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

PHASE3ACTIVE_NOT_RECRUITING

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

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. 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
  2. who have experienced a relapse during the treatment-free follow-up period of the core study, AND
  3. who have not been on rescue treatment.
  4. The participant would potentially derive benefit from secukinumab, and the benefit outweighs the risk, based on the investigator's judgement.

Exclusion criteria

  1. Use of prohibited medications, as specified in the protocol
  2. History of ongoing, chronic or recurrent infectious disease (i.e., human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV), active tuberculosis infection (TB))
  3. 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).
  4. Live vaccinations (e.g., monkey pox vaccine, oral polio vaccine, varicella/zoster vaccines) within 6 weeks prior to Baseline
  5. Subjects whose participation in the extension study could expose them to an undue safety risk

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE3

trial

Study ID

NCT06331312

Intervention or treatment

BIOLOGICAL: Secukinumab

Conditions

  • Polymyalgia Rheumatica

  • Condition: Polymyalgia Rheumatica

  • BIOLOGICAL: Secukinumab

  • Southport, Queensland, Australia and more

  • Sponsor: Novartis Pharmaceuticals

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Novartis Investigative Site

Select from list below to view details:

  • Novartis Investigative Site

    Southport, Queensland, Australia

  • Novartis Investigative Site

    Heidelberg Heights, Victoria, Australia

  • Novartis Investigative Site

    Parramatta, Australia

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Who is running the clinical trial?

NP

Novartis Pharmaceuticals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Secukinumab 300mg
  • 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.
Biological: Secukinumab

    What is the study measuring?

    Primary Outcome

    MeasureDescriptionTime Frame
    Incidences of treatment emergent adverse events (AEs) and serious adverse events (SAEs)The number and percentage of participants with treatment emergent AEs/SAEs will be summarized. No hypothesis testing will be performed.After the first dose of study treatment and within 84 days after the last dose

    Secondary Outcome

    Are you running this trial?If you're a clinic or sponsor, you can claim this study.
    Claim this trial

    References

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

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