Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)

Completed · Phase 3 · Has a placebo group

Conditions studied: Polymyalgia Rheumatica

In brief

The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.

Key facts

Study ID

NCT05767034

Run by

Novartis Pharmaceuticals

People needed

381

Starts

2023-03-22

Expected to finish

2026-02-16

Last updated by the study team

2026-06-22

Who can join

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

You may qualify if…

• Signed informed consent must be obtained prior to participation in the study
• Male or non-pregnant, non-lactating female participants at least 50 years of age.
• Diagnosis of PMR according to the provisional American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria: Participants ≥ 50 years of age with a history of bilateral shoulder pain accompanied by elevated C-reactive protein (CRP) concentration (≥ 10 mg/L) and/or elevated erythrocyte sedimentation rate (ESR) (≥ 30 mm/hr) who scored at least 4 points from the following optional classification criteria:
• Morning stiffness > 45 minutes (min) (2 points)
• Hip pain or restricted range of motion (1 point)
• Absence of rheumatoid factor and/or anti-citrullinated protein antibodies (2 points)
• Absence of other joint involvement (1 point)
• Participants must have a history of being treated for at least 8 consecutive weeks with prednisone ≥ 10 mg/day, or equivalent dose of another GC at any time prior to screening
• Participants must have had at least one episode of PMR relapse while attempting to taper prednisone at a dose that is ≥ 5 mg/day (or equivalent dose of another GC) within the past 12 weeks prior to BSL. Diagnosis of a PMR relapse is defined as participant meeting both of the following:
• Recurrence of bilateral shoulder girdle and/or bilateral hip girdle pain associated with inflammatory stiffness with or without additional symptoms indicative of PMR relapse (such as constitutional symptoms) within 12 weeks prior to BSL that are in the opinion of the Investigator not due to other diseases that may mimic PMR such as osteoarthritis in shoulders or hips, polyarticular calcium pyrophosphate deposition disease, rotator cuff disease, adhesive capsulitis (frozen shoulder) or fibromyalgia.
• Elevated ESR (≥ 30 mm/hr) and/or elevated CRP (> upper limit of normal (ULN)) attributable to PMR at the time of relapse and/or at screening
• Participants must have been treated as per local treatment recommendations following the latest PMR relapse and must be on prednisone of at least 7.5 mg/day (or equivalent) and not exceeding 25 mg/day at screening and during the screening period

You may not qualify if…

• Evidence/history of GCA as indicated by typical (cranial) symptoms (e.g., persistent or recurrent localized headache, temporal artery or scalp tenderness, jaw claudication, blurry or loss of vision, symptoms of stroke), extremity claudication, imaging and/or temporal artery biopsy result
• Concurrent rheumatoid arthritis or other inflammatory arthritis or other connective tissue diseases, such as but not limited to systemic lupus erythematosus, systemic sclerosis, vasculitis, myositis, mixed connective tissue disease, and ankylosing spondylitis
• Concurrent diagnosis or history of neuropathic muscular diseases or fibromyalgia
• Inadequately treated hypothyroidism (e.g., persistence of symptoms, lack of normalization of serum TSH despite regular hormonal replacement treatment)
• Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor
• Participants treated with tocilizumab or other IL-6/IL6-receptor inhibitors within 12 weeks or within 5 half-lives (whichever is longer) prior to BSL; participant who did not respond to or experienced a relapse during treatment are excluded from enrollment into the study Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Sun Valley Arthritis Center Ltd — Peoria, Arizona, United States
• AZ Arthritis and Rheumtlgy Rsh PLLC — Phoenix, Arizona, United States
• Precn Comprehensive Clnl Rsch Solns — San Leandro, California, United States
• Providence Saint Johns Health Ctr — Santa Monica, California, 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
• UF Health Cancer Center — Gainesville, Florida, United States
• Sarasota Arthritis Res Ctr — Sarasota, Florida, United States
• West Broward Rheumatology Associates Inc — Tamarac, Florida, United States
• Southeastern Rheumatology Alliance — Gainesville, Georgia, United States
• Klein and Associates — Hagerstown, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Clinical Research Inst of MI — Saint Clair Shores, Michigan, United States
• Kansas City Physician Partners — Kansas City, Missouri, 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
• DM Clinical Research — Houston, Texas, United States
• Accurate Clinical Research Inc — Houston, Texas, United States
• Advanced Rheumatology of Houston — Spring, Texas, United States
• Novartis Investigative Site — Caba, Buenos Aires, Argentina
• Novartis Investigative Site — Quilmes, Buenos Aires, Argentina
• Novartis Investigative Site — Buenos Aires, Argentina
• Arizona Arthritis and Rheumatology Associates PLLC — Avondale, Arizona, United States

Full record on ClinicalTrials.gov

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