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

NCT06331312 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: CAIN457C22301E12023-508077-85-00
• Study Type: interventional
• Target: 161
• Locations: 22 countries
• Sites: 99

Brief Summary

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

Conditions

Polymyalgia Rheumatica

Keywords

Polymyalgia Rheumatica (PMR); secukinumab; monoclonal antibody; subcutaneous (s.c.); extension; long-term; safety; REPLENISH

Outcome Measures

Primary Outcomes (1)

• Incidences of treatment emergent adverse events (AEs) and serious adverse events (SAEs)

  The number and percentage of participants with treatment emergent AEs/SAEs will be summarized. No hypothesis testing will be performed.

  After the first dose of study treatment and within 84 days after the last dose

Study Arms (1)

Secukinumab 300mg

EXPERIMENTAL

All eligible participants will receive secukinumab 300 mg s.c. (2 x 150mg/1mL PFS secukinumab) from baseline and every 4 weeks up to 2 years. The study medication may be modified/adjusted after the initial doses of 300mg s.c. (decreased to 150mg s.c. q4w or increased again from 150mg s.c. q4w to 300mg s.c. q4w) if deemed appropriate by the investigator. Dose modification/adjustment may only occur from Week 24 visit onwards. The modification/adjustment of the study medication will be determined at a site visit.

Biological: Secukinumab

Interventions

Secukinumab BIOLOGICAL

2 x 150mg/1mL PFS secukinumab

Secukinumab 300mg

Eligibility Criteria

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

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (99)

Arizona Arthritis and Rheumatology Associates PLLC

Avondale, Arizona, 85392, United States

Location

Sun Valley Arthritis Center Ltd

Peoria, Arizona, 85381, United States

Location

Orrin Troum MD and Medical Associates

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

Location

Sarasota Arthritis Res Ctr

Sarasota, Florida, 34239, United States

Location

West Broward Rheumatology Associates Inc

Tamarac, Florida, 33321, United States

Location

Arthritis Center of North Georgia

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

Location

Paramount Med Rsrch and Consult LLC

Middleburg Heights, Ohio, 44130, United States

Location

Prolato Clinical Research Center

Houston, Texas, 77054, United States

Location

Accurate Clinical Research Inc

San Antonio, Texas, 78229, United States

Location

Advanced Rheumatology of Houston

Spring, Texas, 77382, United States

Location

Novartis Investigative Site

Quilmes, Buenos Aires, B1878GEG, Argentina

Location

Novartis Investigative Site

Buenos Aires, C1055AAF, Argentina

Location

Novartis Investigative Site

Parramatta, New South Wales, 2150, Australia

Location

Novartis Investigative Site

Southport, Queensland, 4215, Australia

Location

Novartis Investigative Site

Heidelberg Heights, Victoria, 3081, Australia

Location

Novartis Investigative Site

Liège, 4000, Belgium

Location

Novartis Investigative Site

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

Location

Novartis Investigative Site

São Paulo, São Paulo, 04038-002, Brazil

Location

Novartis Investigative Site

São Paulo, 01409-902, Brazil

Location

Novartis Investigative Site

Québec, Quebec, G1V 3M7, Canada

Location

Novartis Investigative Site

Santiago, Santiago Metropolitan, 7500571, Chile

Location

Novartis Investigative Site

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Novartis Investigative Site

Viña del Mar, Valparaiso, 2531172, Chile

Location

Novartis Investigative Site

Barranquilla, Atlántico, 080002, Colombia

Location

Novartis Investigative Site

Barranquilla, Atlántico, 080020, Colombia

Location

Novartis Investigative Site

Bogota, Cundinamarca, 110221, Colombia

Location

Novartis Investigative Site

Cali, Valle del Cauca Department, 760042, Colombia

Location

Novartis Investigative Site

Prague, Czech Republic, 140 00, Czechia

Location

Novartis Investigative Site

Brno, 638 00, Czechia

Location

Novartis Investigative Site

Hlučín, 748 01, Czechia

Location

Novartis Investigative Site

Prague, 128 00, Czechia

Location

Novartis Investigative Site

Prague, 140 00, Czechia

Location

Novartis Investigative Site

Uherské Hradiště, 686 01, Czechia

Location

Novartis Investigative Site

Zlín, 760 01, Czechia

Location

Novartis Investigative Site

Esbjerg, 6700, Denmark

Location

Novartis Investigative Site

Gandrup, 9362, Denmark

Location

Novartis Investigative Site

Vejle, DK-7100, Denmark

Location

Novartis Investigative Site

Toulon, Val De Marne, 83800, France

Location

Novartis Investigative Site

Brest, 29200, France

Location

Novartis Investigative Site

Cholet, 49325, France

Location

Novartis Investigative Site

Colmar, 68024, France

Location

Novartis Investigative Site

Dijon, 21000, France

Location

Novartis Investigative Site

Le Mans, 72000, France

Location

Novartis Investigative Site

Montpellier, 34295, France

Location

Novartis Investigative Site

Nantes, 44093, France

Location

Novartis Investigative Site

Reims, 51092, France

Location

Novartis Investigative Site

Strasbourg, 67000, France

Location

Novartis Investigative Site

Toulouse, 31059, France

Location

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Novartis Investigative Site

Würzburg, Bavaria, 97080, Germany

Location

Novartis Investigative Site

Berlin, 13125, Germany

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Herne, 44649, Germany

Location

Novartis Investigative Site

Budapest, 1027, Hungary

Location

Novartis Investigative Site

Szeged, 6725, Hungary

Location

Novartis Investigative Site

Veszprém, 8200, Hungary

Location

Novartis Investigative Site

Bolzano, BZ, 39100, Italy

Location

Novartis Investigative Site

Milan, MI, 20100, Italy

Location

Novartis Investigative Site

Perugia, PG, 06129, Italy

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 8140180, Japan

Location

Novartis Investigative Site

Asahikawa, Hokkaido, 0708644, Japan

Location

Novartis Investigative Site

Kita-gun, Kagawa-ken, 7610793, Japan

Location

Novartis Investigative Site

Sagamihara, Kanagawa, 252-0392, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 222-0036, Japan

Location

Novartis Investigative Site

Nagano, Nagano, 3808582, Japan

Location

Novartis Investigative Site

Kawachi-Nagano, Osaka, 5868521, Japan

Location

Novartis Investigative Site

Bunkyo Ku, Tokyo, 1138431, Japan

Location

Novartis Investigative Site

Fuchū, Tokyo, 1838524, Japan

Location

Novartis Investigative Site

Ōme, Tokyo, 198-0042, Japan

Location

Novartis Investigative Site

Chūō, Yamanashi, 409-3898, Japan

Location

Novartis Investigative Site

Okayama, 700-8607, Japan

Location

Novartis Investigative Site

Osaka, 5340021, Japan

Location

Novartis Investigative Site

Guadalajara, Jalisco, 44650, Mexico

Location

Novartis Investigative Site

Almelo, Overijssel, 7609 PP, Netherlands

Location

Novartis Investigative Site

Rotterdam, South Holland, 3079 DZ, Netherlands

Location

Novartis Investigative Site

Lublin, 20-607, Poland

Location

Novartis Investigative Site

Warsaw, 02-118, Poland

Location

Novartis Investigative Site

Warsaw, 02-665, Poland

Location

Novartis Investigative Site

Cape Town, Western Cape, 7405, South Africa

Location

Novartis Investigative Site

Cape Town, Western Cape, 7500, South Africa

Location

Novartis Investigative Site

Sabadell, Barcelona, 08208, Spain

Location

Novartis Investigative Site

Bilbao, Bizkaia, 48013, Spain

Location

Novartis Investigative Site

A Coruña, 15006, Spain

Location

Novartis Investigative Site

Madrid, 28009, Spain

Location

Novartis Investigative Site

Seville, 41013, Spain

Location

Novartis Investigative Site

Valencia, 46010, Spain

Location

Novartis Investigative Site

Sankt Gallen, 9007, Switzerland

Location

Novartis Investigative Site

Barnet, EN5 3DJ, United Kingdom

Location

Novartis Investigative Site

Hull, HU3 2RW, United Kingdom

Location

Novartis Investigative Site

Wolverhampton, WV10 0QP, United Kingdom

Location

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 26, 2024
• Study Start: June 28, 2024
• Primary Completion (Estimated): August 22, 2028
• Study Completion (Estimated): August 22, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

AR (2); DK (3); JP (13); ES (6); CH (1); CZ (7); CL (3); CA (1); GB (3); ZA (2); NL (2); ME (1); US (19); AU (3); FR (11); IT (3); BE (1); PL (3); BR (3); CO (4); DE (5); HU (3)