Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR) (NCT06331312) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)
United States161 participantsStarted 2024-06-28
Plain-language 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.
Who can participate
Age range50 Years – 100 Years
SexALL
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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
What they're measuring
1
Incidences of treatment emergent adverse events (AEs) and serious adverse events (SAEs)
Timeframe: After the first dose of study treatment and within 84 days after the last dose