Polymyalgia RheumaticaPhase 3REPLENISH-EXTNCT06331312
Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)
A Phase 3 study testing Secukinumab in people with Polymyalgia Rheumatica, run by Novartis Pharmaceuticals at 85 sites in 22 countries.
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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Polymyalgia Rheumatica
- What is being tested?
- Secukinumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 85 sitesin 22 countries
- Study dates
- 28 Jun 2024to 8 May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
85 sites in 22 countries.
85 sites in 22 countries
United States13 sites
Arizona Arthritis and Rheumatology Associates PLLC
Avondale, Arizona, 85392
Rheumatology Associates of South Florida
Boca Raton, Florida, 33486
Klein and Associates
Hagerstown, Maryland, 21740
Prolato Clinical Research Center
Houston, Texas, 77054
Accurate Clinical Research Inc
Houston, Texas, 77089
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Paramount Med Rsrch and Consult LLC
Middleburg Heights, Ohio, 44130
Sun Valley Arthritis Center Ltd
Peoria, Arizona, 85381
Clinical Research Inst of MI
Saint Clair Shores, Michigan, 48081
West Broward Rheumatology Associates Inc
Tamarac, Florida, 33321
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382
Millennium Clinical Trials
Westlake Village, California, 91361
Center for Rheumatology Research
Woodland Hills, California, 91364
Japan13 sites
Novartis Investigative Site
Asahikawa, Hokkaido, 0708644
Novartis Investigative Site
Bunkyo Ku, Tokyo, 1138431
Novartis Investigative Site
Chūō, Yamanashi, 4093898
Novartis Investigative Site
Fuchū, Tokyo, 1838524
Novartis Investigative Site
Fukuoka, Fukuoka, 8140180
Novartis Investigative Site
Kawachi-Nagano, Osaka, 5868521
Novartis Investigative Site
Kita-gun, Kagawa-ken, 7610793
Novartis Investigative Site
Nagano, Nagano, 3808582
Novartis Investigative Site
Okayama, 7008607
Novartis Investigative Site
Ōme, Tokyo, 1980042
Novartis Investigative Site
Osaka, Osaka, 5340021
Novartis Investigative Site
Sagamihara, Kanagawa, 2520392
Novartis Investigative Site
Yokohama, Kanagawa, 2220036
France10 sites
Novartis Investigative Site
Brest, 29200
Novartis Investigative Site
Cholet, 49325
Novartis Investigative Site
Colmar, 68024
Novartis Investigative Site
Dijon, 21000
Novartis Investigative Site
Le Mans, 72000
Novartis Investigative Site
Nantes, 44093
Novartis Investigative Site
Reims, 51092
Novartis Investigative Site
Strasbourg, 67000
Novartis Investigative Site
Toulon, Val De Marne, 83800
Novartis Investigative Site
Toulouse, 31059
Czechia6 sites
Novartis Investigative Site
Brno, 638 00
Novartis Investigative Site
Hlučín, 748 01
Novartis Investigative Site
Prague, Czech Republic, 140 00
Novartis Investigative Site
Prague, 128 00
Novartis Investigative Site
Prague, 140 00
Novartis Investigative Site
Uherské Hradiště, 686 01
Spain6 sites
Novartis Investigative Site
A Coruña, 15006
Novartis Investigative Site
Bilbao, Bizkaia, 48013
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Sabadell, Barcelona, 08208
Novartis Investigative Site
Seville, 41013
Novartis Investigative Site
Valencia, 46010
Germany5 sites
Novartis Investigative Site
Berlin, 13125
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Novartis Investigative Site
Herne, 44649
Novartis Investigative Site
Würzburg, Bavaria, 97080
Brazil3 sites
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90480-000
Novartis Investigative Site
São Paulo, São Paulo, 04038-002
Novartis Investigative Site
São Paulo, 01409-902
Chile3 sites
Novartis Investigative Site
Santiago, Santiago Metropolitan, 7500571
Novartis Investigative Site
Santiago, Santiago Metropolitan, 8420383
Novartis Investigative Site
Viña del Mar, Valparaiso, 2531172
Denmark3 sites
Novartis Investigative Site
Esbjerg, 6700
Novartis Investigative Site
Gandrup, 9362
Novartis Investigative Site
Vejle, 7100
Hungary3 sites
Novartis Investigative Site
Budapest, 1027
Novartis Investigative Site
Szeged, 6725
Novartis Investigative Site
Veszprém, 8200
Poland3 sites
Novartis Investigative Site
Lublin, 20-607
Novartis Investigative Site
Warsaw, 02-118
Novartis Investigative Site
Warsaw, 02-665
Argentina2 sites
Novartis Investigative Site
Buenos Aires, C1055AAF
Novartis Investigative Site
Quilmes, Buenos Aires, B1878GEG
Australia2 sites
Novartis Investigative Site
Heidelberg Heights, Victoria, 3081
Novartis Investigative Site
Parramatta, New South Wales, 2150
Italy2 sites
Novartis Investigative Site
Milan, MI, 20100
Novartis Investigative Site
Perugia, PG, 06129
Netherlands2 sites
Novartis Investigative Site
Almelo, Overijssel, 7609 PP
Novartis Investigative Site
Rotterdam, South Holland, 3079 DZ
South Africa2 sites
Novartis Investigative Site
Cape Town, Western Cape, 7405
Novartis Investigative Site
Cape Town, Western Cape, 7500
United Kingdom2 sites
Novartis Investigative Site
Barnet, EN5 3DJ
Novartis Investigative Site
Wolverhampton, WV10 0QP
About this study
Official title: A Multi-center, Open-label Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Safety and Tolerability in Polymyalgia Rheumatica (PMR)
The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica.
Read the 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.
- Conditions
- Polymyalgia Rheumatica
- Being tested
- Secukinumab
- Keywords
- Polymyalgia Rheumatica (PMR), secukinumab, monoclonal antibody, subcutaneous (s.c.), extension, long-term, safety, REPLENISH
- Medical subject headings
- Polymyalgia Rheumatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabBiological
2 x 150mg/1mL PFS secukinumab
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab 300mg | Experimental | 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. Receives: Biological: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After the first dose of study treatment and within 84 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start28 Jun 2024
- Primary completion8 May 2028 (estimated)
- Study completion8 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polymyalgia RheumaticaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331312
- Sponsor's protocol ID
- CAIN457C22301E1
- Other IDs
- 2023-508077-85-00, 2023
- Acronym
- REPLENISH-EXT
- Status last verified
- Oct 2026
- First submitted
- 20 Mar 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Safety and Tolerability in Polymyalgia Rheumatica (PMR)
- ClinicalTrials.gov ID
- NCT06331312
- Acronym / sponsor ID
- REPLENISH-EXT / CAIN457C22301E1
- Conditions
- Polymyalgia Rheumatica
- Keywords
- Polymyalgia Rheumatica (PMR), secukinumab, monoclonal antibody, subcutaneous (s.c.), extension, long-term, safety, REPLENISH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 8 May 2028 (estimated)
- Study completion
- 8 May 2028 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secukinumab 300mg | Experimental | Biological: SecukinumabAll 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. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- The participant would potentially derive benefit from secukinumab, and the benefit outweighs the risk, based on the investigator's judgement.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secukinumab2 x 150mg/1mL PFS secukinumab | Biological | Secukinumab 300mg |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: 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 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
85 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Secukinumab in people with Polymyalgia Rheumatica, run by Novartis Pharmaceuticals at 85 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in United States, Japan, France, Czechia, Spain and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.