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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 November 2021 |
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Main ID: |
NCT02980705 |
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Date of registration:
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30/11/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and Safety Study of SUNPG1622
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Scientific title:
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A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis |
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Date of first enrolment:
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November 6, 2017 |
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Target sample size:
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180 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02980705 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Hungary
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Poland
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Spain
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject has provided informed written consent
- 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:
- Subjects with known diagnosis of fibromyalgia or complex regional pain syndromes
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis
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Intervention(s)
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Drug: Placebo dose
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Drug: SUNPG1622 I dose
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Primary Outcome(s)
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Assessment of SpondyloArthritis International Society 20 Response Rates
[Time Frame: Week 24]
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Secondary Outcome(s)
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Assessment of SpondyloArthritis International Society 20 Response Rates
[Time Frame: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24]
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Secondary ID(s)
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CLR_16_22
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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