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

April 15, 2026 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Active, not recruiting

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

Interventional

Enrollment (Actual)

161

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1055AAF
        • Novartis Investigative Site
    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina, B1878GEG
        • Novartis Investigative Site
  • Australia
    • New South Wales
      • Parramatta, New South Wales, Australia, 2150
        • Novartis Investigative Site
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Novartis Investigative Site
    • Victoria
      • Heidelberg Heights, Victoria, Australia, 3081
        • Novartis Investigative Site
  • Belgium
      • Liège, Belgium, 4000
        • Novartis Investigative Site
  • Brazil
      • São Paulo, Brazil, 01409-902
        • Novartis Investigative Site
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
        • Novartis Investigative Site
    • São Paulo
      • São Paulo, São Paulo, Brazil, 04038-002
        • Novartis Investigative Site
  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V 3M7
        • Novartis Investigative Site
  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7500571
        • Novartis Investigative Site
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Novartis Investigative Site
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2531172
        • Novartis Investigative Site
  • Colombia
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080002
        • Novartis Investigative Site
      • Barranquilla, Atlántico, Colombia, 080020
        • Novartis Investigative Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 110221
        • Novartis Investigative Site
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760042
        • Novartis Investigative Site
  • Czechia
      • Brno, Czechia, 638 00
        • Novartis Investigative Site
      • Hlučín, Czechia, 748 01
        • Novartis Investigative Site
      • Prague, Czechia, 128 00
        • Novartis Investigative Site
      • Prague, Czechia, 140 00
        • Novartis Investigative Site
      • Uherské Hradiště, Czechia, 686 01
        • Novartis Investigative Site
      • Zlín, Czechia, 760 01
        • Novartis Investigative Site
    • Czech Republic
      • Prague, Czech Republic, Czechia, 140 00
        • Novartis Investigative Site
  • Denmark
      • Esbjerg, Denmark, 6700
        • Novartis Investigative Site
      • Gandrup, Denmark, 9362
        • Novartis Investigative Site
      • Vejle, Denmark, DK-7100
        • Novartis Investigative Site
  • France
      • Brest, France, 29200
        • Novartis Investigative Site
      • Cholet, France, 49325
        • Novartis Investigative Site
      • Colmar, France, 68024
        • Novartis Investigative Site
      • Dijon, France, 21000
        • Novartis Investigative Site
      • Le Mans, France, 72000
        • Novartis Investigative Site
      • Montpellier, France, 34295
        • Novartis Investigative Site
      • Nantes, France, 44093
        • Novartis Investigative Site
      • Reims, France, 51092
        • Novartis Investigative Site
      • Strasbourg, France, 67000
        • Novartis Investigative Site
      • Toulouse, France, 31059
        • Novartis Investigative Site
    • Val De Marne
      • Toulon, Val De Marne, France, 83800
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13125
        • Novartis Investigative Site
      • Berlin, Germany, 13353
        • Novartis Investigative Site
      • Herne, Germany, 44649
        • Novartis Investigative Site
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • Novartis Investigative Site
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1027
        • Novartis Investigative Site
      • Szeged, Hungary, 6725
        • Novartis Investigative Site
      • Veszprém, Hungary, 8200
        • Novartis Investigative Site
  • Italy
    • BZ
      • Bolzano, BZ, Italy, 39100
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italy, 20100
        • Novartis Investigative Site
    • PG
      • Perugia, PG, Italy, 06129
        • Novartis Investigative Site
  • Japan
      • Okayama, Japan, 700-8607
        • Novartis Investigative Site
      • Osaka, Japan, 5340021
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 8140180
        • Novartis Investigative Site
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 0708644
        • Novartis Investigative Site
    • Kagawa-ken
      • Kita-gun, Kagawa-ken, Japan, 7610793
        • Novartis Investigative Site
    • Kanagawa
      • Sagamihara, Kanagawa, Japan, 252-0392
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 222-0036
        • Novartis Investigative Site
    • Nagano
      • Nagano, Nagano, Japan, 3808582
        • Novartis Investigative Site
    • Osaka
      • Kawachi-Nagano, Osaka, Japan, 5868521
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo Ku, Tokyo, Japan, 1138431
        • Novartis Investigative Site
      • Fuchū, Tokyo, Japan, 1838524
        • Novartis Investigative Site
      • Ōme, Tokyo, Japan, 198-0042
        • Novartis Investigative Site
    • Yamanashi
      • Chūō, Yamanashi, Japan, 409-3898
        • Novartis Investigative Site
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Novartis Investigative Site
  • Netherlands
    • Overijssel
      • Almelo, Overijssel, Netherlands, 7609 PP
        • Novartis Investigative Site
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3079 DZ
        • Novartis Investigative Site
  • Poland
      • Lublin, Poland, 20-607
        • Novartis Investigative Site
      • Warsaw, Poland, 02-665
        • Novartis Investigative Site
      • Warsaw, Poland, 02-118
        • Novartis Investigative Site
  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7500
        • Novartis Investigative Site
      • Cape Town, Western Cape, South Africa, 7405
        • Novartis Investigative Site
  • Spain
      • A Coruña, Spain, 15006
        • Novartis Investigative Site
      • Madrid, Spain, 28009
        • Novartis Investigative Site
      • Seville, Spain, 41013
        • Novartis Investigative Site
      • Valencia, Spain, 46010
        • Novartis Investigative Site
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Novartis Investigative Site
    • Bizkaia
      • Bilbao, Bizkaia, Spain, 48013
        • Novartis Investigative Site
  • Switzerland
      • Sankt Gallen, Switzerland, 9007
        • Novartis Investigative Site
  • United Kingdom
      • Barnet, United Kingdom, EN5 3DJ
        • Novartis Investigative Site
      • Hull, United Kingdom, HU3 2RW
        • Novartis Investigative Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Novartis Investigative Site
  • United States
    • Arizona
      • Avondale, Arizona, United States, 85392
        • Arizona Arthritis and Rheumatology Associates PLLC
      • Peoria, Arizona, United States, 85381
        • Sun Valley Arthritis Center Ltd
    • California
      • Santa Monica, California, United States, 90404
        • Orrin Troum MD and Medical Associates
      • West Hills, California, United States, 91307
        • Center for Rheumatology Research
      • Westlake Village, California, United States, 91361
        • Millennium Clinical Trials
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Rheumatology Associates of South Florida
      • Gainesville, Florida, United States, 32610
        • UF Health Cancer Center
      • Sarasota, Florida, United States, 34239
        • Sarasota Arthritis Res Ctr
      • Tamarac, Florida, United States, 33321
        • West Broward Rheumatology Associates Inc
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Arthritis Center of North Georgia
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Klein and Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Saint Clair Shores, Michigan, United States, 48081
        • Clinical Research Inst of MI
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Kansas City Physician Partners
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Med Rsrch and Consult LLC
    • Texas
      • Houston, Texas, United States, 77054
        • Prolato Clinical Research Center
      • San Antonio, Texas, United States, 78229
        • Accurate Clinical Research Inc
      • Spring, Texas, United States, 77382
        • Advanced Rheumatology of Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Biological: Secukinumab
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

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2024

Primary Completion (Estimated)

August 22, 2028

Study Completion (Estimated)

August 22, 2028

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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)?

YES

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

Yes

Studies a U.S. FDA-regulated device product

No

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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