Open-Label, Multicenter Study To Evaluate Iv Secukinumab (Cosentyx) Infusion In Adults With Giant Cell Arteritis (Gca) Or Polymyalgia Rheumatica (Pma)
Posted Date: Jul 10, 2024
- Investigator: David Greenblatt
- Specialties: Immunology, Rheumatology
- Type of Study: Drug
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). The primary outcome measure for this study is the PK after multiple doses of i.v. secukinumab infusion. Secukinumab has demonstrated a positive benefit/risk profile in the treatment of multiple chronic inflammatory diseases, including psoriasis (PsO), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), and there is a potential to also confirm a favorable benefit-risk profile of secukinumab in GCA and PMR participants with the Phase III trials assessing the efficacy and safety of subcutaneous (s.c.) administration of secukinumab which are currently ongoing. The patient population with GCA and PMR is older than the patient population with PsA, AS and nr-axSpA, and an unmet medical need exists for a subset of this elderly population for whom the i.v. infusion will be preferable, as some patients may either have difficulty administering the s.c. injections and/or may have suboptimal adherence to s.c. treatment. To date, limited PK data for secukinumab has been collected in GCA and PMR patients. The study consists of 1.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) 2.A treatment period of 12 weeks: 2 cohorts (GCA and PMR cohorts) receiving total of 3 i.v. doses of secukinumab (4 mg/kg i.v. as the loading dose at Week 0 and 2 mg/kg i.v. at Weeks 4 and 8) 3.A follow-up period: up to 8 weeks treatment-free follow-up (up to 12 weeks after last dose of study treatment) Post trial access (PTA) of secukinumab, where available, will be offered to participants who completed the 12-week treatment period and who, in the opinion of the Investigator have benefited from continued treatment of secukinumab, and when in accordance with local laws and regulations
Criteria:
At Least 50 Years Of Age Diagnosed With Gca Or Pmr With Active Disease Within 6 Months. Participants Must Not Have Had Any Hypersensitivity Or Contraindication To Similar Drugs, Any Clinically Significant Liver Disease, Use Of Other Investigational Drugs Within 30 Days, Active Infections Or History Of Ongoing, Chronic Or Recurrent Infections, Active Inflammatory Bowel Disease, Current Severe Progressive Or Uncontrolled Disease, Tia Or Stroke Within 12 Weeks.
Keywords:
Giant Cell Arteritis (Gca), Polymyalgia Rheumatica (Pmr), Monoclonal Antibody
For More Information:
Peggy A. Mccaffery
5135583510
mccaffpy@ucmail.uc.edu