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Long-term safety assessment of secukinumab for polymyalgia rheumatica

A Multi-center, Open-label Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Safety and Tolerability in Polymyalgia Rheumatica (PMR)

Phase 3 Interventional Novartis · NCT06331312

This study is testing how safe and well-tolerated the medication secukinumab is for people with polymyalgia rheumatica over a two-year period.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment300 (estimated)
Ages50 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionssecukinumab
Locations81 sites (Avondale, Arizona and 80 other locations)
Trial IDNCT06331312 on ClinicalTrials.gov

What this trial studies

This study evaluates the long-term safety and tolerability of secukinumab, a monoclonal antibody, in patients with polymyalgia rheumatica who have previously participated in a core study. It includes a screening period of up to 4 weeks, followed by a 2-year treatment period divided into two phases, with regular follow-up visits for monitoring. Participants will receive secukinumab and will be assessed for any adverse effects throughout the study duration, including a treatment-free follow-up period of 16 weeks after the last dose.

Who should consider this trial

Good fit: Ideal candidates are patients who have completed a prior study of secukinumab and experienced a relapse during the treatment-free follow-up.

Not a fit: Patients with ongoing infections, certain malignancies, or those on prohibited medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety of secukinumab, potentially improving treatment options for patients with polymyalgia rheumatica.

How similar studies have performed: Other studies have shown promising results with secukinumab in treating autoimmune conditions, suggesting potential for success in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Avondale, Arizona and 80 other locations

+31 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Polymyalgia Rheumaticasecukinumabmonoclonal antibodysubcutaneousextensionlong-termsafetyREPLENISH
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.