Efficacy and Safety Study of SUNPG1622
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/17/2019 |
| Start Date: | November 6, 2017 |
| End Date: | December 31, 2020 |
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
This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the
efficacy and safety of SUNPG1622.
efficacy and safety of SUNPG1622.
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
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