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Secukinumab for Giant Cell Arteritis

Verified Trial
Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be able to understand and communicate with the investigator and comply with the requirements of the study
Male or non-pregnant, non-lactating female patients at least 50 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 can understand and follow the study's requirements.
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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 was diagnosed with GCA recently and meet all the specific criteria.
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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.
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I am taking MTX (up to 25 mg/week) and can follow specific instructions for it.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
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
20%
Nasopharyngitis
13%
Upper respiratory tract infection
11%
Arthralgia
7%
Diarrhoea
7%
Bronchitis
2%
Muscular weakness
2%
Rib fracture
2%
Aortic stenosis
2%
Abdominal pain
2%
Upper limb fracture
2%
Dizziness
2%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo/Secukinumab 300 mg
Secukinumab 300 mg
Total

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

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,853 Previous Clinical Trials
4,197,129 Total Patients Enrolled
6 Trials studying Giant Cell Arteritis
934 Patients Enrolled for Giant Cell Arteritis

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04930094 — Phase 3
Giant Cell Arteritis Research Study Groups: Secukinumab 300 mg, Placebo, Secukinumab 150 mg
Giant Cell Arteritis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04930094 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04930094 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you tell me how many medical facilities are involved in this research project?

"This study is being conducted in 16 hospitals, with sites in cities such as Detroit, Los Angeles, Sherbrooke and 14 additional locations. If you are selected to participate, it would be ideal if you could choose a site near you to limit travel difficulties."

Answered by AI

Are there any empty slots in this trial that a patient could fill?

"Yes, this trial is still open and recruiting patients. According to the clinicaltrials.gov website, the study was first posted on October 6th, 2021 and last updated on November 10th, 2022."

Answered by AI

How many people are taking part in this research project at most?

"That is correct, the online clinicaltrials.gov registry shows that this research project is open for recruitment and has been since October 6th, 2021. The 349 patients will be spread out across 16 hospitals or clinics."

Answered by AI

For what medical reasons is Secukinumab 300 mg usually prescribed?

"The secukinumab 300 mg dosage is a standard intervention for ankylosing spondylitis, but can also help patients suffering from psoriatic arthritis, enthesitis related arthritis (era), and severe plaque psoriasis."

Answered by AI

Does Secukinumab 300 mg have any harmful side effects for people?

"Previous clinical trials have yielded some data supporting secukinumab's efficacy and multiple rounds of testing have shown that it is a safe medication. Therefore, our team has given it a score of 3."

Answered by AI

Is Secukinumab 300 mg a new medication?

"28 clinical trials for Secukinumab 300 mg are currently underway with 13 of them in Phase 3. The study locations for Secukinumab 300 mg include Brest and Buenos Aires among other cities."

Answered by AI
~81 spots leftby Jan 2025