Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)

Running, not enrolling · Phase 3

Conditions studied: Polymyalgia Rheumatica

In brief

The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica.

Key facts

Study ID

NCT06331312

Run by

Novartis Pharmaceuticals

People needed

162

Starts

2024-06-28

Expected to finish

2028-05-08

Last updated by the study team

2026-07-24

Who can join

Age: 50 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who have completed 52-week Treatment Period as per protocol in a Novartis study of secukinumab in PMR patients (the "core study" - Study CAIN457C22301), AND
• who have experienced a relapse during the treatment-free follow-up period of the core study, AND
• who have not been on rescue treatment.
• The participant would potentially derive benefit from secukinumab, and the benefit outweighs the risk, based on the investigator's judgement.

You may not qualify if…

• Use of prohibited medications, as specified in the protocol
• History of ongoing, chronic or recurrent infectious disease (i.e., human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV), active tuberculosis infection (TB))
• History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
• Live vaccinations (e.g., monkey pox vaccine, oral polio vaccine, varicella/zoster vaccines) within 6 weeks prior to Baseline
• Subjects whose participation in the extension study could expose them to an undue safety risk

Where it is running

• Sun Valley Arthritis Center Ltd — Peoria, Arizona, United States
• Center for Rheumatology Research — West Hills, California, United States
• Millennium Clinical Trials — Westlake Village, California, United States
• Rheumatology Associates of South Florida — Boca Raton, Florida, United States
• West Broward Rheumatology Associates Inc — Tamarac, Florida, United States
• Klein and Associates — Hagerstown, Maryland, United States
• Clinical Research Inst of MI — Saint Clair Shores, Michigan, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Paramount Med Rsrch and Consult LLC — Middleburg Heights, Ohio, United States
• Prolato Clinical Research Center — Houston, Texas, United States
• Accurate Clinical Research Inc — Houston, Texas, United States
• Advanced Rheumatology of Houston — The Woodlands, Texas, United States
• Novartis Investigative Site — Quilmes, Buenos Aires, Argentina
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Parramatta, New South Wales, Australia
• Novartis Investigative Site — Heidelberg Heights, Victoria, Australia
• Novartis Investigative Site — Liège, Belgium
• Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, Brazil
• Novartis Investigative Site — Québec, Quebec, Canada
• Novartis Investigative Site — Santiago, Santiago Metropolitan, Chile
• Novartis Investigative Site — Santiago, Santiago Metropolitan, Chile
• Novartis Investigative Site — Viña del Mar, Valparaiso, Chile
• Arizona Arthritis and Rheumatology Associates PLLC — Avondale, Arizona, United States

Full record on ClinicalTrials.gov

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