CLR_16_22_Ph2 Safety&Efficacy Tildrakizumab in Pts with AS or nr-axSA
Research type
Research Study
Full 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
IRAS ID
222343
Contact name
Karen Douglas
Contact email
Sponsor organisation
SUN Pharmaceuticals Global FZE
Eudract number
2016-003936-19
Duration of Study in the UK
3 years, 9 months, 6 days
Research summary
Tildrakizumab is a humanised immunoglobulin (IgG1) antibody. It binds to a protein in the immune system to reduce inflammation in certain immune mediated conditions.
Clinically effective doses of the study drug tildrakizumab has shown to be effective in inflammatory conditions of immune dysfunction such as chronic plaque psoriasis (PsO). There is evidence to suggest these doses would potentially also benefit patients with related conditions such as Ankylosing Spondylitis (AS) and non radiographic axial Spondyloarthritis (nr-axSpA). This is the first clinical trial to test this drug in these indications so the benefits have currently not been proven. However as the mechanism to reduce inflammation for PsO is the same for AS and nr-axSpA it is expected to produce positive results. The proposed dose of 200mg every four weeks is considered safe and will effectively suppress the mechanism of disease activity in AS and nr-axSpA. The reduction in disease activity in participants with AS or nr-axSpA will be determined by the Assessment of SpondyloArthritis international Society (ASAS) criteria defined as ≥ 40% improvement in 3 of 4 assessment domains (ASAS40) responder rate, compared to placebo. The study will also provide safety and tolerability information for tildrakizumab in these patient populations.
Male or female participants ≥ 18 years of age that confirm an interest will be assesed against the eligibility criteria for suitability. Approximately 180 subjects (~90 subjects with Ankylosing Spondylitis and ~90 subjects with Non-Radiographic Axial Spondyloarthritis) will take part in the study at 55 research sites in 7 countries across the EU and United States. In the UK there will be 7 Trusts participating and approximately 30 patients recruited. The participants will need to visit the research site about 19 times over a period of 72 weeks. The study will last approximately 4years.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
17/WM/0060
Date of REC Opinion
29 Mar 2017
REC opinion
Further Information Favourable Opinion