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

NCT05767034 | Completed Phase 3 FDA Drug

• 2 other identifiers: CAIN457C223012022-501895-25-00
• Study Type: interventional
• Target: 381
• Locations: 27 countries
• Sites: 133

Brief 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.

Conditions

Polymyalgia Rheumatica

Keywords

Polymyalgia Rheumatica; secukinumab; monoclonal antibody; prednisone taper regimen; glucocorticoid; PMR

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving sustained remission

  Sustained remission at Week 52 is defined as a participant meeting all of the following: ● achieved remission at Week 12 AND all of the following, sustained from Week 12 to Week 52: * no recurrence of signs or symptoms, attributable to PMR, that requires escape treatment or rescue treatment * no new diagnosis of Giant cell arteritis (GCA), that requires escape treatment or rescue treatment Remission at Week 12 is defined as a participant meeting all of the following at Week 12: * no use of escape treatment or rescue treatment prior to Week 12 * no signs or symptoms attributable to PMR, that requires escape treatment or use of rescue treatment, at Week 12 * no new diagnosis of GCA, that requires escape treatment or rescue treatment, at Week 12

  at Week 52

Secondary Outcomes (5)

• Proportion of patients achieving complete sustained remission

  52 Weeks

• Adjusted annual cumulative glucocorticoid (GC) dose adjusted by duration of study follow-up

  52 Weeks

• Time to first use of escape treatment or rescue treatment as measured in days

  52 Weeks

• Change in FACIT-Fatigue Score

  52 Weeks

• Change in HAQ-DI score

  52 Weeks

Study Arms (3)

Secukinumab 300 mg

EXPERIMENTAL

randomized in 1:1:1 ratio every 4 weeks

Drug: Secukinumab 300 mg

Secukinumab 150 mg

EXPERIMENTAL

randomized in 1:1:1 ratio every 4 weeks

Drug: Secukinumab 150 mg

Placebo to secukinumab

PLACEBO COMPARATOR

randomized in 1:1:1 ratio every 4 weeks

Other: Placebo to secukinumab

Interventions

Secukinumab 300 mg DRUG

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

Also known as: AIN457

Secukinumab 300 mg

Secukinumab 150 mg DRUG

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

Also known as: AIN457

Secukinumab 150 mg

Placebo to secukinumab OTHER

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

Placebo to secukinumab

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (133)

Arizona Arthritis and Rheumatology Associates PLLC

Avondale, Arizona, 85392, United States

Location

Sun Valley Arthritis Center Ltd

Peoria, Arizona, 85381, United States

Location

AZ Arthritis and Rheumtlgy Rsh PLLC

Phoenix, Arizona, 85032, United States

Location

Precn Comprehensive Clnl Rsch Solns

San Leandro, California, 94578, United States

Location

Providence Saint Johns Health Ctr

Santa Monica, California, 90404, United States

Location

Center for Rheumatology Research

West Hills, California, 91307, United States

Location

Millennium Clinical Trials

Westlake Village, California, 91361, United States

Location

Rheumatology Associates of South Florida

Boca Raton, Florida, 33486, United States

Location

UF Health Cancer Center

Gainesville, Florida, 32610, United States

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Sarasota Arthritis Res Ctr

Sarasota, Florida, 34239, United States

Location

West Broward Rheumatology Associates Inc

Tamarac, Florida, 33321, United States

Location

Southeastern Rheumatology Alliance

Gainesville, Georgia, 30501, United States

Location

Klein and Associates

Hagerstown, Maryland, 21740, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Clinical Research Inst of MI

Saint Clair Shores, Michigan, 48081, United States

Location

Kansas City Physician Partners

Kansas City, Missouri, 64111, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

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Paramount Med Rsrch and Consult LLC

Middleburg Heights, Ohio, 44130, United States

Location

Prolato Clinical Research Center

Houston, Texas, 77054, United States

Location

DM Clinical Research

Houston, Texas, 77070, United States

Location

Accurate Clinical Research Inc

San Antonio, Texas, 78229, United States

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Advanced Rheumatology of Houston

Spring, Texas, 77382, United States

Location

Novartis Investigative Site

Caba, Buenos Aires, C1119ACN, Argentina

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Novartis Investigative Site

Quilmes, Buenos Aires, B1878GEG, Argentina

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Novartis Investigative Site

Buenos Aires, C1055AAF, Argentina

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Novartis Investigative Site

Parramatta, New South Wales, 2150, Australia

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Novartis Investigative Site

Southport, Queensland, 4215, Australia

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Novartis Investigative Site

Heidelberg Heights, Victoria, 3081, Australia

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Novartis Investigative Site

Leuven, 3000, Belgium

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Novartis Investigative Site

Liège, 4000, Belgium

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Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

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Novartis Investigative Site

São Paulo, São Paulo, 04038-002, Brazil

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Novartis Investigative Site

São Paulo, 01409-902, Brazil

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Novartis Investigative Site

Québec, Quebec, G1V 3M7, Canada

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Novartis Investigative Site

Viña del Mar, Región de Valparaíso, 2531172, Chile

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Novartis Investigative Site

Santiago, Santiago Metropolitan, 7500571, Chile

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Novartis Investigative Site

Santiago, Santiago Metropolitan, 8380465, Chile

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Novartis Investigative Site

Santiago, Santiago Metropolitan, 8420383, Chile

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Barranquilla, Atlántico, 080002, Colombia

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Barranquilla, Atlántico, 080020, Colombia

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Bogota, Cundinamarca, 110221, Colombia

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Cali, Valle del Cauca Department, 760042, Colombia

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Prague, Czech Republic, 140 00, Czechia

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Brno, 638 00, Czechia

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Novartis Investigative Site

Hlučín, 748 01, Czechia

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Novartis Investigative Site

Prague, 128 00, Czechia

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Novartis Investigative Site

Prague, 140 00, Czechia

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Novartis Investigative Site

Uherské Hradiště, 686 01, Czechia

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Novartis Investigative Site

Zlín, 760 01, Czechia

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Aarhus N, 8200, Denmark

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Esbjerg, 6700, Denmark

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Gandrup, 9362, Denmark

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Vejle, DK-7100, Denmark

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Limoges, Haute Vienne, 87000, France

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Toulon, Val De Marne, 83800, France

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Aix-en-Provence, 13616, France

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Brest, 29200, France

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Cholet, 49325, France

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Colmar, 68024, France

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Dijon, 21000, France

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Le Mans, 72000, France

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Montpellier, 34295, France

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Nantes, 44093, France

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Reims, 51092, France

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Strasbourg, 67000, France

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Toulouse, 31059, France

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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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Würzburg, Bavaria, 97080, Germany

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Dresden, Saxony, 01307, Germany

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Berlin, 13125, Germany

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Berlin, 13353, Germany

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Erlangen, 91056, Germany

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Herne, 44649, Germany

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Ratingen, 40878, Germany

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Rendsburg, 24768, Germany

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Budapest, 1027, Hungary

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Szeged, 6725, Hungary

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Veszprém, 8200, Hungary

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Reykjavik, 101, Iceland

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Dublin, D03 VX82, Ireland

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Ramat Gan, 5265601, Israel

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Tel Aviv, 6423906, Israel

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Bolzano, BZ, 39100, Italy

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Milan, MI, 20100, Italy

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Milan, MI, 20132, Italy

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Milan, MI, 20157, Italy

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Perugia, PG, 06129, Italy

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Pavia, PV, 27100, Italy

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Reggio Emilia, RE, 42123, Italy

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Ichikawa, Chiba, 2728516, Japan

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Fukuoka, Fukuoka, 8140180, Japan

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Asahikawa, Hokkaido, 0708644, Japan

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Kita-gun, Kagawa-ken, 7610793, Japan

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Sagamihara, Kanagawa, 252-0392, Japan

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Yokohama, Kanagawa, 222-0036, Japan

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Nagano, Nagano, 3808582, Japan

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Beppu, Oita Prefecture, 8740011, Japan

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Kawachi-Nagano, Osaka, 5868521, Japan

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Osaka, Osaka, 550-0006, Japan

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Bunkyo Ku, Tokyo, 1138431, Japan

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Novartis Investigative Site

Fuchū, Tokyo, 1838524, Japan

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Ōme, Tokyo, 198-0042, Japan

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Shimonoseki, Yamaguchi, 750-0041, Japan

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Novartis Investigative Site

Chūō, Yamanashi, 409-3898, Japan

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Novartis Investigative Site

Okayama, 700-8607, Japan

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Osaka, 5340021, Japan

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Beirut, 166830, Lebanon

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Guadalajara, Jalisco, 44650, Mexico

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Almelo, Overijssel, 7609 PP, Netherlands

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Rotterdam, South Holland, 3079 DZ, Netherlands

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Novartis Investigative Site

Groningen, 9713 GZ, Netherlands

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Novartis Investigative Site

Bytom, 41 902, Poland

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Lublin, 20-607, Poland

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Warsaw, 02-118, Poland

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Warsaw, 02-637, Poland

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Warsaw, 02-665, Poland

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Cape Town, Western Cape, 7405, South Africa

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Cape Town, Western Cape, 7500, South Africa

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Stellenbosch, Western Cape, 7600, South Africa

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Sabadell, Barcelona, 08208, Spain

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Novartis Investigative Site

Bilbao, Bizkaia, 48013, Spain

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Novartis Investigative Site

A Coruña, 15006, Spain

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Novartis Investigative Site

Barcelona, 08041, Spain

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Madrid, 28009, Spain

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Seville, 41013, Spain

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Valencia, 46010, Spain

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Stockholm, SE, 113 65, Sweden

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Basel, 4031, Switzerland

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Novartis Investigative Site

Fribourg, 1708, Switzerland

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Sankt Gallen, 9007, Switzerland

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Novartis Investigative Site

Barnet, EN5 3DJ, United Kingdom

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Novartis Investigative Site

Hull, HU3 2RW, United Kingdom

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Novartis Investigative Site

Wolverhampton, WV10 0QP, United Kingdom

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Related Publications (1)

• Sun MM, Pope JE. Polymyalgia rheumatica and giant cell arteritis: diagnosis and management. Curr Opin Rheumatol. 2025 Jan 1;37(1):32-38. doi: 10.1097/BOR.0000000000001059. Epub 2024 Oct 14.

  PMID: 39400109 DERIVED

MeSH Terms

Conditions

Polymyalgia Rheumatica

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 14, 2023
• Study Start: March 22, 2023
• Primary Completion: September 10, 2025
• Study Completion: February 16, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

ME (1); PL (5); CZ (7); AU (3); GB (3); BE (2); ES (7); CO (4); HU (3); CL (4); IL (2); ZA (3); SE (1); JP (17); DK (4); LE (1); DE (9); CA (1); US (22); IT (7); IE (1); NL (3); CH (3); AR (3); BR (3); IC (1); FR (13)