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Monoclonal Antibodies

Secukinumab for Polymyalgia Rheumatica (REPLENISH Trial)

Verified 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

Male or non-pregnant, non-lactating female participants at least 50 years of age

Participants must have a history of being treated for at least 8 consecutive weeks with prednisone (≥ 10 mg/day or equivalent) at any time prior to screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

REPLENISH Trial Summary

This trial tests a drug to treat a relapsed form of arthritis using both high and low doses, with prednisone to reduce inflammation.

Who is the study for?

Adults over 50 with Polymyalgia Rheumatica (PMR) who've relapsed after trying to reduce their prednisone dosage can join. They must have been on prednisone for at least 8 weeks before and had a PMR flare-up while tapering off the drug within the last 12 weeks.Check my eligibility

What is being tested?

The trial is testing Secukinumab, given as an injection under the skin, in two different doses (300 mg and 150 mg), compared to a placebo. All treatments are combined with a decreasing dose of prednisone over half a year.See study design

What are the potential side effects?

Secukinumab may cause infections, allergic reactions at the injection site, headache, high blood pressure, fungal infections in mouth or throat, diarrhea, runny nose or sore throat.

REPLENISH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a man or a woman not pregnant or breastfeeding, and I am 50 years old or older.

Select...

I have been treated with prednisone or a similar medication for at least 8 weeks before.

Select...

I had a PMR flare-up while reducing my prednisone dose to 5 mg/day or more in the last 3 months.

REPLENISH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of participants achieving sustained remission

Secondary outcome measures

Adjusted annual cumulative glucocorticoid (GC) dose adjusted by duration of study follow-up

Change in FACIT-Fatigue Score

Change in HAQ-DI score

+2 more

REPLENISH Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Secukinumab 300 mgExperimental Treatment1 Intervention

randomized in 1:1:1 ratio every 4 weeks

Group II: Secukinumab 150 mgExperimental Treatment1 Intervention

randomized in 1:1:1 ratio every 4 weeks

Group III: Placebo to secukinumabPlacebo Group1 Intervention

randomized in 1:1:1 ratio every 4 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Secukinumab 300 mg

2016

Completed Phase 4

~480

Secukinumab 150 mg

2016

Completed Phase 4

~260

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,859 Previous Clinical Trials

4,197,884 Total Patients Enrolled

6 Trials studying Polymyalgia Rheumatica

923 Patients Enrolled for Polymyalgia Rheumatica

Media Library

Secukinumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05767034 — Phase 3

Polymyalgia Rheumatica Research Study Groups: Secukinumab 300 mg, Secukinumab 150 mg, Placebo to secukinumab

Polymyalgia Rheumatica Clinical Trial 2023: Secukinumab Highlights & Side Effects. Trial Name: NCT05767034 — Phase 3

Secukinumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05767034 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Secukinumab 150 mg been granted approval from the Federal Drug Administration?

"Secukinumab 150 mg has been deemed a 3 on the safety scale, as there is ample evidence of efficacy and multiple studies that have indicated it to be safe."

Answered by AI

How many clinical sites are conducting this research trial?

"Currently, the program is operating from 4 distinct locations across Australia and Switzerland. These include Hobart, Parramatta, St Gallen and several other cities; hence it may be beneficial to opt for a site near you in order to reduce transit time when taking part."

Answered by AI

Are there any available vacancies in this medical trial?

"Based on the information accessible from clinicaltrials.gov, this trial is currently sourcing participants since its initial posting date of March 22nd 2023 and most recent update being April 12th 2023."

Answered by AI

How many individuals have been enlisted to participate in this research project?

"Correct. Clinicaltrials.gov states that this medical trial, which had its inception on March 22nd of 2023, is presently recruiting participants. A total of 360 patients need to be enrolled from 4 different research institutions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)

2023. "Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05767034.

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