nr)-axSpA subjects must either have C-reactive protein (CRP) > upperlimit of normal (ULN) and /or current evidence of sacroiliitis on magnetic resonanceimaging (MRI) (no confirmation by central reading) as defined by ASAS criteria
- Ankylosing spondylitis (AS) subjects must have evidence of sacroiliitis on x-raymeeting the modified New York (mNY) classification criteria according to theInvestigator
- Subjects must have a documented history of Anterior Uveitis (AU) diagnosed by anophthalmologist and have at least 2 AU flares in the past, of which at least 1 AUflare was in the last 12 months prior to Baseline
Exclusion
Exclusion Criteria:
- Other inflammatory arthritis
- Secondary, noninflammatory condition that, in the Investigator's opinion, issymptomatic enough to interfere with evaluation of the effect of study drug on thesubject's primary diagnosis of axial spondyloarthritis (axSpA)
- Any history of uveitis except for Anterior Uveitis (AU) associated with axSpA
- Any condition or complicating factor that may interfere with the AU assessment
- Retisert® or Iluvien® (glucocorticosteroid implant) within 3 years prior to theBaseline Visit or has had complications related to the device
- Subject has had Retisert or Iluvien (glucocorticosteroid implant) removed within 90days prior to the Baseline Visit
- Intraocular or periocular corticosteroids within 90 days prior to the Baseline visit
- Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline Visit
- Cyclophosphamide within 30 days prior to the Baseline Visit
- Intravitreal methotrexate (MTX) within 90 days prior to the Baseline Visit
- Intravitreal anti-vascular endothelial growth factor (VEGF) therapy
Study Design
Connect with a study center
As0007 101
Brno,
CzechiaSite Not Available
As0007 103
Brno,
CzechiaSite Not Available
As0007 107
Brno,
CzechiaSite Not Available
As0007 108
Ostrava,
CzechiaSite Not Available
As0007 109
Pardubice,
CzechiaSite Not Available
As0007 105
Praha,
CzechiaSite Not Available
As0007 102
Praha 2,
CzechiaSite Not Available
As0007 304
Frankfurt,
GermanySite Not Available
As0007 301
Freiburg,
GermanySite Not Available
As0007 303
Muenster,
GermanySite Not Available
As0007 302
Munich,
GermanySite Not Available
As0007 302
München,
GermanySite Not Available
As0007 303
Münster,
GermanySite Not Available
As0007 401
Amsterdam,
NetherlandsSite Not Available
As0007 506
Bialystok,
PolandSite Not Available
As0007 506
Białystok,
PolandSite Not Available
As0007 510
Lublin,
PolandSite Not Available
As0007 509
Poznan,
PolandSite Not Available
As0007 509
Poznań,
PolandSite Not Available
As0007 511
Poznań,
PolandSite Not Available
As0007 502
Torun,
PolandSite Not Available
As0007 502
Toruń,
PolandSite Not Available
As0007 501
Warszawa,
PolandSite Not Available
As0007 505
Warszawa,
PolandSite Not Available
As0007 507
Wroclaw,
PolandSite Not Available
As0007 504
Wrocław,
PolandSite Not Available
As0007 507
Wrocław,
PolandSite Not Available
As0007 508
Wrocław,
PolandSite Not Available
As0007 604
Barcelona,
SpainSite Not Available
As0007 601
Córdoba,
SpainSite Not Available
As0007 603
Madrid,
SpainSite Not Available

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