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Study on Long-Term Safety of Secukinumab for Patients with Polymyalgia Rheumatica

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term safety and tolerability of a medication called secukinumab in individuals with Polymyalgia Rheumatica (PMR). PMR is a condition that causes muscle pain and stiffness, especially in the shoulders. The medication, secukinumab, is given as an injection under the skin and is being tested to see how safe it is for long-term use in people with this condition.

The purpose of the study is to monitor any side effects or serious side effects that may occur while using secukinumab. Participants in this study have previously completed a 52-week treatment period in an earlier study and have experienced a return of symptoms during a follow-up period without treatment. This study aims to provide further information on the safety of continuing secukinumab treatment over a longer period.

Participants will receive secukinumab injections and will be monitored for any adverse effects. The study will help determine if the benefits of using secukinumab outweigh any potential risks for individuals with PMR. The study is expected to continue until 2028, providing valuable data on the long-term use of this medication.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after completing a 52-week treatment period in a previous study of secukinumab for polymyalgia rheumatica (PMR).

    Eligibility requires experiencing a relapse during the treatment-free follow-up period of the previous study without receiving rescue treatment.

  2. Step 2

    Treatment administration

    The medication used in this study is secukinumab, administered subcutaneously, which means it is injected under the skin.

    The study aims to evaluate the long-term safety and tolerability of secukinumab in patients with PMR.

  3. Step 3

    Monitoring and evaluation

    The primary objective is to monitor the occurrence of adverse events (AEs) and serious adverse events (SAEs) throughout the study.

    Regular assessments will be conducted to ensure the safety and well-being of participants.

  4. Step 4

    Study duration

    The estimated end date for the study is May 8, 2028.

    Participants will be involved in the study until this date, unless otherwise specified by the study protocol.

Who can join the trial?

7 criteria

  • Participants must have completed a 52-week treatment period in a previous Novartis study for **Polymyalgia Rheumatica (PMR)**. PMR is a condition that causes muscle pain and stiffness.
  • Participants must have experienced a **relapse** during the treatment-free follow-up period of the previous study. A relapse means the return of symptoms of PMR or signs of a new condition called **Giant Cell Arteritis (GCA)**, which requires changes in treatment.
  • Participants must not have been on **rescue treatment**. Rescue treatment is an emergency treatment given when symptoms worsen.
  • The participant should potentially benefit from the study medication, **secukinumab**, and the benefits should outweigh any risks, as judged by the study doctor.
  • Both male and female participants are eligible.
  • The study includes participants from certain age groups, typically adults and older adults.
  • The study may include individuals considered part of a **vulnerable population**, which means they might need special protection or care.

Who cannot join the trial?

4 criteria

  • Patients who have a different condition than Polymyalgia Rheumatica cannot participate.
  • Individuals who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
  • Both males and females are eligible, so gender is not a reason for exclusion.
  • Individuals who are considered part of a vulnerable population may not be eligible. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

Secukinumab is a medication used in this clinical trial. It is administered through an injection under the skin. The purpose of using secukinumab in this study is to evaluate its long-term safety and how well it is tolerated by patients with polymyalgia rheumatica, a condition that causes muscle pain and stiffness.

What is already known about the treatment

Secukinumab – Secukinumab is administered as an injection under the skin, commonly known as a subcutaneous injection. It is currently being studied in clinical trials for its long-term safety and tolerability in treating polymyalgia rheumatica, a condition characterized by muscle pain and stiffness. The medication works by targeting and inhibiting a specific protein in the immune system called interleukin-17A, which plays a role in inflammation. Secukinumab is classified as a biologic medication, specifically a monoclonal antibody, and is used to reduce inflammation and alleviate symptoms associated with autoimmune conditions.

Investigated diseases

Polymyalgia Rheumatica – Polymyalgia Rheumatica is an inflammatory disorder that primarily affects older adults, causing muscle pain and stiffness, especially in the shoulders and hips. The symptoms often appear suddenly and are more severe in the morning or after periods of inactivity. As the condition progresses, individuals may experience fatigue, mild fever, and a general feeling of being unwell. The stiffness and pain can lead to difficulty in performing daily activities, such as getting dressed or rising from a chair. Although the exact cause is unknown, it is believed to involve an immune system response. The condition can last for several months to a few years, with symptoms fluctuating in intensity.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508077-85-00Protocol codeCAIN457C22301E1Estimated enrolment349 patientsSponsorNovartis Pharma AG

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