Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis Clinical Trial
Official title:
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
| Verified date | October 2021 |
| Source | Sun Pharmaceutical Industries Limited |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622.
| Status | Terminated |
| Enrollment | 180 |
| Est. completion date | September 3, 2019 |
| Est. primary completion date | February 21, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Hungary | SPARC site 3 | Budapest | |
| Poland | SPARC site 3 | Elblag | |
| Spain | SPARC site 2 | A Coruña | |
| United States | SPARC Site 1 | Middleburg Heights | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Sun Pharmaceutical Industries Limited |
United States, Hungary, Poland, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Assessment of SpondyloArthritis International Society 20 Response Rates | Percentage of subjects who achieve improvement of = 40% and absolute improvement of = 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]). The results for this endpoint is as per the Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates (Full Analysis Set). | Week 24 | |
| Secondary | Assessment of SpondyloArthritis International Society 20 Response Rates | Percentage of subjects who achieve improvement of = 40% and absolute improvement of = 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]). The following are the specific time points at which the outcome measure was assessed and for which data are presented : Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. | Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |