Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
180 participants
INTERVENTIONAL
2017-11-06
2019-09-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SUNPG1622 I
SUNPG1622 I dose
SUNPG1622 I dose
Injection
Placebo
Placebo dose
Placebo dose
Injection
Interventions
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SUNPG1622 I dose
Injection
Placebo dose
Injection
Eligibility Criteria
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Inclusion Criteria
* Subject is ≥ 18 years of age at time of Screening
* Subject must be on a stable dose of NSAID for ≥ 2 weeks prior to initiation of investigational product
* Subject has a negative test for TB within 4 weeks before initiating IMP
Exclusion Criteria
* Active uveitis or symptomatic inflammatory bowel disease requiring therapy at screening
* Radiographic evidence of total ankylosis of the spine
* Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pre-treatment condition
18 Years
ALL
No
Sponsors
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Sun Pharmaceutical Industries Limited
INDUSTRY
Responsible Party
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Locations
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SPARC Site 1
Middleburg Heights, Ohio, United States
SPARC site 3
Budapest, , Hungary
SPARC site 3
Elblag, , Poland
SPARC site 2
A Coruña, , Spain
Countries
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References
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Peters E, Chou RC, Rozzo SJ, Yao SL, Fructuoso FJG. A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of Tildrakizumab Efficacy and Safety in Patients With Active Ankylosing Spondylitis. J Clin Rheumatol. 2023 Aug 1;29(5):223-229. doi: 10.1097/RHU.0000000000001973. Epub 2023 May 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLR_16_22
Identifier Type: -
Identifier Source: org_study_id