CAIN457C22301: secukinumab vs Pbo in pts with Polymylagia Rheumatica (PMR)
Research type
Research Study
Full title
A randomized, parallel-group, double-blind, placebo-controlled, multicenter Phase III trial to evaluate efficacy and safety of secukinumab administered subcutaneously versus placebo, in combination with a glucocorticoid taper regimen, in patients with polymyalgia rheumatica (PMR)
IRAS ID
1006002
Contact name
Sofia Braud-Perez
Contact email
Sponsor organisation
Novartis Pharma AG
Research summary
The purpose of the study is to demonstrate safety and efficacy of secukinumab (300 mg and 150 mg administered by a subcutaneous (under the skin) injection) for 52 weeks in combination with a steroid dose which is tapered over 24 weeks in adults with polymyalgia rheumatica PMR). PMR is the 2nd most common inflammatory rheumatic condition in people over 50 years old after rheumatoid arthritis. PMR is characterised by pain in the shoulders and pelvic girdle, prolonged morning stiffness and upper extremity pain. Current standard of care is treatment with steroids, a moderate dose to start then gradually reducing dose. Nearly 50% of PMR patients relapse within the first year of treatment.
The trial is a phase III study involving 360 participants; males or females at least 50 years of age who have recently relapsed with PMR (within 12 weeks of starting the study).
Patients will be randomised to one of three treatment arms in a 1:1:1 ratio. Group 1 will receive secukinumab 300 mg in combination a 24 week prednisone taper regimen. Group 2 will receive secukinumab 150 mg in combination a 24 week prednisone taper regimen and Group 3 will receive placebo in combination with a 24 week prednisone taper regimen. Secukinumab has already demonstrated a positive risk/benefit ratio in the treatment of multiple chronic inflammatory diseases including psoriasis.
The study will consist of a screening period, a 56-week treatment period, and a 24 week safety follow up period. Initially patients will be seen once a week then after 4 weeks they will have 4 weekly assessments. At these visits patients will complete health questionnaires and have regular blood tests.
The success of the study will be measured by looking at sustained remission at week at week 52, where patient have no signs or symptoms of PMR and have no elevated levels of inflammatory markers in their blood. The study team will also look at the effect on the patients' quality of life using the health questionnaires.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0106
Date of REC Opinion
25 Aug 2023
REC opinion
Further Information Favourable Opinion