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Active, not recruitingPhase 3

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

Key facts

Who runs it
Novartis Pharmaceuticals
Where
Avondale, Boca Raton, Hagerstown, Houston, Lebanon, Middleburg Heights, Peoria, Saint Clair Shores, Tamarac, The Woodlands, Westlake Village, and Woodland Hills, United StatesSee the 13 sitesAlso in 21 other countries, 91 sites
Status
Active, not recruiting
Phase
Phase 3
People taking part
162 people enrolled
Started
28 Jun 2024
Expected to end
8 May 2028
Type of study
Interventional
Treatments tested
  • Secukinumab
Record updated
14 October 2026

Who can take part

Age
50 years to 100 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Use of prohibited medications, as specified in the protocol
  • Live vaccinations (e.g., monkey pox vaccine, oral polio vaccine, varicella/zoster vaccines) within 6 weeks prior to Baseline
  • 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)
  • Subjects whose participation in the extension study could expose them to an undue safety risk

Where in United States

Also in 21 other countries, 91 sites

  • Arizona Arthritis and Rheumatology Associates PLLCAvondale, United States
  • Rheumatology Associates Of South FloridaBoca Raton, United States
  • Klein and AssociatesHagerstown, United States
  • Accurate Clinical Research, IncHouston, United States
  • Prolato Clinical Research CenterHouston, United States
  • Dartmouth Hitchcock Medical CenterLebanon, United States
  • Paramount Med Rsrch and Consult LLCMiddleburg Heights, United States
  • Sun Valley Arthritis Center LtdPeoria, United States
  • Clinical Research Inst of MISaint Clair Shores, United States
  • West Broward Rheumatology Associates, Inc.Tamarac, United States
  • Advanced Rheumatology of HoustonThe Woodlands, United States
  • Millennium Clinical TrialsWestlake Village, United States
  • Center for Rheumatology ResearchWoodland Hills, United States

About the trial

What the trial wants to find out

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

The group in the trial

  • Secukinumab 300mgTreatment being tested

    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.

    Treatment: Secukinumab

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Multi-center, Open-label Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Safety and Tolerability in Polymyalgia Rheumatica (PMR)
Record updated
14 October 2026