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

Part of paid clinical trials in Boca Raton, Florida.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06130540
Phase
PHASE1
Status
Completed

Conditions

  • Giant Cell Arteritis
  • Polymyalgia Rheumatica

Eligibility Criteria

Sex
ALL
Age
50 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab — DRUG
    Intravenous (i.v.) doses of Secukinumab at Week 0, Week 4 and Week 8

Study Details

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).

Key Dates

Start date
Mar 27, 2024
Status verified
Mar 2026
Primary completion
Mar 12, 2025
Completion
Apr 2, 2025

Study Design

Enrollment
65 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Secukinumab: Giant Cell Arteritis (GCA)
  • Experimental: Secukinumab: Polymyalgia Rheumatica (PMR)

Primary Outcome Measure

Secukinumab: Maximum concentration at steady state (Cmax,ss) [ Time Frame: Baseline, Week 4 and Week 8: Pre-dose and End-of Infusion (EOI); Weeks 9, 10, 11, 12, 16 and 20: Anytime ]

Locations (8)

FacilityCityStateZIPSite coordinators
Rheumatology Associates of South FloridaBoca RatonFlorida33486-
FL Medical Clinic Orlando HealthZephyrhillsFlorida33542-
Willow Rheumatology WellnessWillowbrookIllinois60527-
Altoona Center for Clin ResDuncansvillePennsylvania16635-
West Tennessee Research InstituteJacksonTennessee38305-
Accurate Clinical Research IncSan AntonioTexas78229-
Overlake Internal Med AssociatesBellevueWashington98004-
Rheumatology Pulmonary ClinicBeckleyWest Virginia25801-

Find similar trials in Boca Raton, FL

By research site
Rheumatology Associates of South Florida· Boca Raton, FLFL Medical Clinic Orlando Health· Zephyrhills, FLWillow Rheumatology Wellness· Willowbrook, ILAltoona Center for Clin Res· Duncansville, PAWest Tennessee Research Institute· Jackson, TNAccurate Clinical Research Inc· San Antonio, TX

Related Studies