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New hope for PMR patients: drug may replace long-term steroids

NCT ID NCT05767034

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

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested two doses of secukinumab (a shot) combined with a steroid taper in 381 adults aged 50+ with polymyalgia rheumatica (PMR) who had recently relapsed. The goal was to see if secukinumab helps patients achieve and maintain remission without needing steroids long-term. PMR causes severe pain and stiffness, and current treatment relies on steroids that have serious side effects.

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

381 people

The number who actually took part.

Started

Mar 2023

Finished

Feb 2026

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: * Signed informed consent must be obtained prior to participation in the study * Male or non-pregnant, non-lactating female participants at least 50 years of age. * Diagnosis of PMR according to the provisional American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria: Participants ≥ 50 years of age with a history of bilateral shoulder pain accompanied by elevated C-reactive protein (CRP) concentration (≥ 10 mg/L) and/or elevated erythrocyte sedimentation rate (ESR) (≥ 30 mm/hr) who scored at least 4 points from the following optional classification criteria: * Morning stiffness \> 45 minutes (min) (2 points) * Hip pain or restricted range of motion (1 point) * Absence of rheumatoid factor and/or anti-citrullinated protein antibodies (2 points) * Absence of other joint involvement (1 point) * Participants must have a history of being treated for at least 8 consecutive weeks with prednisone ≥ 10 mg/day, or equivalent dose of another GC at any time prior to screening * Participants must have had at least one episode of PMR relapse while attempting to taper prednisone at a dose that is ≥ 5 mg/day (or equivalent dose of another GC) within the past 12 weeks prior to BSL. Diagnosis of a PMR relapse is defined as participant meeting both of the following: * Recurrence of bilateral shoulder girdle and/or bilateral hip girdle pain associated with inflammatory stiffness with or without additional symptoms indicative of PMR relapse (such as constitutional symptoms) within 12 weeks prior to BSL that are in the opinion of the Investigator not due to other diseases that may mimic PMR such as osteoarthritis in shoulders or hips, polyarticular calcium pyrophosphate deposition disease, rotator cuff disease, adhesive capsulitis (frozen shoulder) or fibromyalgia. * Elevated ESR (≥ 30 mm/hr) and/or elevated CRP (\> upper limit of normal (ULN)) attributable to PMR at the time of relapse and/or at screening * Participants must have been treated as per local treatment recommendations following the latest PMR relapse and must be on prednisone of at least 7.5 mg/day (or equivalent) and not exceeding 25 mg/day at screening and during the screening period Exclusion Criteria: * Evidence/history of GCA as indicated by typical (cranial) symptoms (e.g., persistent or recurrent localized headache, temporal artery or scalp tenderness, jaw claudication, blurry or loss of vision, symptoms of stroke), extremity claudication, imaging and/or temporal artery biopsy result * Concurrent rheumatoid arthritis or other inflammatory arthritis or other connective tissue diseases, such as but not limited to systemic lupus erythematosus, systemic sclerosis, vasculitis, myositis, mixed connective tissue disease, and ankylosing spondylitis * Concurrent diagnosis or history of neuropathic muscular diseases or fibromyalgia * Inadequately treated hypothyroidism (e.g., persistence of symptoms, lack of normalization of serum TSH despite regular hormonal replacement treatment) * Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor * Participants treated with tocilizumab or other IL-6/IL6-receptor inhibitors within 12 weeks or within 5 half-lives (whichever is longer) prior to BSL; participant who did not respond to or experienced a relapse during treatment are excluded from enrollment into the study Other protocol-defined inclusion/exclusion criteria may apply

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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

  • AZ Arthritis and Rheumtlgy Rsh PLLC

    Phoenix, Arizona, 85032, United States

  • Accurate Clinical Research Inc

    Houston, Texas, 77089, United States

  • Advanced Rheumatology of Houston

    Spring, Texas, 77382, United States

  • Arizona Arthritis and Rheumatology Associates PLLC

    Avondale, Arizona, 85392, United States

  • Center for Rheumatology Research

    West Hills, California, 91307, United States

  • Clinical Research Inst of MI

    Saint Clair Shores, Michigan, 48081, United States

  • DM Clinical Research

    Houston, Texas, 77070, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Kansas City Physician Partners

    Kansas City, Missouri, 64111, United States

  • Klein and Associates

    Hagerstown, Maryland, 21740, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Millennium Clinical Trials

    Westlake Village, California, 91361, United States

  • Novartis Investigative Site

    Caba, Buenos Aires, C1119ACN, Argentina

  • 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

    Southport, Queensland, 4215, Australia

  • Novartis Investigative Site

    Heidelberg Heights, Victoria, 3081, Australia

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • 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, 8380465, Chile

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 8420383, Chile

  • Novartis Investigative Site

    Viña del Mar, Valparaiso, 2531172, Chile

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080002, Colombia

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080020, Colombia

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110221, Colombia

  • Novartis Investigative Site

    Cali, Valle del Cauca Department, 760042, 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

    Zlín, 760 01, Czechia

  • Novartis Investigative Site

    Aarhus N, 8200, Denmark

  • Novartis Investigative Site

    Esbjerg, 6700, Denmark

  • Novartis Investigative Site

    Gandrup, 9362, Denmark

  • Novartis Investigative Site

    Vejle, DK-7100, Denmark

  • Novartis Investigative Site

    Limoges, Haute Vienne, 87000, France

  • Novartis Investigative Site

    Toulon, Val De Marne, 83800, France

  • Novartis Investigative Site

    Aix-en-Provence, 13616, 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

    Montpellier, 34295, 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

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Berlin, 13125, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Erlangen, 91056, Germany

  • Novartis Investigative Site

    Herne, 44649, Germany

  • Novartis Investigative Site

    Ratingen, 40878, Germany

  • Novartis Investigative Site

    Rendsburg, 24768, Germany

  • Novartis Investigative Site

    Budapest, 1027, Hungary

  • Novartis Investigative Site

    Szeged, 6725, Hungary

  • Novartis Investigative Site

    Veszprém, 8200, Hungary

  • Novartis Investigative Site

    Dublin, D03 VX82, Ireland

  • Novartis Investigative Site

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    Bolzano, BZ, 39100, Italy

  • Novartis Investigative Site

    Milan, MI, 20100, Italy

  • Novartis Investigative Site

    Milan, MI, 20132, Italy

  • Novartis Investigative Site

    Milan, MI, 20157, Italy

  • Novartis Investigative Site

    Perugia, PG, 06129, Italy

  • Novartis Investigative Site

    Pavia, PV, 27100, Italy

  • Novartis Investigative Site

    Reggio Emilia, RE, 42123, Italy

  • Novartis Investigative Site

    Ichikawa, Chiba, 2728516, Japan

  • 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

    Beppu, Oita Prefecture, 8740011, Japan

  • Novartis Investigative Site

    Kawachi-Nagano, Osaka, 5868521, Japan

  • Novartis Investigative Site

    Osaka, Osaka, 550-0006, 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

    Shimonoseki, Yamaguchi, 750-0041, Japan

  • Novartis Investigative Site

    Chūō, Yamanashi, 409-3898, Japan

  • Novartis Investigative Site

    Okayama, 700-8607, Japan

  • Novartis Investigative Site

    Osaka, 5340021, Japan

  • Novartis Investigative Site

    Beirut, 1100 2070, Lebanon

  • 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

    Groningen, 9713 GZ, Netherlands

  • Novartis Investigative Site

    Bytom, 41 902, Poland

  • Novartis Investigative Site

    Lublin, 20-607, Poland

  • Novartis Investigative Site

    Warsaw, 02-118, Poland

  • Novartis Investigative Site

    Warsaw, 02-637, 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

    Stellenbosch, Western Cape, 7600, 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

    Barcelona, 08041, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Seville, 41013, Spain

  • Novartis Investigative Site

    Valencia, 46010, Spain

  • Novartis Investigative Site

    Stockholm, SE, 113 65, Sweden

  • Novartis Investigative Site

    Basel, 4031, Switzerland

  • Novartis Investigative Site

    Fribourg, 1708, Switzerland

  • Novartis Investigative Site

    Sankt Gallen, 9007, Switzerland

  • Novartis Investigative Site

    Barnet, EN5 3DJ, United Kingdom

  • Novartis Investigative Site

    Hull, HU3 2RW, United Kingdom

  • Novartis Investigative Site

    Wolverhampton, WV10 0QP, United Kingdom

  • Paramount Med Rsrch and Consult LLC

    Middleburg Heights, Ohio, 44130, United States

  • Precn Comprehensive Clnl Rsch Solns

    San Leandro, California, 94578, United States

  • Prolato Clinical Research Center

    Houston, Texas, 77054, United States

  • Providence Saint Johns Health Ctr

    Santa Monica, California, 90404, United States

  • Rheumatology Associates of South Florida

    Boca Raton, Florida, 33486, United States

  • Sarasota Arthritis Res Ctr

    Sarasota, Florida, 34239, United States

  • Southeastern Rheumatology Alliance

    Gainesville, Georgia, 30501, United States

  • Sun Valley Arthritis Center Ltd

    Peoria, Arizona, 85381, United States

  • UF Health Cancer Center

    Gainesville, Florida, 32610, United States

  • West Broward Rheumatology Associates Inc

    Tamarac, Florida, 33321, United States

More trials for these conditions

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