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Clinical Trials in Germany / NCT06331312
Active, not recruiting Phase 3

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

NCT06331312 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2024-06-28
Last updated
2026-08-21

Condition(s) studied

Polymyalgia Rheumatica

Investigational drug(s) / intervention(s)

Secukinumab →

Secukinumab: 2 x 150mg/1mL PFS secukinumab

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

Sex
ALL
Min age
50 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (85)

FacilityCityRegionStatus
Arizona Arthritis and Rheumatology Associates PLLC Avondale Arizona
Sun Valley Arthritis Center Ltd Peoria Arizona
Millennium Clinical Trials Westlake Village California
Center for Rheumatology Research Woodland Hills California
Rheumatology Associates of South Florida Boca Raton Florida
West Broward Rheumatology Associates Inc Tamarac Florida
Klein and Associates Hagerstown Maryland
Clinical Research Inst of MI Saint Clair Shores Michigan
Dartmouth Hitchcock Medical Center Lebanon New Hampshire
Paramount Med Rsrch and Consult LLC Middleburg Heights Ohio
Prolato Clinical Research Center Houston Texas
Accurate Clinical Research Inc Houston Texas
Advanced Rheumatology of Houston The Woodlands Texas
Novartis Investigative Site Quilmes Buenos Aires
Novartis Investigative Site Buenos Aires Argentina
Novartis Investigative Site Parramatta New South Wales
Novartis Investigative Site Heidelberg Heights Victoria
Novartis Investigative Site Liège Belgium
Novartis Investigative Site Porto Alegre Rio Grande do Sul
Novartis Investigative Site São Paulo São Paulo
Novartis Investigative Site São Paulo Brazil
Novartis Investigative Site Québec Quebec
Novartis Investigative Site Santiago Santiago Metropolitan
Novartis Investigative Site Santiago Santiago Metropolitan
Novartis Investigative Site Viña del Mar Valparaiso
Novartis Investigative Site Bogota Cundinamarca
Novartis Investigative Site Prague Czech Republic
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 Esbjerg Denmark
Novartis Investigative Site Gandrup Denmark
Novartis Investigative Site Vejle Denmark
Novartis Investigative Site Toulon Val De Marne
Novartis Investigative Site Brest France
Novartis Investigative Site Cholet France
Novartis Investigative Site Colmar France
Novartis Investigative Site Dijon France

+ 45 more sites — see the full list on the official registry below.

On this site

📄 Cosentyx (secukinumab) drug profile →

More Novartis Pharmaceuticals trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06331312 on ClinicalTrials.gov ↗ ← All trials in Germany