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NCT05767034

PHASE3

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Evaluate Efficacy and Safety of Secukinumab Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)

Key Details

Gender

All

Age Range

50 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

381

Start Date

2023-03-22

Completion Date

2026-02-16

Last Updated

2026-06-22

Healthy Volunteers

Conditions

Polymyalgia Rheumatica

Interventions

DRUG

Secukinumab 300 mg

Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen

DRUG

Secukinumab 150 mg

Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen

OTHER

Placebo to secukinumab

Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (132)

Arizona Arthritis and Rheumatology Associates PLLC

Avondale, Arizona, United States

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

Novartis Investigative Site

Parramatta, New South Wales, Australia

Novartis Investigative Site

Southport, Queensland, Australia

Novartis Investigative Site

Heidelberg Heights, Victoria, Australia

Novartis Investigative Site

Leuven, Belgium

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

Santiago, Santiago Metropolitan, Chile

Novartis Investigative Site

Viña del Mar, Valparaiso, Chile

Novartis Investigative Site

Barranquilla, Atlántico, Colombia

Novartis Investigative Site

Barranquilla, Atlántico, Colombia

Novartis Investigative Site

Bogota, Cundinamarca, Colombia

Novartis Investigative Site

Cali, Valle del Cauca Department, Colombia

Novartis Investigative Site

Prague, Czech Republic, Czechia

Novartis Investigative Site

Brno, Czechia

Novartis Investigative Site

Hlučín, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Uherské Hradiště, Czechia

Novartis Investigative Site

Zlín, Czechia

Novartis Investigative Site

Aarhus N, Denmark

Novartis Investigative Site

Esbjerg, Denmark

Novartis Investigative Site

Gandrup, Denmark

Novartis Investigative Site

Vejle, Denmark

Novartis Investigative Site

Limoges, Haute Vienne, France

Novartis Investigative Site

Toulon, Val De Marne, France

Novartis Investigative Site

Aix-en-Provence, France

Novartis Investigative Site

Brest, France

Novartis Investigative Site

Cholet, France

Novartis Investigative Site

Colmar, France

Novartis Investigative Site

Dijon, France

Novartis Investigative Site

Le Mans, France

Novartis Investigative Site

Montpellier, France

Novartis Investigative Site

Nantes, France

Novartis Investigative Site

Reims, France

Novartis Investigative Site

Strasbourg, France

Novartis Investigative Site

Toulouse, France

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Novartis Investigative Site

Würzburg, Bavaria, Germany

Novartis Investigative Site

Dresden, Saxony, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Erlangen, Germany

Novartis Investigative Site

Herne, Germany

Novartis Investigative Site

Ratingen, Germany

Novartis Investigative Site

Rendsburg, Germany

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Szeged, Hungary

Novartis Investigative Site

Veszprém, Hungary

Novartis Investigative Site

Dublin, Ireland

Novartis Investigative Site

Ramat Gan, Israel

Novartis Investigative Site

Tel Aviv, Israel

Novartis Investigative Site

Bolzano, BZ, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Perugia, PG, Italy

Novartis Investigative Site

Pavia, PV, Italy

Novartis Investigative Site

Reggio Emilia, RE, Italy

Novartis Investigative Site

Ichikawa, Chiba, Japan

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Novartis Investigative Site

Asahikawa, Hokkaido, Japan

Novartis Investigative Site

Kita-gun, Kagawa-ken, Japan

Novartis Investigative Site

Sagamihara, Kanagawa, Japan

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Novartis Investigative Site

Nagano, Nagano, Japan

Novartis Investigative Site

Beppu, Oita Prefecture, Japan

Novartis Investigative Site

Kawachi-Nagano, Osaka, Japan

Novartis Investigative Site

Osaka, Osaka, Japan

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Novartis Investigative Site

Fuchū, Tokyo, Japan

And 32 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (132)