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Secukinumab for Giant Cell Arteritis

Verified Trial

Phase 3

Waitlist Available

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 patients at least 50 years of age

Patients to meet definition of new-onset GCA or relapsing GCA

Must not have

Women of childbearing potential not using effective contraception

Previous exposure to specific biologic drugs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new drug to see if it's effective and safe for people with a disease that causes inflammation in the arteries.

Who is the study for?

This trial is for patients at least 50 years old with Giant Cell Arteritis (GCA), who can be treated with prednisone. They must understand the study and follow its requirements, not be pregnant or breastfeeding, use effective contraception if applicable, and may continue using methotrexate under certain conditions. Exclusions include previous biologic drug exposure, significant health issues like uncontrolled diabetes or heart failure, recent blood donation, substance abuse history within six months, and certain infections.

What is being tested?

The trial tests the effectiveness and safety of Secukinumab (at doses of either 300 mg or 150 mg) versus a placebo in managing GCA symptoms while tapering off glucocorticoids like prednisone. It's a phase III study where participants are randomly assigned to receive either the medication or a placebo alongside their standard treatment regimen.

What are the potential side effects?

Secukinumab could potentially cause side effects such as infections due to immune system suppression, allergic reactions at injection sites, headache, upper respiratory tract infections, diarrhea and nausea. The exact side effect profile will be further evaluated during this clinical trial.

Eligibility Criteria

Inclusion Criteria

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

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

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I have been diagnosed with new or relapsing Giant Cell Arteritis.

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My current condition can be managed with a specific dose of prednisone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a woman who can have children and am not using birth control.

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I have been treated with specific biologic drugs before.

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I have a history of liver disease, heart issues, blood vessel inflammation, or ongoing inflammatory diseases.

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I do not have uncontrolled high blood pressure, heart failure, or diabetes.

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I have a history of serious liver disease or damage.

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I have a history of chronic or recurrent infections, including tuberculosis.

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I have been diagnosed with HIV, hepatitis B, or hepatitis C.

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I have not had cancer or lymphoproliferative disease in the last 5 years.

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My condition is getting worse and not under control.

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I have not lost or donated more than 400 mL of blood in the last 8 weeks.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in FACIT-Fatigue Score

Change in GlucocorticoidToxicity Index (GTI)

Change in SF-36 score (PCS)

+4 more

Side effects data

From 2018 Phase 4 trial • 91 Patients • NCT02690701

18%

Nasopharyngitis

11%

Upper respiratory tract infection

Arthralgia

Cough

Diarrhoea

Dizziness

Headache

Bronchitis

Sinusitis

Upper limb fracture

Muscular weakness

Aortic stenosis

Abdominal pain

Rib fracture

100%

80%

60%

40%

20%

Study treatment Arm

Total

Placebo/Secukinumab 300 mg

Secukinumab 300 mg

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Secukinumab 300 mgExperimental Treatment1 Intervention

Secukinumab 300 mg s.c. at BSL, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4. Secukinumab will be given in combination with a specified 26-week prednisone taper regimen. After the 26-week prednisone taper, participants will continue to receive placebo to prednisone until Week 52.

Group II: Secukinumab 150 mgExperimental Treatment1 Intervention

Secukinumab 150 mg s.c. at BSL, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4. Secukinumab will be given in combination with a specified 26-week prednisone taper regimen. After the 26-week prednisone taper, participants will continue to receive placebo to prednisone until Week 52.

Group III: PlaceboPlacebo Group1 Intervention

Placebo to secukinumab s.c. at BSL, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4. Placebo will be given in combination with a specified 52-week prednisone taper regimen.

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