Secukinumab for Polymyalgia Rheumatica

(REPLENISH Trial)

Recruiting at 146 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novartis Pharmaceuticals

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests secukinumab injections for adults with relapsed Polymyalgia Rheumatica (PMR). The treatment aims to reduce inflammation by calming the immune system. Researchers will compare the effectiveness and safety of secukinumab over a period of time. Secukinumab has been shown to improve signs and symptoms in various inflammatory conditions such as ankylosing spondylitis and psoriatic arthritis in multiple clinical trials.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

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.

Inclusion Criteria

You have been diagnosed with polymyalgia rheumatica using specific guidelines from the American College of Rheumatology and the European League Against Rheumatism.

I am taking a steroid medication for my condition, between 7.5 and 25 mg/day.

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

Exclusion Criteria

I have a condition like rheumatoid arthritis or lupus.

My underactive thyroid is not properly managed.

I have been treated with drugs targeting IL-17 for my condition.

Treatment Details

Interventions

• Placebo to Secukinumab (Other)
• Secukinumab (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Secukinumab 300 mg Experimental Treatment 1 Intervention

randomized in 1:1:1 ratio every 4 weeks

Group II: Secukinumab 150 mg Experimental Treatment 1 Intervention

randomized in 1:1:1 ratio every 4 weeks

Group III: Placebo to secukinumab Placebo Group 1 Intervention

randomized in 1:1:1 ratio every 4 weeks

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD