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Polymyalgia RheumaticaPhase 3REPLENISHNCT05767034

Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)

A Phase 3 study testing Secukinumab 300 mg and Secukinumab 150 mg in people with Polymyalgia Rheumatica, run by Novartis Pharmaceuticals at 132 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed. 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 300 mg and Secukinumab 150 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
381 participants
Where
132 sitesin 26 countries
Study dates
22 Mar 2023to 16 Feb 2026
Phase
Phase 3
Are there results?
None posted in the registry

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

  • 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)
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

132 sites in 26 countries.

132 sites in 26 countries

United States22 sites

  • Arizona Arthritis and Rheumatology Associates PLLC

    Avondale, Arizona, 85392

  • Rheumatology Associates of South Florida

    Boca Raton, Florida, 33486

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • UF Health Cancer Center

    Gainesville, Florida, 32610

  • Southeastern Rheumatology Alliance

    Gainesville, Georgia, 30501

  • Klein and Associates

    Hagerstown, Maryland, 21740

  • Prolato Clinical Research Center

    Houston, Texas, 77054

  • DM Clinical Research

    Houston, Texas, 77070

  • Accurate Clinical Research Inc

    Houston, Texas, 77089

  • Kansas City Physician Partners

    Kansas City, Missouri, 64111

  • 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

  • AZ Arthritis and Rheumtlgy Rsh PLLC

    Phoenix, Arizona, 85032

  • Clinical Research Inst of MI

    Saint Clair Shores, Michigan, 48081

  • Precn Comprehensive Clnl Rsch Solns

    San Leandro, California, 94578

  • Providence Saint Johns Health Ctr

    Santa Monica, California, 90404

  • Sarasota Arthritis Res Ctr

    Sarasota, Florida, 34239

  • Advanced Rheumatology of Houston

    Spring, Texas, 77382

  • West Broward Rheumatology Associates Inc

    Tamarac, Florida, 33321

  • Center for Rheumatology Research

    West Hills, California, 91307

  • Millennium Clinical Trials

    Westlake Village, California, 91361

Other trials in United States

Japan17 sites

  • Novartis Investigative Site

    Asahikawa, Hokkaido, 0708644

  • Novartis Investigative Site

    Beppu, Oita Prefecture, 8740011

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 1138431

  • Novartis Investigative Site

    Chūō, Yamanashi, 409-3898

  • Novartis Investigative Site

    Fuchū, Tokyo, 1838524

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 8140180

  • Novartis Investigative Site

    Ichikawa, Chiba, 2728516

  • 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, 700-8607

  • Novartis Investigative Site

    Ōme, Tokyo, 198-0042

  • Novartis Investigative Site

    Osaka, Osaka, 550-0006

  • Novartis Investigative Site

    Osaka, 5340021

  • Novartis Investigative Site

    Sagamihara, Kanagawa, 2520392

  • Novartis Investigative Site

    Shimonoseki, Yamaguchi, 750-0041

  • Novartis Investigative Site

    Yokohama, Kanagawa, 222-0036

Other trials in Japan

France13 sites

  • Novartis Investigative Site

    Aix-en-Provence, 13616

  • 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

    Limoges, Haute Vienne, 87000

  • Novartis Investigative Site

    Montpellier, 34295

  • 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

Other trials in France

Germany9 sites

  • Novartis Investigative Site

    Berlin, 13125

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Dresden, Saxony, 01307

  • Novartis Investigative Site

    Erlangen, 91056

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Novartis Investigative Site

    Herne, 44649

  • Novartis Investigative Site

    Ratingen, 40878

  • Novartis Investigative Site

    Rendsburg, 24768

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080

Other trials in Germany

Czechia7 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

  • Novartis Investigative Site

    Zlín, 760 01

Other trials in Czechia

Italy7 sites

  • Novartis Investigative Site

    Bolzano, BZ, 39100

  • Novartis Investigative Site

    Milan, MI, 20100

  • Novartis Investigative Site

    Milan, MI, 20132

  • Novartis Investigative Site

    Milan, MI, 20157

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Perugia, PG, 06129

  • Novartis Investigative Site

    Reggio Emilia, RE, 42123

Other trials in Italy

Spain7 sites

  • Novartis Investigative Site

    A Coruña, 15006

  • Novartis Investigative Site

    Barcelona, 08041

  • 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

Other trials in Spain

Poland5 sites

  • Novartis Investigative Site

    Bytom, 41 902

  • Novartis Investigative Site

    Lublin, 20-607

  • Novartis Investigative Site

    Warsaw, 02-118

  • Novartis Investigative Site

    Warsaw, 02-637

  • Novartis Investigative Site

    Warsaw, 02-665

Other trials in Poland

Chile4 sites

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 7500571

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 8380465

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 8420383

  • Novartis Investigative Site

    Viña del Mar, Valparaiso, 2531172

Other trials in Chile

Colombia4 sites

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080002

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080020

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110221

  • Novartis Investigative Site

    Cali, Valle del Cauca Department, 760042

Other trials in Colombia

Denmark4 sites

  • Novartis Investigative Site

    Aarhus N, 8200

  • Novartis Investigative Site

    Esbjerg, 6700

  • Novartis Investigative Site

    Gandrup, 9362

  • Novartis Investigative Site

    Vejle, DK-7100

Other trials in Denmark

Argentina3 sites

  • Novartis Investigative Site

    Buenos Aires, C1055AAF

  • Novartis Investigative Site

    Caba, Buenos Aires, C1119ACN

  • Novartis Investigative Site

    Quilmes, Buenos Aires, B1878GEG

Other trials in Argentina

Australia3 sites

  • Novartis Investigative Site

    Heidelberg Heights, Victoria, 3081

  • Novartis Investigative Site

    Parramatta, New South Wales, 2150

  • Novartis Investigative Site

    Southport, Queensland, 4215

Other trials in Australia

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

Other trials in Brazil

Hungary3 sites

  • Novartis Investigative Site

    Budapest, 1027

  • Novartis Investigative Site

    Szeged, 6725

  • Novartis Investigative Site

    Veszprém, 8200

Other trials in Hungary

Netherlands3 sites

  • Novartis Investigative Site

    Almelo, Overijssel, 7609 PP

  • Novartis Investigative Site

    Groningen, 9713 GZ

  • Novartis Investigative Site

    Rotterdam, South Holland, 3079 DZ

Other trials in Netherlands

South Africa3 sites

  • Novartis Investigative Site

    Cape Town, Western Cape, 7405

  • Novartis Investigative Site

    Cape Town, Western Cape, 7500

  • Novartis Investigative Site

    Stellenbosch, Western Cape, 7600

Other trials in South Africa

Switzerland3 sites

  • Novartis Investigative Site

    Basel, 4031

  • Novartis Investigative Site

    Fribourg, 1708

  • Novartis Investigative Site

    Sankt Gallen, 9007

Other trials in Switzerland

United Kingdom3 sites

  • Novartis Investigative Site

    Barnet, EN5 3DJ

  • Novartis Investigative Site

    Hull, HU3 2RW

  • Novartis Investigative Site

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Belgium2 sites

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Liège, 4000

Other trials in Belgium

Israel2 sites

  • Novartis Investigative Site

    Ramat Gan, 5265601

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

Canada1 site

  • Novartis Investigative Site

    Québec, Quebec, G1V 3M7

Other trials in Canada

Ireland1 site

  • Novartis Investigative Site

    Dublin, D03 VX82

Other trials in Ireland

Lebanon1 site

  • Novartis Investigative Site

    Beirut, 1100 2070

Other trials in Lebanon

Mexico1 site

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44650

Other trials in Mexico

Sweden1 site

  • Novartis Investigative Site

    Stockholm, SE, 113 65

Other trials in Sweden

About this study

Official title: A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Evaluate Efficacy and Safety of Secukinumab Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)

The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in approximately 360 PMR patients who had recently relapsed. The study consists of: screening (up to 6 weeks); treatment period (52 weeks, with last IMP administration at 48 weeks, active drug or placebo) in combination with prednisone tapered over 24 weeks; treatment-free follow-up (up to 24 weeks). Adult males and females of at least 50 years of age with a recent PMR relapse (within 12 weeks from Baseline) will be included. Dosing will be once every week for the first 4 weeks, and once every 4 weeks thereafter via pre-filled syringe.

The primary objective is to demonstrate the efficacy of secukinumab 300 mg subcutaneously in combination with a 24-week glucocorticoid (GC) taper regimen compared with placebo with respect to the proportion of patients in sustained remission at Week 52. Primary secondary objectives are to assess difference in proportion of patients achieving complete sustained remission at Week 52, adjusted annual cumulative GC dose and time to first use of escape treatment or rescue treatment through Week 52. Key safety data will be collected, along with Patient Reported Outcomes.

Being tested
Secukinumab 300 mg, Secukinumab 150 mg, Placebo to secukinumab
Keywords
Polymyalgia Rheumatica, secukinumab, monoclonal antibody, prednisone taper regimen, glucocorticoid, PMR
Medical subject headings
Polymyalgia Rheumatica

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Secukinumab 300 mgDrug

    Also called AIN457

    Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen

  • Secukinumab 150 mgDrug

    Also called AIN457

    Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen

  • Placebo to secukinumabOther

    Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen

Study groups in NCT05767034
Study groupRoleWhat they receive
Secukinumab 300 mgExperimentalrandomized in 1:1:1 ratio every 4 weeks
Receives: Drug: Secukinumab 300 mg
Secukinumab 150 mgExperimentalrandomized in 1:1:1 ratio every 4 weeks
Receives: Drug: Secukinumab 150 mg
Placebo to secukinumabPlacebo comparatorrandomized in 1:1:1 ratio every 4 weeks
Receives: Other: Placebo to secukinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants achieving sustained remission

    Sustained remission at Week 52 is defined as a participant meeting all of the following:

    ● achieved remission at Week 12

    AND all of the following, sustained from Week 12 to Week 52:

    • no recurrence of signs or symptoms, attributable to PMR, that requires escape treatment or rescue treatment
    • no new diagnosis of Giant cell arteritis (GCA), that requires escape treatment or rescue treatment

    Remission at Week 12 is defined as a participant meeting all of the following at Week 12:

    • no use of escape treatment or rescue treatment prior to Week 12
    • no signs or symptoms attributable to PMR, that requires escape treatment or use of rescue treatment, at Week 12
    • no new diagnosis of GCA, that requires escape treatment or rescue treatment, at Week 12

    Measured: at Week 52

Secondary outcomes (5)

  1. Proportion of patients achieving complete sustained remission

    Complete sustained remission at Week 52 is defined as participant meeting all of the following:

    • achieved sustained remission
    • no clinically relevant elevation of Erythrocyte sedimentation Rate (ESR) and/or C-reactive protein (CRP) at ≥2 consecutive scheduled visits from Week 12 to Week 52

    Measured: 52 Weeks

  2. Adjusted annual cumulative glucocorticoid (GC) dose adjusted by duration of study follow-up

    Adjusted annual cumulative GC dose is cumulative GC dose through Week 52 adjusted by duration of study follow-up

    Measured: 52 Weeks

  3. Time to first use of escape treatment or rescue treatment as measured in days

    First use of escape treatment or rescue treatment is defined as the first time when the escape treatment or rescue treatment is used

    Measured: 52 Weeks

  4. Change in FACIT-Fatigue Score

    The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function.

    The purpose of collecting available FACIT-Fatigue data is to assess the impact of fatigue on participants with PMR.

    Measured: 52 Weeks

  5. Change in HAQ-DI score

    The Health Assessment Questionnaire - Disability Index (HAQ-DI) is used to assess the long-term influence of chronic disease on a participant's level of functional ability and activity restriction. The purpose of the HAQ-DI is to assess the functional ability of subjects with PMR.

    Measured: 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2023
  2. Study start22 Mar 2023
  3. Primary completion10 Sep 2025
  4. Study completion16 Feb 2026

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
381 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05767034
Sponsor's protocol ID
CAIN457C22301
Other IDs
2022-501895-25-00
Acronym
REPLENISH
Status last verified
Jun 2026
First submitted
6 Mar 2023
Last updated
22 Jun 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

Publications

  • Stone JH, Buttgereit F, Saraux A, Schmidt WA, Dejaco C, Spiera R, Dasgupta B, Drescher E, Jordan A, Novosad L, Nakagomi D, Koyama Y, Duran-Barragan S, Tracey G, Ruyssen-Witrand A, Rubbert Roth A, Fang J, Ng J, Hiremath R, Raffner R, Martin R, Napoletano S, Huang S, Storim J, Patekar M; REPLENISH Investigators. Phase 3 Trial of Secukinumab in Polymyalgia Rheumatica. N Engl J Med. 2026 Jun 3. doi: 10.1056/NEJMoa2602567. Online ahead of print.

    PubMed 42234540

  • Sun MM, Pope JE. Polymyalgia rheumatica and giant cell arteritis: diagnosis and management. Curr Opin Rheumatol. 2025 Jan 1;37(1):32-38. doi: 10.1097/BOR.0000000000001059. Epub 2024 Oct 14.

    PubMed 39400109

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Secukinumab 300 mg and Secukinumab 150 mg in people with Polymyalgia Rheumatica, run by Novartis Pharmaceuticals at 132 sites in 26 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 12 inclusion and 6 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: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in United States, Japan, France, Germany, Czechia and 21 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of participants achieving sustained remission (time frame: at Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05767034, which also lists 2 linked publications.

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 22 Jun 2026.

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