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Monoclonal Antibodies
Secukinumab for Polymyalgia Rheumatica (REPLENISH-EXT Trial)
Parramatta, Australia
Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
who have not been on rescue treatment.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after the first dose of study treatment and within 84 days after the last dose
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
"This trial aims to see if the drug secukinumab is safe for long-term use in patients with polymyalgia rheumatica."
See full description
Who is the study for?
This trial is for patients with Polymyalgia Rheumatica who completed a previous 52-week secukinumab study and had a relapse. They haven't received rescue treatment, and the doctor believes more benefits than risks are present.Check my eligibility
What is being tested?
The trial tests the long-term safety of Secukinumab in treating Polymyalgia Rheumatica. It's an open-label extension study, meaning everyone knows they're getting Secukinumab and it's given over an extended period.See study design
What are the potential side effects?
Secukinumab may cause side effects like infections, allergic reactions, inflammation of nasal passages or upper throat, diarrhea, and possibly others that will be monitored over the course of this long-term study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not received any emergency cancer treatments.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after the first dose of study treatment and within 84 days after the last dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after the first dose of study treatment and within 84 days after the last dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidences of treatment emergent adverse events (AEs) and serious adverse events (SAEs)
Side effects data
From 2023 Phase 4 trial • 196 Patients • NCT0302019910%
Nasopharyngitis
10%
Headache
7%
Upper respiratory tract infection
6%
Arthralgia
1%
Umbilical hernia
1%
Ankle fracture
1%
Asthma
1%
Post procedural haemorrhage
1%
Acute stress disorder
1%
Tibia fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Secukinumab 300 mg - On Treatment
Secukinumab 300 mg - Post Treatment Follow-up
Narrow-band Ultraviolet B (Nb-UVB) - On Treatment
Narrow-band Ultraviolet B (Nb-UVB) - Post Treatment Follow-up
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Secukinumab 300mgExperimental Treatment1 Intervention
All eligible participants will receive secukinumab 300 mg s.c. (2 x 150mg/1mL PFS secukinumab) from baseline and every 4 weeks up to 2 years. The study medication may be modified/adjusted after the initial doses of 300mg s.c. (decreased to 150mg s.c. q4w or increased again from 150mg s.c. q4w to 300mg s.c. q4w) if deemed appropriate by the investigator. Dose modification/adjustment may only occur from Week 24 visit onwards. The modification/adjustment of the study medication will be determined at a site visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Secukinumab
2015
Completed Phase 4
~22170
Find a Location
Closest Location:Clinical Research Institute of Michigan LLC· Saint Clair Shores, MI
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,956 Previous Clinical Trials
4,272,906 Total Patients Enrolled
6 Trials studying Polymyalgia Rheumatica
1,014 Patients Enrolled for Polymyalgia Rheumatica