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Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)
The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica.
Study details:
The study will consist of an up to 4-week screening period, an up to 2-year Treatment Period which includes two Treatment Periods, and a 16-week treatment-free follow-up period (20 weeks post last dose of secukinumab). Treatment period:. There will be two Treatment Periods (TPs): TP1 will be from the first dose administration of secukinumab (Baseline) to Week 24, where visits will occur every 4 weeks, and TP2 will be from post Week 24 visit (post-dose) to up to 2 years.
Participants will return to the study site every 4 weeks from Baseline until Week 24 (Weeks 16 and 20 visits are optional on-site visits and needed when participants are unwilling/uncomfortable to self-administer study treatment at home/offsite), then every 12 weeks afterwards in TP2 for resupply of study medication but may return earlier if needed (i. e. , those participants who are unwilling/uncomfortable to self-administer study treatment can continue to visit site every 4 weeks for drug administration if they wish to do so).
Follow-up period: An EoS visit (20 weeks after last administration of secukinumab) will be done for all participants, regardless of whether they complete the entire study as planned, or they discontinue prematurely.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 50 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-06-28
Primary completion: 2027-12-16
Study completion finish: 2028-02-10
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT06331312
Intervention or treatment
BIOLOGICAL: Secukinumab
Conditions
- • Polymyalgia Rheumatica
Find a site
Closest Location:
Novartis Investigative Site
Research sites nearby
Select from list below to view details:
Novartis Investigative Site
Heidelberg Heights, Victoria, Australia
Novartis Investigative Site
Parramatta, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Secukinumab 300mg
| BIOLOGICAL: Secukinumab
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Incidences of treatment emergent adverse events (AEs) and serious adverse events (SAEs) | The number and percentage of participants with treatment emergent AEs/SAEs will be summarized. No hypothesis testing will be performed. | After the first dose of study treatment and within 84 days after the last dose |
Secondary outcome
Frequently Asked Questions
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