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

Last updated: June 4, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

3

Condition

Collagen Vascular Diseases

Connective Tissue Diseases

Polymyalgia Rheumatica (Pmr)

Treatment

Secukinumab

Clinical Study ID

NCT06331312
CAIN457C22301E1
2023-508077-85-00
  • Ages 50-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants who have completed 52-week Treatment Period as per protocol in aNovartis study of secukinumab in PMR patients (the "core study" - StudyCAIN457C22301), AND

  • who have experienced a relapse during the treatment-free follow-up period ofthe core study, AND

  • who have not been on rescue treatment.

  • The participant would potentially derive benefit from secukinumab, and the benefitoutweighs the risk, based on the investigator's judgement.

Exclusion

Exclusion Criteria:

  • Use of prohibited medications, as specified in the protocol

  • History of ongoing, chronic or recurrent infectious disease (i.e., humanimmunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV), activetuberculosis infection (TB))

  • History of lymphoproliferative disease or any known malignancy or history ofmalignancy of any organ system within the past 5 years (except for basal cellcarcinoma or actinic keratosis that have been treated with no evidence of recurrencein the past 3 months carcinoma in situ of the cervix or non-invasive malignant colonpolyps that have been removed).

  • Live vaccinations (e.g., monkey pox vaccine, oral polio vaccine, varicella/zostervaccines) within 6 weeks prior to Baseline

  • Subjects whose participation in the extension study could expose them to an unduesafety risk

Study Design

Total Participants: 161
Treatment Group(s): 1
Primary Treatment: Secukinumab
Phase: 3
Study Start date:
June 28, 2024
Estimated Completion Date:
May 08, 2028

Study Description

The study will consist of an up to 4-week screening period, an up to 2-year Treatment Period which includes two Treatment Periods, and a 16-week treatment-free follow-up period (20 weeks post last dose of secukinumab).

Treatment period:

There will be two Treatment Periods (TPs): TP1 will be from the first dose administration of secukinumab (Baseline) to Week 24, where visits will occur every 4 weeks, and TP2 will be from post Week 24 visit (post-dose) to up to 2 years. Participants will return to the study site every 4 weeks from Baseline until Week 24 (Weeks 16 and 20 visits are optional on-site visits and needed when participants are unwilling/uncomfortable to self-administer study treatment at home/offsite), then every 12 weeks afterwards in TP2 for resupply of study medication but may return earlier if needed (i.e., those participants who are unwilling/uncomfortable to self-administer study treatment can continue to visit site every 4 weeks for drug administration if they wish to do so).

Follow-up period: An EoS visit (20 weeks after last administration of secukinumab) will be done for all participants, regardless of whether they complete the entire study as planned, or they discontinue prematurely.

Connect with a study center

  • Novartis Investigative Site

    Quilmes, Buenos Aires B1878GEG
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Buenos Aires, C1055AAF
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Parramatta, New South Wales 2150
    Australia

    Site Not Available

  • Novartis Investigative Site

    Heidelberg Heights, Victoria 3081
    Australia

    Site Not Available

  • Novartis Investigative Site

    Liège, 4000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul 90480-000
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Sao Paulo, SP 04038-002
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    São Paulo 3448439, São Paulo 3448433 04038-002
    Brazil

    Site Not Available

  • Novartis Investigative Site

    São Paulo, 01409-902
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Québec, Quebec G1V 3M7
    Canada

    Site Not Available

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan 7500571
    Chile

    Site Not Available

  • Novartis Investigative Site

    Santiago 3871336, Santiago Metropolitan 3873544 8420383
    Chile

    Site Not Available

  • Novartis Investigative Site

    Viña del Mar, Valparaiso 2531172
    Chile

    Site Not Available

  • Novartis Investigative Site

    Barranquilla, Atlántico 080002
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Barranquilla 3689147, Atlántico 3689436 080002
    Colombia

    Active - Recruiting

  • Novartis Investigative Site

    Bogota, Cundinamarca 110221
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Praha 4, Czech Republic 140 00
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Brno, 638 00
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Hlučín, 748 01
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Prague, 128 00
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Prague 3067696, 140 00
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Uherské Hradiště, 686 01
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Esbjerg, 6700
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Gandrup, 9362
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Vejle, DK-7100
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Toulon, Val De Marne 83800
    France

    Site Not Available

  • Novartis Investigative Site

    Brest, 29200
    France

    Site Not Available

  • Novartis Investigative Site

    Colmar, 68024
    France

    Site Not Available

  • Novartis Investigative Site

    Dijon, 21000
    France

    Site Not Available

  • Novartis Investigative Site

    Dijon 3021372, 21034
    France

    Active - Recruiting

  • Novartis Investigative Site

    Reims, 51092
    France

    Site Not Available

  • Novartis Investigative Site

    Strasbourg, 67000
    France

    Site Not Available

  • Novartis Investigative Site

    Toulouse, 31059
    France

    Site Not Available

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg 79106
    Germany

    Site Not Available

  • Novartis Investigative Site

    Würzburg, Bavaria 97080
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 13353
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin 2950159, 13125
    Germany

    Site Not Available

  • Novartis Investigative Site

    Herne, 44649
    Germany

    Site Not Available

  • Novartis Investigative Site

    Budapest, 1027
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Szeged, 6725
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Veszprém, 8200
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Bolzano, BZ 39100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Milan, MI 20100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Milan 6951411, MI 20100
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Milano, MI 20132
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Perugia, PG 06129
    Italy

    Site Not Available

  • Novartis Investigative Site

    Fukuoka, Fukuoka 8140180
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fukuoka 1863967, Fukuoka 1863958 814 0180
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Asahikawa, Hokkaido 0708644
    Japan

    Site Not Available

  • Novartis Investigative Site

    Asahikawa 2130629, Hokkaido 2130037 070-8644
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kita-gun, Kagawa-ken 7610793
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sagamihara, Kanagawa 2520392
    Japan

    Site Not Available

  • Novartis Investigative Site

    Yokohama, Kanagawa 222-0036
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nagano, Nagano 3808582
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nagano 1856215, Nagano 1856210 380-8582
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kawachi-Nagano, Osaka 5868521
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kawachi-Nagano 6825498, Osaka 1853904 586-8521
    Japan

    Site Not Available

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo 1138431
    Japan

    Site Not Available

  • Novartis Investigative Site

    Bunkyo ku, Tokyo 113-8431
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fuchū, Tokyo 1838524
    Japan

    Site Not Available

  • Novartis Investigative Site

    Ōme, Tokyo 198-0042
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fuchū 11611632, Tokyo 1850144 183-8524
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Chūō, Yamanashi 409-3898
    Japan

    Site Not Available

  • Novartis Investigative Site

    Okayama, 700-8607
    Japan

    Site Not Available

  • Novartis Investigative Site

    Osaka, 5340021
    Japan

    Site Not Available

  • Novartis Investigative Site

    Osaka 1853909, 534-0021
    Japan

    Site Not Available

  • Novartis Investigative Site

    Guadalajara, Jalisco 44650
    Mexico

    Site Not Available

  • Novartis Investigative Site

    Almelo, Overijssel 7609 PP
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Rotterdam, South Holland 3079 DZ
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Lublin, 20-607
    Poland

    Site Not Available

  • Novartis Investigative Site

    Warsaw, 02-665
    Poland

    Site Not Available

  • Novartis Investigative Site

    Warsaw 756135, 02-665
    Poland

    Site Not Available

  • Novartis Investigative Site

    Warszawa, 02 118
    Poland

    Active - Recruiting

  • Novartis Investigative Site

    Cape Town, Western Cape 7500
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Cape Town 3369157, Western Cape 1085599 7500
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Sabadell, Barcelona 08208
    Spain

    Site Not Available

  • Novartis Investigative Site

    Bilbao, Bizkaia 48013
    Spain

    Site Not Available

  • Novartis Investigative Site

    A Coruña, 15006
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid, 28009
    Spain

    Site Not Available

  • Novartis Investigative Site

    Seville, 41013
    Spain

    Site Not Available

  • Novartis Investigative Site

    Valencia, 46010
    Spain

    Site Not Available

  • Novartis Investigative Site

    Sankt Gallen, 9007
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Barnet, EN5 3DJ
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Wolverhampton, WV10 0QP
    United Kingdom

    Site Not Available

  • Arizona Arthritis and Rheumatology Associates PLLC

    Avondale, Arizona 85392
    United States

    Site Not Available

  • Sun Valley Arthritis Center Ltd

    Peoria, Arizona 85381
    United States

    Site Not Available

  • Center for Rheumatology Research

    West Hills, California 91307
    United States

    Site Not Available

  • Millennium Clinical Trials

    Westlake Village, California 91361
    United States

    Site Not Available

  • Rheumatology Associates of South Florida

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Sarasota Arthritis Research Center

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • West Broward Rheumatology Associates Inc

    Tamarac, Florida 33321
    United States

    Site Not Available

  • Arthritis Center of North Georgia

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • Klein and Associates

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Clinical Research Inst of MI

    Saint Clair Shores, Michigan 48081
    United States

    Site Not Available

  • Clinical Research Institute of Michigan LLC

    Saint Clair Shores, Michigan 48081
    United States

    Active - Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Paramount Med Rsrch and Consult LLC

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • Accurate Clinical Research Inc

    Houston, Texas 77089
    United States

    Site Not Available

  • Prolato Clinical Research Center

    Houston, Texas 77054
    United States

    Site Not Available

  • Accurate Clinical Research Inc .

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Advanced Rheumatology of Houston

    Spring, Texas 77382
    United States

    Site Not Available

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