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New hope for PMR patients: Long-Term safety trial of secukinumab underway

NCT ID NCT06331312

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study is testing the long-term safety of secukinumab, a biologic drug, in people with polymyalgia rheumatica (PMR). It includes 161 patients who already completed a 52-week study of secukinumab and had a relapse after stopping treatment. The main goal is to see how safe and tolerable the drug is over an extended period.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
secukinumab (a biologic drug given as an injection under the skin)
What this could lead to
If successful, this could show that secukinumab is a safe long-term treatment option for managing polymyalgia rheumatica, reducing the need for steroids.
What could go wrong
This is an extension study focused on safety, not on proving how well the drug works. The results may not apply to all patients, and long-term use of biologics carries risks like infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

162 people

The number who actually took part.

Started

Jun 2024

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

polymyalgia rheumatica

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Polymyalgia rheumatica

Contacts and locations

Locations

  • Accurate Clinical Research Inc

    Houston, Texas, 77089, United States

  • Advanced Rheumatology of Houston

    The Woodlands, Texas, 77382, United States

  • Arizona Arthritis and Rheumatology Associates PLLC

    Avondale, Arizona, 85392, United States

  • Center for Rheumatology Research

    Woodland Hills, California, 91364, United States

  • Clinical Research Inst of MI

    Saint Clair Shores, Michigan, 48081, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Klein and Associates

    Hagerstown, Maryland, 21740, United States

  • Millennium Clinical Trials

    Westlake Village, California, 91361, United States

  • Novartis Investigative Site

    Quilmes, Buenos Aires, B1878GEG, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1055AAF, Argentina

  • Novartis Investigative Site

    Parramatta, New South Wales, 2150, Australia

  • Novartis Investigative Site

    Heidelberg Heights, Victoria, 3081, Australia

  • Novartis Investigative Site

    Liège, 4000, Belgium

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 04038-002, Brazil

  • Novartis Investigative Site

    São Paulo, 01409-902, Brazil

  • Novartis Investigative Site

    Québec, Quebec, G1V 3M7, Canada

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 7500571, Chile

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 8420383, Chile

  • Novartis Investigative Site

    Viña del Mar, Valparaiso, 2531172, Chile

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110221, Colombia

  • Novartis Investigative Site

    Prague, Czech Republic, 140 00, Czechia

  • Novartis Investigative Site

    Brno, 638 00, Czechia

  • Novartis Investigative Site

    Hlučín, 748 01, Czechia

  • Novartis Investigative Site

    Prague, 128 00, Czechia

  • Novartis Investigative Site

    Prague, 140 00, Czechia

  • Novartis Investigative Site

    Uherské Hradiště, 686 01, Czechia

  • Novartis Investigative Site

    Esbjerg, 6700, Denmark

  • Novartis Investigative Site

    Gandrup, 9362, Denmark

  • Novartis Investigative Site

    Vejle, 7100, Denmark

  • Novartis Investigative Site

    Toulon, Val De Marne, 83800, France

  • Novartis Investigative Site

    Brest, 29200, France

  • Novartis Investigative Site

    Cholet, 49325, France

  • Novartis Investigative Site

    Colmar, 68024, France

  • Novartis Investigative Site

    Dijon, 21000, France

  • Novartis Investigative Site

    Le Mans, 72000, France

  • Novartis Investigative Site

    Nantes, 44093, France

  • Novartis Investigative Site

    Reims, 51092, France

  • Novartis Investigative Site

    Strasbourg, 67000, France

  • Novartis Investigative Site

    Toulouse, 31059, France

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080, Germany

  • Novartis Investigative Site

    Berlin, 13125, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Herne, 44649, Germany

  • Novartis Investigative Site

    Budapest, 1027, Hungary

  • Novartis Investigative Site

    Szeged, 6725, Hungary

  • Novartis Investigative Site

    Veszprém, 8200, Hungary

  • Novartis Investigative Site

    Milan, MI, 20100, Italy

  • Novartis Investigative Site

    Perugia, PG, 06129, Italy

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 8140180, Japan

  • Novartis Investigative Site

    Asahikawa, Hokkaido, 0708644, Japan

  • Novartis Investigative Site

    Kita-gun, Kagawa-ken, 7610793, Japan

  • Novartis Investigative Site

    Sagamihara, Kanagawa, 2520392, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 222-0036, Japan

  • Novartis Investigative Site

    Nagano, Nagano, 3808582, Japan

  • Novartis Investigative Site

    Kawachi-Nagano, Osaka, 5868521, Japan

  • Novartis Investigative Site

    Osaka, Osaka, 5340021, Japan

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 1138431, Japan

  • Novartis Investigative Site

    Fuchū, Tokyo, 1838524, Japan

  • Novartis Investigative Site

    Ōme, Tokyo, 198-0042, Japan

  • Novartis Investigative Site

    Chūō, Yamanashi, 409-3898, Japan

  • Novartis Investigative Site

    Okayama, 700-8607, Japan

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44650, Mexico

  • Novartis Investigative Site

    Almelo, Overijssel, 7609 PP, Netherlands

  • Novartis Investigative Site

    Rotterdam, South Holland, 3079 DZ, Netherlands

  • Novartis Investigative Site

    Lublin, 20-607, Poland

  • Novartis Investigative Site

    Warsaw, 02-118, Poland

  • Novartis Investigative Site

    Warsaw, 02-665, Poland

  • Novartis Investigative Site

    Cape Town, Western Cape, 7405, South Africa

  • Novartis Investigative Site

    Cape Town, Western Cape, 7500, South Africa

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208, Spain

  • Novartis Investigative Site

    Bilbao, Bizkaia, 48013, Spain

  • Novartis Investigative Site

    A Coruña, 15006, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Seville, 41013, Spain

  • Novartis Investigative Site

    Valencia, 46010, Spain

  • Novartis Investigative Site

    Sankt Gallen, 9007, Switzerland

  • Novartis Investigative Site

    Barnet, EN5 3DJ, United Kingdom

  • Novartis Investigative Site

    Wolverhampton, WV10 0QP, United Kingdom

  • Paramount Med Rsrch and Consult LLC

    Middleburg Heights, Ohio, 44130, United States

  • Prolato Clinical Research Center

    Houston, Texas, 77054, United States

  • Rheumatology Associates of South Florida

    Boca Raton, Florida, 33486, United States

  • Sun Valley Arthritis Center Ltd

    Peoria, Arizona, 85381, United States

  • West Broward Rheumatology Associates Inc

    Tamarac, Florida, 33321, United States

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Other studies related to the condition(s) this trial covers.