- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06331312
Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR) (REPLENISH-EXT)
A Multi-center, Open-label Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Safety and Tolerability in Polymyalgia Rheumatica (PMR)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Novartis Pharmaceuticals
- Phone Number: 1-888-669-6682
- Email: novartis.email@novartis.com
Study Contact Backup
- Name: Novartis Pharmaceuticals
- Phone Number: +41613241111
Study Locations
-
-
-
Parramatta, Australia, 2150
- Recruiting
- Novartis Investigative Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / 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.
|
2 x 150mg/1mL PFS secukinumab
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidences of treatment emergent adverse events (AEs) and serious adverse events (SAEs)
Time Frame: After the first dose of study treatment and within 84 days after the last dose
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Skin Diseases
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Muscular Diseases
- Vasculitis
- Skin Diseases, Vascular
- Vasculitis, Central Nervous System
- Arteritis
- Polymyalgia Rheumatica
- Giant Cell Arteritis
Other Study ID Numbers
- CAIN457C22301E1
- 2023-508077-85-00 (Other Identifier: EU CT number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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 review 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 availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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