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

Last updated: March 28, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - 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: 300
Treatment Group(s): 1
Primary Treatment: Secukinumab
Phase: 3
Study Start date:
June 28, 2024
Estimated Completion Date:
February 10, 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

    Active - Recruiting

  • Novartis Investigative Site

    Southport, Queensland 4215
    Australia

    Active - Recruiting

  • Novartis Investigative Site

    Heidelberg Heights, Victoria 3081
    Australia

    Active - Recruiting

  • Novartis Investigative Site

    Parramatta, 2150
    Australia

    Active - Recruiting

  • Novartis Investigative Site

    Quebec, G1V 3M7
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Vina del Mar, Region De Valparaiso 2520598
    Chile

    Site Not Available

  • Novartis Investigative Site

    Santiago, 7500571
    Chile

    Active - Recruiting

  • Novartis Investigative Site

    Barranquilla, 080020
    Colombia

    Active - Recruiting

  • Novartis Investigative Site

    Bogota, 110221
    Colombia

    Active - Recruiting

  • Novartis Investigative Site

    Brno, 63800
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Praha 2, 128 50
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Uherske Hradiste, 686 01
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Gandrup, 9362
    Denmark

    Active - Recruiting

  • Novartis Investigative Site

    Vejle, DK-7100
    Denmark

    Active - Recruiting

  • Novartis Investigative Site

    Toulon Cedex 9, Val De Marne 83800
    France

    Active - Recruiting

  • Novartis Investigative Site

    Cholet, 49325
    France

    Active - Recruiting

  • Novartis Investigative Site

    Dijon, 21034
    France

    Active - Recruiting

  • Novartis Investigative Site

    Reims, 51092
    France

    Active - Recruiting

  • Novartis Investigative Site

    Strasbourg, 67000
    France

    Active - Recruiting

  • Novartis Investigative Site

    Toulouse, 31059
    France

    Active - Recruiting

  • Novartis Investigative Site

    Berlin, 13353
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Herne, 44649
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Ratingen, 40878
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Budapest, 1027
    Hungary

    Active - Recruiting

  • Novartis Investigative Site

    Szeged, 6720
    Hungary

    Active - Recruiting

  • Novartis Investigative Site

    Veszprem, 8200
    Hungary

    Active - Recruiting

  • Novartis Investigative Site

    Perugia, PG 06129
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Pavia, PV 27100
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Reggio Emilia, RE 42123
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Fukuoka city, Fukuoka 814 0180
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Asahikawa-city, Hokkaido 070-8644
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kawachinagano, Osaka 586-8521
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Bunkyo ku, Tokyo 113-8431
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Fuchu, Tokyo 183-8524
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Ome, Tokyo 198-0042
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Shimonoseki, Yamaguchi 750-0041
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Chuo, Yamanashi 409-3898
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Okayama, 700-8607
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Ashrafieh, 166830
    Lebanon

    Active - Recruiting

  • Novartis Investigative Site

    Guadalajara, Jalisco 44650
    Mexico

    Active - Recruiting

  • Novartis Investigative Site

    Sabadell, Barcelona 08208
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Valencia, Comunidad Valenciana 46010
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    La Coruna, Galicia 15006
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Madrid, 28009
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Basel, 4031
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    St Gallen, 9007
    Switzerland

    Active - Recruiting

  • Arizona Arthritis and Rheumatology Associates PLLC

    Avondale, Arizona 85392
    United States

    Active - Recruiting

  • Sun Valley Arthritis Center Ltd

    Peoria, Arizona 85381
    United States

    Active - Recruiting

  • Center for Rheumatology Research

    West Hills, California 91307
    United States

    Active - Recruiting

  • Rheumatology Associates of South Florida

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • Sarasota Arthritis Res Ctr

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • Sarasota Arthritis Research Center

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • West Broward Rheumatology Associates Inc

    Tamarac, Florida 33321
    United States

    Active - Recruiting

  • Arthritis Center of North Georgia

    Gainesville, Georgia 30501
    United States

    Active - Recruiting

  • Klein and Associates

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Clinical Research Inst of MI

    Saint Clair Shores, Michigan 48081
    United States

    Active - Recruiting

  • Clinical Research Institute of Michigan LLC

    Saint Clair Shores, Michigan 48081
    United States

    Active - Recruiting

  • Shores Rheumatology

    Saint Clair Shores, Michigan 48081
    United States

    Site Not Available

  • Accurate Clinical Research Inc

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Accurate Clinical Research Inc .

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Advanced Rheumatology of Houston

    Spring, Texas 77382
    United States

    Active - Recruiting

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