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

Polymyalgia Rheumatica Clinical Trial

— REPLENISH-EXT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06331312
• Other study ID #: CAIN457C22301E1
• Secondary ID: 2023-508077-85-0
• Status: Recruiting
• Phase: Phase 3
• Start date: April 10, 2024
• Est. completion date: May 8, 2028

Study information

• Verified date: April 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: 1-888-669-6682
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 8, 2028
• Est. primary completion date: March 13, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

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

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Parramatta

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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