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A multi-center, open-label extension study of subcutaneous secukinumab to evaluate the long-term safety and tolerability in polymyalgia rheumatica (PMR) (CAIN457C22301E1)

A multi-center, open-label extension study of subcutaneous secukinumab to evaluate the long-term safety and tolerability in polymyalgia rheumatica (PMR) (CAIN457C22301E1)

Maruyama Hideki

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

rinshoshiken.toroku@novartis.com

Maruyama Hideki

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku@novartis.com

Recruiting

May. 27, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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.

- 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

Both

Polymyalgia Rheumatica

Biological: Secukinumab
2 x 150mg/1mL PFS secukinumab

Incidences of treatment emergent adverse events (AEs) and serious adverse events (SAEs)

+81-428-22-3191

April. 05, 2024

Yes

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

Australia