MedDataX Logo

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

NCT ID: NCT06331312

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-28

Study Completion Date

2028-08-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Polymyalgia Rheumatica

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Polymyalgia Rheumatica (PMR) secukinumab monoclonal antibody subcutaneous (s.c.) extension long-term safety REPLENISH

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Secukinumab

Intervention Type BIOLOGICAL

2 x 150mg/1mL PFS secukinumab

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Secukinumab

2 x 150mg/1mL PFS secukinumab

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arizona Arthritis and Rheumatology Associates PLLC

Avondale, Arizona, United States

Site Status ACTIVE_NOT_RECRUITING

Sun Valley Arthritis Center Ltd

Peoria, Arizona, United States

Site Status ACTIVE_NOT_RECRUITING

Orrin Troum MD and Medical Associates

Santa Monica, California, United States

Site Status RECRUITING

Center for Rheumatology Research

West Hills, California, United States

Site Status ACTIVE_NOT_RECRUITING

Millennium Clinical Trials

Westlake Village, California, United States

Site Status ACTIVE_NOT_RECRUITING

Rheumatology Associates of South Florida

Boca Raton, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

UF Health Cancer Center

Gainesville, Florida, United States

Site Status RECRUITING

Sarasota Arthritis Res Ctr

Sarasota, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

West Broward Rheumatology Associates Inc

Tamarac, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Arthritis Center of North Georgia

Gainesville, Georgia, United States

Site Status RECRUITING

Klein and Associates

Hagerstown, Maryland, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Clinical Research Inst of MI

Saint Clair Shores, Michigan, United States

Site Status RECRUITING

Kansas City Physician Partners

Kansas City, Missouri, United States

Site Status RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status RECRUITING

Paramount Med Rsrch and Consult LLC

Middleburg Heights, Ohio, United States

Site Status RECRUITING

Prolato Clinical Research Center

Houston, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Accurate Clinical Research Inc

San Antonio, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Advanced Rheumatology of Houston

Spring, Texas, United States

Site Status COMPLETED

Novartis Investigative Site

Quilmes, Buenos Aires, Argentina

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Buenos Aires, , Argentina

Site Status RECRUITING

Novartis Investigative Site

Parramatta, New South Wales, Australia

Site Status RECRUITING

Novartis Investigative Site

Southport, Queensland, Australia

Site Status RECRUITING

Novartis Investigative Site

Heidelberg Heights, Victoria, Australia

Site Status RECRUITING

Novartis Investigative Site

Leuven, , Belgium

Site Status RECRUITING

Novartis Investigative Site

Liège, , Belgium

Site Status RECRUITING

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

São Paulo, , Brazil

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Québec, Quebec, Canada

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Viña del Mar, Región de Valparaíso, Chile

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Santiago, Santiago Metropolitan, Chile

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Santiago, Santiago Metropolitan, Chile

Site Status WITHDRAWN

Novartis Investigative Site

Santiago, Santiago Metropolitan, Chile

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Barranquilla, Atlántico, Colombia

Site Status RECRUITING

Novartis Investigative Site

Barranquilla, Atlántico, Colombia

Site Status RECRUITING

Novartis Investigative Site

Bogota, Cundinamarca, Colombia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Cali, Valle del Cauca Department, Colombia

Site Status RECRUITING

Novartis Investigative Site

Prague, Czech Republic, Czechia

Site Status RECRUITING

Novartis Investigative Site

Brno, , Czechia

Site Status RECRUITING

Novartis Investigative Site

Hlučín, , Czechia

Site Status RECRUITING

Novartis Investigative Site

Prague, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Prague, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Uherské Hradiště, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Zlín, , Czechia

Site Status RECRUITING

Novartis Investigative Site

Esbjerg, , Denmark

Site Status RECRUITING

Novartis Investigative Site

Gandrup, , Denmark

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Vejle, , Denmark

Site Status RECRUITING

Novartis Investigative Site

Limoges, Haute Vienne, France

Site Status RECRUITING

Novartis Investigative Site

Toulon, Val De Marne, France

Site Status RECRUITING

Novartis Investigative Site

Brest, , France

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Cholet, , France

Site Status RECRUITING

Novartis Investigative Site

Colmar, , France

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Dijon, , France

Site Status RECRUITING

Novartis Investigative Site

Le Mans, , France

Site Status RECRUITING

Novartis Investigative Site

Montpellier, , France

Site Status RECRUITING

Novartis Investigative Site

Nantes, , France

Site Status RECRUITING

Novartis Investigative Site

Reims, , France

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Strasbourg, , France

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Toulouse, , France

Site Status RECRUITING

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Würzburg, Bavaria, Germany

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Dresden, Saxony, Germany

Site Status RECRUITING

Novartis Investigative Site

Berlin, , Germany

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Berlin, , Germany

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Herne, , Germany

Site Status RECRUITING

Novartis Investigative Site

Ratingen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Rendsburg, , Germany

Site Status RECRUITING

Novartis Investigative Site

Budapest, , Hungary

Site Status RECRUITING

Novartis Investigative Site

Szeged, , Hungary

Site Status RECRUITING

Novartis Investigative Site

Veszprém, , Hungary

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Ramat Gan, , Israel

Site Status RECRUITING

Novartis Investigative Site

Bolzano, BZ, Italy

Site Status RECRUITING

Novartis Investigative Site

Milan, MI, Italy

Site Status RECRUITING

Novartis Investigative Site

Milan, MI, Italy

Site Status WITHDRAWN

Novartis Investigative Site

Perugia, PG, Italy

Site Status RECRUITING

Novartis Investigative Site

Pavia, PV, Italy

Site Status WITHDRAWN

Novartis Investigative Site

Reggio Emilia, RE, Italy

Site Status RECRUITING

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Site Status RECRUITING

Novartis Investigative Site

Asahikawa, Hokkaido, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Kita-gun, Kagawa-ken, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Sagamihara, Kanagawa, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Nagano, Nagano, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Kawachi-Nagano, Osaka, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Fuchū, Tokyo, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Ōme, Tokyo, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Shimonoseki, Yamaguchi, Japan

Site Status WITHDRAWN

Novartis Investigative Site

Chūō, Yamanashi, Japan

Site Status RECRUITING

Novartis Investigative Site

Okayama, , Japan

Site Status RECRUITING

Novartis Investigative Site

Osaka, , Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Beirut, , Lebanon

Site Status WITHDRAWN

Novartis Investigative Site

Guadalajara, Jalisco, Mexico

Site Status RECRUITING

Novartis Investigative Site

Almelo, Overijssel, Netherlands

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

Novartis Investigative Site

Groningen, , Netherlands

Site Status WITHDRAWN

Novartis Investigative Site

Bytom, , Poland

Site Status RECRUITING

Novartis Investigative Site

Lublin, , Poland

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Warsaw, , Poland

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Warsaw, , Poland

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Cape Town, Western Cape, South Africa

Site Status RECRUITING

Novartis Investigative Site

Cape Town, Western Cape, South Africa

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Sabadell, Barcelona, Spain

Site Status RECRUITING

Novartis Investigative Site

Bilbao, Bizkaia, Spain

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

A Coruña, , Spain

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Barcelona, , Spain

Site Status RECRUITING

Novartis Investigative Site

Madrid, , Spain

Site Status RECRUITING

Novartis Investigative Site

Seville, , Spain

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Valencia, , Spain

Site Status RECRUITING

Novartis Investigative Site

Basel, , Switzerland

Site Status WITHDRAWN

Novartis Investigative Site

Sankt Gallen, , Switzerland

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Barnet, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Hull, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Wolverhampton, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Belgium Brazil Canada Chile Colombia Czechia Denmark France Germany Hungary Israel Italy Japan Lebanon Mexico Netherlands Poland South Africa Spain Switzerland United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Novartis Pharmaceuticals

Role: CONTACT

Phone: 1-888-669-6682

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Olga Pimienta

Role: primary

Melyssa Godfrey

Role: primary

Cindy Valenzuela

Role: primary

Katie M Alvord

Role: primary

David O Dea

Role: primary

Danielle Dickey

Role: primary

Blair Walker

Role: primary

Jill Brooker

Role: primary

Denine Ryan

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-508077-85-00

Identifier Type: OTHER

Identifier Source: secondary_id

CAIN457C22301E1

Identifier Type: -

Identifier Source: org_study_id