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Monoclonal Antibodies

Secukinumab for Polymyalgia Rheumatica (REPLENISH-EXT Trial)

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."

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.
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.
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 below
Select...
I have not received any emergency cancer treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after the first dose of study treatment and within 84 days after the last dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and after the first dose of study treatment and within 84 days after the last dose for reporting.

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 2019 Phase 4 trial • 102 Patients • NCT03055494
19%
Nasopharyngitis
13%
Upper respiratory tract infection
7%
Back pain
7%
Cough
6%
Headache
4%
Urinary tract infection
4%
Anxiety
4%
Rhinorrhoea
4%
Muscle strain
4%
Postoperative wound infection
4%
Sinus congestion
4%
Conjunctivitis
4%
Pharyngitis streptococcal
4%
Gastroenteritis viral
4%
Diarrhoea
4%
Fatigue
4%
Aphthous ulcer
4%
Influenza
4%
Fall
2%
Ligament sprain
2%
Insomnia
2%
Oropharyngeal pain
2%
Hypoglycaemia
2%
Nasal congestion
2%
Tinea pedis
2%
Tooth abscess
2%
Actinic keratosis
2%
Irritability
2%
Sneezing
2%
Blood pressure increased
2%
Wound dehiscence
2%
Post procedural contusion
2%
Road traffic accident
2%
Pruritus
2%
Pruritus generalised
2%
Dermatitis
2%
Dehydration
2%
Tonsillitis
2%
Ligament rupture
2%
Squamous cell carcinoma
2%
Productive cough
2%
Decreased appetite
2%
Intertrigo
2%
Sinusitis
2%
Palpitations
2%
Glossodynia
2%
Cyst
2%
Cystitis
2%
Otitis externa candida
2%
Peripheral swelling
2%
Hordeolum
2%
Otitis media
2%
Ear pain
2%
Anaemia
2%
Cellulitis
2%
Suicidal ideation
2%
Lacrimation increased
2%
Muscle spasms
2%
Ear discomfort
2%
Pyrexia
2%
Abdominal distension
2%
Nausea
2%
Toothache
2%
Myalgia
2%
Influenza like illness
2%
Rash
2%
Seborrhoeic dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Secukinumab 300 mg
Placebo/Secukinumab 300 mg

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
~22760

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,913 Previous Clinical Trials
4,252,863 Total Patients Enrolled
6 Trials studying Polymyalgia Rheumatica
983 Patients Enrolled for Polymyalgia Rheumatica
~200 spots leftby Feb 2028
Unbiased ResultsWe believe in providing patients with all the options.
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Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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