NCT06130540

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

An Open-label, Multicenter Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Intravenous Secukinumab Infusion in Adults With Giant Cell Arteritis (GCA) or Polymyalgia Rheumatica (PMR)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a 12-week, open-label, multicenter, basket design study followed by an 8-week follow-up period in two cohorts of participants, one cohort with GCA and one cohort with PMR. This study will consist of 3 phases: screening, treatment and follow-up. Participants will enter a screening period: up to 6 weeks to assess eligibility \[or up to 8 weeks in the event of a major healthcare disruption or a need to complete screening requirements (e.g., required washouts, TB testing, and work up and treatment as needed per local guidelines. Participants will enter a treatment period of 12 weeks: 2 cohorts (GCA and PMR cohorts) receiving total of 3 i.v. doses of Secukinumab (Week 0, Week 4 and Week 8). After treatment participants will enter a follow-up period: 8 weeks treatment-free follow-up (12 weeks after last dose of study treatment). The total duration of the trial for a participant (from screening to follow up) is approximately 26 weeks (maximum of approximately 28 weeks) including safety follow-up.

Conditions

• Giant Cell Arteritis
• Polymyalgia Rheumatica

Interventions

Type	Name	Description
DRUG	Secukinumab	Intravenous (i.v.) doses of Secukinumab at Week 0, Week 4 and Week 8

Timeline

• Start date: 2024-03-27
• Primary completion: 2025-03-12
• Completion: 2025-04-02
• First posted: 2023-11-14
• Last updated: 2026-04-01

Locations

19 sites across 6 countries: United States, Czechia, Italy, Portugal, Spain, Switzerland

Regulatory

• FDA-regulated drug study