CompletedPhase 1

Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Intravenous Secukinumab in Patients With GCA or PMR

United States, Czechia, Italy65 participantsStarted 2024-03-27

Plain-language summary

This study will examine how intravenous (i.v.) Secukinumab will be processed in the body (pharmacokinetics \[PK\]) and whether it will be safe and tolerable after multiple doses of i.v. Secukinumab infusion in adult patients with giant cell arteritis (GCA) or polymyalgia rheumatica (PMR).

Who can participate

Age range

50 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or non-pregnant, non-lactating female participants at least 50 years of age
. Diagnosis of GCA based on meeting all of the following criteria:
. Active GCA disease within 6 months prior to Baseline as defined by meeting both of the following:
. Male or non-pregnant, non-lactating female participants at least 50 years of age
. Diagnosis of PMR according to the provisional ACR/EULAR classification criteria: Participants \>= 50 years of age with a history of bilateral shoulder pain accompanied by elevated CRP concentration (\>= 10 mg/L) and/or elevated ESR (\>= 30 mm/hr) who scored at least 4 points from the following optional classification criteria:
. Active PMR disease within 6 months prior to Baseline as defined by signs and symptoms attributable to PMR meeting the following:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Secukinumab: Maximum concentration at steady state (Cmax,ss)

Timeframe: Baseline, Week 4 and Week 8: Pre-dose and End-of Infusion (EOI); Weeks 9, 10, 11, 12, 16 and 20: Anytime

Secukinumab: Minimum concentration at steady state (Cmin,ss)

Timeframe: Baseline, Week 4 and Week 8: Pre-dose and End-of Infusion (EOI); Weeks 9, 10, 11, 12, 16 and 20: Anytime

Secukinumab: Area under the concentration-time curve at steady state during a dosing interval (AUCtau,ss)

Timeframe: Baseline, Week 4 and Week 8: Pre-dose and End-of Infusion (EOI); Weeks 9, 10, 11, 12, 16 and 20: Anytime

Secukinumab: Average concentration at steady state (Cavg,ss [=AUCtau,ss/tau])

Timeframe: Baseline, Week 4 and Week 8: Pre-dose and End-of Infusion (EOI); Weeks 9, 10, 11, 12, 16 and 20: Anytime

Trial details

NCT IDNCT06130540

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-12

View on ClinicalTrials.gov More Giant Cell Arteritis trials

Who can participate

Age range

50 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or non-pregnant, non-lactating female participants at least 50 years of age
. Diagnosis of GCA based on meeting all of the following criteria:
. Active GCA disease within 6 months prior to Baseline as defined by meeting both of the following:
. Male or non-pregnant, non-lactating female participants at least 50 years of age
. Diagnosis of PMR according to the provisional ACR/EULAR classification criteria: Participants \>= 50 years of age with a history of bilateral shoulder pain accompanied by elevated CRP concentration (\>= 10 mg/L) and/or elevated ESR (\>= 30 mm/hr) who scored at least 4 points from the following optional classification criteria:
. Active PMR disease within 6 months prior to Baseline as defined by signs and symptoms attributable to PMR meeting the following: