Study on the Effectiveness and Safety of Secukinumab for Patients with New-Onset Giant Cell Arteritis in Clinical Remission

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What is this study about?

This clinical trial is focused on studying a condition called Giant Cell Arteritis (GCA), which is an inflammation of the blood vessels, often affecting the arteries in the head. The study is investigating the effectiveness and safety of a treatment called secukinumab, also known by its code name AIN457. Secukinumab is given as an injection under the skin and is being compared to a placebo. The purpose of the study is to see if secukinumab can delay the return of symptoms in patients with new-onset GCA who are currently in remission, meaning their symptoms are not active.

Participants in the study will receive either secukinumab or a placebo, along with a standard treatment involving a medication called glucocorticoid, which helps reduce inflammation. The study will follow participants over a period to monitor their health and any changes in their condition. The main goal is to determine how long it takes for symptoms of GCA to return, if they do, while also assessing the overall health and quality of life of the participants.

Throughout the study, researchers will keep track of any side effects and how well participants tolerate the treatment. The study aims to provide valuable information on whether secukinumab can be a beneficial treatment option for people with GCA, potentially offering a new way to manage this condition and improve patient outcomes.

1 Joining the study

Participation begins after signing an informed consent form. This confirms understanding of the study and agreement to follow its requirements.

Eligibility includes being at least 50 years old, having a recent diagnosis of giant cell arteritis (GCA), and being in clinical remission.

2 Baseline visit

The baseline visit involves confirming the diagnosis of GCA, which may include a temporal artery biopsy or imaging studies.

Participants must be on a stable dose of prednisolone or equivalent glucocorticoid, ranging from 20-60 mg per day.

3 Randomization and treatment

Participants are randomly assigned to receive either secukinumab 300 mg or a placebo. Both are administered as a subcutaneous injection.

The treatment is combined with a tapering regimen of prednisolone or an equivalent glucocorticoid, following treatment guidelines.

4 Monitoring and assessments

Regular assessments are conducted to monitor disease activity, quality of life, and any side effects.

Primary focus is on the time to first clinical relapse of GCA from the baseline.

5 End of study

The study aims to evaluate the proportion of participants in sustained clinical remission at Week 52.

Secondary assessments include changes in disease activity, quality of life, and the cumulative dose of prednisolone or equivalent.

Who Can Join the Study?

You must sign a form to show you agree to join the study.
You need to be able to understand and talk with the study team and follow the study rules.
You must be a man or woman who is at least 50 years old.
You should have a new diagnosis of Giant Cell Arteritis (GCA), which means it was diagnosed within 6 weeks of your first study visit. This includes:
- Being at least 50 years old when the disease started.
- Having a history of high levels of certain blood tests called Erythrocyte Sedimentation Rate (ESR) or C-reactive protein (CRP), which are linked to active GCA.
- Having clear symptoms of GCA, like a new headache, tenderness in the scalp or temple area, vision loss due to lack of blood flow, or unexplained pain in the mouth or jaw when chewing. You might also have symptoms of polymyalgia rheumatica (PMR), which is pain in the shoulders or hips with morning stiffness, or symptoms of poor blood flow in the limbs, like pain when walking.
- Having a temporal artery biopsy that shows signs of GCA, or having evidence of blood vessel inflammation in the head or other areas shown by imaging tests like ultrasound, magnetic resonance angiography (MRA), computed tomography angiography (CTA), or positron emission tomography – computed tomography (PET-CT).
You must be in a state of no symptoms (clinical remission) at the start of the study.
You should not have any relapses of GCA at the start of the study.
You need to be taking a daily dose of prednisolone or a similar medication, between 20-60 mg, or an equivalent dose of other glucocorticoids (GCs) at the start of the study.

Who Cannot Join the Study?

Patients who are not in clinical remission. This means their symptoms are not currently under control.
Patients who are not eligible for treatment with glucocorticoid-monotherapy. Glucocorticoids are a type of medication used to reduce inflammation.
Patients who have not been diagnosed with new-onset Giant Cell Arteritis (GCA). This is a condition that affects certain blood vessels.
Patients who are not able to follow the prednisolone taper regimen. Prednisolone is a medication used to treat inflammation, and a taper regimen means gradually reducing the dose.
Patients who are part of a vulnerable population. This refers to groups of people who may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Krankenhaus Porz Am Rhein gGmbH	Cologne	Germany
University Hospital Jena KöR	Jena	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Barmherzige Brueder Trier gGmbH	Trier	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH	Ludwigshafen Am Rhein	Germany
Johannes Wesling Klinikum Minden	Minden	Germany
Rheumatologische Schwerpunktpraxis	Berlin	Germany
BIOMEDRO Biomedizinische Forschung und Entwicklung GmbH	Bad Doberan	Germany
Marienhaus Klinikum Mainz GmbH	Mainz	Germany
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
St.-Josef-Stift	Sendenhorst	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Kerckhoff-Klinik GmbH	Bad Nauheim	Germany
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr	Herne	Germany
Staedtisches Klinikum Dresden	Dresden	Germany
Rheumapraxis Heidelberg	Heidelberg	Germany
Medicover GmbH	Oldenburg In Holstein	Germany
Mpwlfhzftpndxhovwhtmmfbdxm Hjfjrzpitwpjxckp	Halle (Saale)	Germany
Rokpkg Pdwopq Bdssxy	Berlin	Germany
Hnxzuf Ftlxcornuz Vvsszflipbeohvviz Gpet	Gommern	Germany
Mxynadxpl Mwusnne glynw	Munich	Germany
Uafemkjgjt Hcynqbxp Ceusbpf	Cologne	Germany
Updhnwuxsqnlqsgsungno Drxwuobtzal Alm	Duesseldorf	Germany
Ulzuafhwjnylundebubdr Wlwgyhbof Aty	Wuerzburg	Germany
Idmmyoqbirbkcfljdvco Gxov	Berlin	Germany
Rzwskrpxthhnoilk Shyvzujsbvajtqusd Dyt Jniyct Wuasns	Rendsburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	21.09.2022

Trial locations

Investigated drugs:

Secukinumab

Secukinumab is a medication used in this trial to help prevent the return of symptoms in patients with a condition called giant cell arteritis (GCA). It is given as an injection under the skin. The goal is to see if it can delay the time until the disease comes back in patients who are already in remission.

Prednisolone is a type of medication known as a glucocorticoid. It is used in this trial as part of a treatment plan to help manage inflammation and symptoms in patients with giant cell arteritis. It is typically given in a tapering regimen, meaning the dose is gradually reduced over time according to treatment guidelines.

Investigated diseases:

Giant cell arteritis

Giant Cell Arteritis – Giant Cell Arteritis is an inflammatory disease that affects the large and medium-sized arteries, primarily in the head. It often causes headaches, scalp tenderness, jaw pain, and vision problems. The inflammation can lead to narrowing or blockage of the affected arteries, reducing blood flow. This condition is more common in older adults and can progress to cause serious complications if not managed. Symptoms may fluctuate, with periods of remission and relapse. The exact cause of Giant Cell Arteritis is not fully understood, but it is believed to involve an abnormal immune response.

Trial ID:

2024-512856-40-00

Protocol code:

CAIN457R1DE01

NCT ID:

NCT05380453

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Secukinumab for Patients with New-Onset Giant Cell Arteritis in Clinical Remission

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