Frontlight ResearchEarly access
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
- Trial code
- 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