Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A trial of prednisolone in combination with SPI-62 in participants with polymyalgia rheumatica (PMR)

This clinical trial is designed to investigate a new medication, SPI-62, when given together with prednisolone, which is a standard treatment for polymyalgia rheumatica (PMR). PMR is a condition that causes pain and stiffness in the muscles, often in the shoulders, neck, and hips. This early-stage study, sometimes called a Phase 1 trial, is mainly focused on checking if the new medicine, SPI-62, is safe and how it behaves in the body when combined with prednisolone. It will help researchers understand if this new treatment approach could be a an option for individuals with PMR in the future. Anyone aged 18 and over can potentially take part, regardless of their gender.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Sparrow Pharmaceuticals Inc.

Enrolment target

Start

20 Feb 2024

polymyalgia rheumatica

What is this study about?

This study is investigating a new treatment for polymyalgia rheumatica, often shortened to PMR. PMR is a health condition that causes aching and stiffness in your muscles, especially around your shoulders, neck, and hips. It's usually treated with a medicine called prednisolone, which is a type of steroid.

In this trial, doctors are looking at a new medicine called SPI-62. They want to see what happens when SPI-62 is given alongside prednisolone. This is an early-stage study, which means it's generally about checking if the new medicine is safe and how your body reacts to it. It's a first step to understand if this new combination could be helpful for people with PMR in the future.

Learning more about SPI-62 and how it works with prednisolone is an important step in finding new and potentially better ways to manage PMR. The information gathered from this study will help researchers decide if further, larger studies should be done.

Key takeaways

This study is testing a new medicine (SPI-62) for PMR.
SPI-62 is given alongside prednisolone, a common PMR treatment.
It's an early-stage study focusing on safety and how the medicine works.
Anyone 18 years or older, with PMR, may be eligible.
Participation involves regular clinic visits and health checks.
You can stop participating at any time.

Who may be eligible?

This study is open to both men and women who are 18 years old or older. The researchers are looking for people who have polymyalgia rheumatica (PMR).

To join, you would need to meet certain other health requirements that the study doctors will check. These are in place to make sure the study is safe for you and that the results are clear.

For example, if you have certain other medical conditions or are taking specific medications, you might not be able to take part. The study team will discuss all of these details with you during a screening visit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have polymyalgia rheumatica (PMR)?
Are you able to attend regular appointments at the study clinic?
Are you willing to take study medication and have health checks?
Are you generally in good health, apart from your PMR, or are any other health conditions well-managed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have several visits to the study clinic. During these visits, the study team would give you the study medication (prednisolone and SPI-62). They would also carry out various tests and checks, such as blood tests, to see how the medication is affecting you and to ensure your safety.

The study would involve regular appointments over a certain period, which the study team will explain in detail. After you finish taking the medication, there would probably be some follow-up visits or phone calls to see how you are doing. The exact total time you would be involved in the study would be explained clearly before you agree to participate.

Potential risks and benefits

Taking part in this study means you could be among the first to try a new treatment combination for PMR, which could potentially help researchers find better ways to manage the condition in the future. However, there might also be risks, as with any new medicine. SPI-62 could have side effects, and the combination with prednisolone might also lead to unexpected reactions. All potential benefits and risks will be thoroughly explained to you, and you have the right to leave the study at any time, for any reason, without it affecting your usual care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is polymyalgia rheumatica (PMR)?

PMR is a condition that causes regular pain and stiffness, most often in the shoulders, neck, and hips. It's more common in older adults.

What is prednisolone?

Prednisolone is a type of steroid medicine often used to treat conditions like PMR because it helps reduce inflammation and pain.

What is SPI-62?

SPI-62 is a new investigational medication that is being tested to see if it can help with PMR when used with prednisolone. It is not currently available outside of this study.

Why is this called a Phase 1 study?

Phase 1 studies are early-stage trials that mainly focus on checking if a new medicine is safe and finding the right dose. They are a first step before larger studies.

Will I get paid to take part?

Payment for participation varies between studies. The research team will be able to tell you if there is any compensation for your time or travel expenses.