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Polymyalgia RheumaticaPhase 2AIM-PMRNCT04972968

A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154

A Phase 2 study testing ABBV-154 and Glucocorticoid in people with Polymyalgia Rheumatica, run by AbbVie at 117 sites in 15 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older. This study evaluates how safe and effective ABBV-154 is in participants with glucocorticoid-dependent PMR. Adverse events and change in disease activity will be assessed. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Polymyalgia Rheumatica
What is being tested?
ABBV-154 and Glucocorticoid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
181 participants
Where
117 sitesin 15 countries
Study dates
9 Sep 2021to 24 Jul 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of Polymyalgia Rheumatica (PMR) and fulfillment of the 2012 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) provisional classification criteria for PMR.
  • Must have had at least 2 episodes of unequivocal PMR flare.
  • Must be on a stable dose of prednisone.
  • Must be willing to follow the protocol-defined glucocorticoid tapering regimen.

Who cannot join

  • Have been treated with a prior TNF antagonist.
  • Current use of immunomodulators other than prednisone and hydroxychloroquine.

Trial locations and contacts

117 sites in 15 countries.

117 sites in 15 countries

United States31 sites

  • Arthritis & Rheumatic Disease Specialties /ID# 245448

    Aventura, Florida, 33180

  • Rheumatology Care Center PLLC /ID# 232306

    Bellaire, Texas, 77401-2900

  • Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 232238

    Boca Raton, Florida, 33486

  • International Medical Research /ID# 228765

    Daytona Beach, Florida, 32117

  • Omega Research Debary, LLC /ID# 245450

    DeBary, Florida, 32713-2260

  • Denver Arthritis Clinic /ID# 245736

    Denver, Colorado, 80230

  • Altoona Ctr Clinical Res /ID# 232493

    Duncansville, Pennsylvania, 16635

  • Providence Medical Foundation /ID# 228681

    Fullerton, California, 92835

  • Care Access Research, Huntington Beach /ID# 228677

    Huntington Beach, California, 92648

  • West Tennessee Research Institute /ID# 228854

    Jackson, Tennessee, 38305

  • Arthritis and Rheumatism Associates /ID# 232089

    Jonesboro, Arkansas, 72401-6251

  • Purushotham & Akther Kotha MD, Inc /ID# 245391

    La Mesa, California, 91942

  • Arthritis & Osteo Medical Ctr /ID# 228680

    La Palma, California, 90623-1728

  • Dartmouth-Hitchcock Medical Center /ID# 229557

    Lebanon, New Hampshire, 03756

  • Delaware Arthritis /ID# 230110

    Lewes, Delaware, 19958

  • Lakes Research, LLC /ID# 228757

    Miami, Florida, 33014

  • Paramount Medical Research Con /ID# 228839

    Middleburg Heights, Ohio, 44130

  • Hospital for Special Surgery /ID# 228577

    New York, New York, 10021

  • HMD Research LLC /ID# 228767

    Orlando, Florida, 32819

  • Four Rivers Clinical Research /ID# 228858

    Paducah, Kentucky, 42001

  • Clinical Research Source, Inc. /ID# 231903

    Perrysburg, Ohio, 43551

  • St. Lawrence Health System /ID# 229702

    Potsdam, New York, 13676

  • University of Rochester Medical Center /ID# 232554

    Rochester, New York, 14642

  • Hans Richard Barthel, M.D., Inc /ID# 231902

    Santa Barbara, California, 93108

  • Springfield Clinic /ID# 228840

    Springfield, Illinois, 62702-3749

  • Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 228860

    Summerville, South Carolina, 29486-7887

  • DM Clinical Research - Tomball /ID# 245512

    Tomball, Texas, 77375

  • Ocean Rheumatology, PA /ID# 232539

    Toms River, New Jersey, 08755

  • Medvin Clinical Research /ID# 228675

    Tujunga, California, 91042-2706

  • Rheumatology Consultants - Clinical Research /ID# 232137

    Tupelo, Mississippi, 38801-4949

  • Inland Rheum & Osteo Med Grp /ID# 228679

    Upland, California, 91786

Other trials in United States

Japan12 sites

  • Kyushu University Beppu Hospital /ID# 232250

    Beppu-shi, Oita Prefecture, 874-0838

  • Tokyo Medical And Dental University Hospital /ID# 232206

    Bunkyo-ku, Tokyo, 113-8519

  • Rinku Hashimoto Rheumatology Orthopaedics /ID# 246532

    Izumisano, Osaka, 598-0048

  • Kuwana city medical center /ID# 231936

    Kuwana-shi, Mie-ken, 511-0061

  • Matsuyama Red Cross Hospital /ID# 230458

    Matsuyama, Ehime, 790-8524

  • Daido Clinic /ID# 230204

    Nagoya, Aichi-ken, 457-8511

  • NHO Nagoya Medical Center /ID# 232420

    Nagoya, Aichi-ken, 460-0001

  • Japanese Red Cross Okayama Hospital /ID# 230857

    Okayama, Okayama-ken, 700-8607

  • Sanuki Municipal Hospital /ID# 230202

    Sanuki-shi, Kagawa-ken, 769-2393

  • Osaka Medical and Pharmaceutical University Hospital /ID# 246530

    Takatsuki-shi, Osaka, 569-8686

  • Toyama Prefectural Central Hospital /ID# 230616

    Toyama, Toyama, 930-8550

  • National Hospital Organization Shimoshizu National Hospital /ID# 230500

    Yotsukaido-shi, Chiba, 284-0003

Other trials in Japan

Hungary9 sites

  • Clinexpert Kft /ID# 229677

    Budapest, 1033

  • Obudai Egeszsegugyi Centrum Kft. /ID# 231121

    Budapest, 1036

  • Debreceni Egyetem Klinikai Kozpont /ID# 241674

    Debrecen, Hajdú-Bihar, 4032

  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 229758

    Gyula, 5700

  • Kistarcsai Flor Ferenc Korhaz /ID# 229676

    Kistarcsa, 2143

  • CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 230065

    Székesfehérvár, 8000

  • Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz /ID# 229793

    Szentes, 6600

  • Vital Medical Center Orvosi es Fogaszati Kozpont (Vital Medicina Kft.) /ID# 229674

    Veszprém, 8200

  • Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 229759

    Zalaegerszeg, Zala County, 8900

Other trials in Hungary

United Kingdom9 sites

  • North West Anglia NHS Foundation Trust /ID# 230866

    Bretton, Cambridgeshire, PE3 9GZ

  • Cardiff & Vale University Health Board /ID# 245297

    Cardiff, Wales, CF14 4XN

  • UH Coventry & Warwickshire /ID# 228588

    Coventry, CV2 2DX

  • NHS Lothian /ID# 245293

    Edinburgh, EH3 9HE

  • Leicester Royal Infirmary /ID# 231967

    Leicester, England, LE1 5WW

  • Liverpool University Hospitals NHS Foundation Trust /ID# 245296

    Liverpool, L7 8XP

  • The Royal Free London NHS Foundation Trust /ID# 231707

    London, London, City of, NW3 2QG

  • Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 231966

    Norwich, Norfolk, NR4 7UY

  • Portsmouth Hospitals University NHS Trust /ID# 245291

    Portsmouth, PO6 3LY

Other trials in United Kingdom

Australia8 sites

  • Emeritus Research Sydney /ID# 229166

    Botany, New South Wales, 2019

  • Emeritus Research /ID# 229270

    Camberwell, Victoria, 3124

  • Royal Prince Alfred Hospital /ID# 244888

    Camperdown, New South Wales, 2050

  • Austin Health /ID# 229164

    Heidelberg, Victoria, 3084

  • Fiona Stanley Hospital /ID# 229050

    Murdoch, Western Australia, 6150

  • BJC Health /ID# 244839

    Parramatta, New South Wales, 2150

  • Tasman Health Care /ID# 230829

    Southport, Queensland, 4215

  • The Queen Elizabeth Hospital /ID# 229049

    Woodville South, South Australia, 5011

Other trials in Australia

Spain7 sites

  • Hospital Clinic de Barcelona /ID# 229295

    Barcelona, 08036

  • Hospital General Universitario Gregorio Maranon /ID# 229302

    Madrid, 28007

  • Hospital Clinico Universitario San Carlos /ID# 229296

    Madrid, 28040

  • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 244866

    Sabadell, Barcelona, 08208

  • Hospital Universitario Canarias /ID# 229451

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • Hospital Universitario Marques de Valdecilla /ID# 229297

    Santander, Cantabria, 39008

  • Hospital Clínico Universitario de Santiago-CHUS /ID# 244868

    Santiago de Compostela, A Coruna, 15706

Other trials in Spain

France6 sites

  • CHU de Besancon - Jean Minjoz /ID# 244897

    Besançon, Doubs, 25030

  • Hopital de la Cavale Blanche /ID# 228348

    Brest, Finistere, 29200

  • CHRU Tours - Hopital Trousseau /ID# 228349

    Chambray-lès-Tours, 37170

  • Centre Hospitalier du Mans /ID# 229044

    Le Mans, Sarthe, 72037

  • CHU Montpellier - Hôpital Lapeyronie /ID# 228347

    Montpellier, Herault, 34090

  • AP-HP - Hopital Cochin /ID# 231800

    Paris, 75014

Other trials in France

Italy6 sites

  • ASL 3 Genovese - Ospedale la Colletta /ID# 229282

    Arenzano, Genova, 16011

  • Azienda Ospedaliero-Universitaria di Modena /ID# 228825

    Modena, 41124

  • Fondazione IRCCS Policlinico /ID# 245274

    Pavia, 27100

  • Azienda Ospedaliero-Universitaria Senese-Ospedale Santa Maria delle Scotte /ID# 245273

    Siena, 53100

  • A.O.U. Citta della Salute e della Scienza di Torino /ID# 229080

    Turin, Torino, 10126

  • Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 228815

    Udine, 33100

Other trials in Italy

New Zealand6 sites

  • CGM Research Trust /ID# 244893

    Christchurch Central, 8011

  • Optimal Clinical Trials Ltd /ID# 229048

    Grafotn, Auckland, 1010

  • Waikato Hospital /ID# 229047

    Hamilton, Waikato Region, 3240

  • Wellington Regional Hospital /ID# 229490

    Newtown, Wellington Region, 6021

  • Aotearoa Clinical Trials /ID# 229099

    Papatoetoe, Auckland, 2025

  • Timaru Medical Specialists Ltd /ID# 229098

    Timaru, Canterbury, 7910

Other trials in New Zealand

Poland6 sites

  • Nova Reuma Domyslawska I Rusilowicz - Spolka Partnerska Lekarza Reumatologa I Fi /Id# 228466

    Bialystok, Podlaskie Voivodeship, 15-707

  • Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 228353

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • AI Centrum Medyczne Sp. z o.o. sp.k. /ID# 228951

    Poznan, Greater Poland Voivodeship, 61-113

  • Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 228314

    Poznan, Greater Poland Voivodeship, 61-545

  • Centrum Medyczne Reuma Park /ID# 244813

    Warsaw, Masovian Voivodeship, 02-665

  • Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o /ID# 228357

    Wroclaw, Lower Silesian Voivodeship, 53-224

Other trials in Poland

Germany5 sites

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 228661

    Berlin, 10117

  • Immanuel Krankenhaus Berlin /ID# 228659

    Buch, 13125

  • MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 228658

    Hamburg, 20095

  • Medius Klinik Kirchheim /ID# 228660

    Kirchheim unter Teck, Baden-Wurttemberg, 73230

  • Rheumazentrum Ratingen /ID# 245183

    Ratingen, 40882

Other trials in Germany

Netherlands5 sites

  • ZiekenhuisGroep Twente /ID# 229071

    Almelo, 7609 PP

  • Universitair Medisch Centrum Groningen /ID# 227727

    Groningen, 9713 GZ

  • Medisch Centrum Leeuwarden /ID# 245442

    Leeuwarden, 8934 AD

  • Maastricht Universitair Medisch Centrum /ID# 227779

    Maastricht, 6229 HX

  • Maasstad Ziekenhuis /ID# 228064

    Rotterdam, 3079 DZ

Other trials in Netherlands

Canada4 sites

  • The Waterside Clinic /ID# 230364

    Barrie, Ontario, L4M 6L2

  • Rheumatology Research Associates /ID# 230363

    Edmonton, Alberta, T5M 0H4

  • CISSSBSL -Hopital regional de Rimouski /ID# 228394

    Rimouski, Quebec, G5L 5T1

  • Centre de Recherche Musculo-Squelettique /ID# 228392

    Trois-Rivières, Quebec, G8Z 1Y2

Other trials in Canada

South Korea2 sites

  • Kyungpook National University Hospital /ID# 228716

    Daegu, 41944

  • Hanyang University Seoul Hospital /ID# 228719

    Seoul, Seoul Teugbyeolsi, 04763

Other trials in South Korea

Austria1 site

  • Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 229436

    Vienna, State of Vienna, 1100

Other trials in Austria

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment

Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older. This study evaluates how safe and effective ABBV-154 is in participants with glucocorticoid-dependent PMR. Adverse events and change in disease activity will be assessed.

ABBV-154 is an investigational drug being evaluated for the treatment of PMR. Participants will be randomized into 1 of 4 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 participants, of at least 50 years of age, with PMR will be enrolled in the study at approximately 95 sites worldwide.

Read more

The study is compromised of a 52 week double-blind, placebo-controlled period and a follow-up visit 70 days after the last dose of the study drug. All participants will receive a glucocorticoid taper along with the assigned dose of ABBV-154 or placebo, subcutaneously (SC) every other week (eow).

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Being tested
ABBV-154, Placebo, Glucocorticoid
Keywords
Polymyalgia Rheumatica, PMR, ABBV-154, Glucocorticoid
Medical subject headings
Polymyalgia Rheumatica

What participants receive

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

  • ABBV-154Drug

    Subcutaneous Injection

  • PlaceboDrug

    Subcutaneous Injection

  • GlucocorticoidDrug

    Oral Tablet

Study groups in NCT04972968
Study groupRoleWhat they receive
ABBV-154 Dose AExperimentalParticipants in this group will receive dose A of ABBV-154 subcutaneously (SC) every other week (eow) for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Receives: Drug: ABBV-154; Drug: Glucocorticoid
ABBV-154 Dose BExperimentalParticipants in this group will receive dose B of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Receives: Drug: ABBV-154; Drug: Glucocorticoid
ABBV-154 Dose CExperimentalParticipants in this group will receive dose C of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Receives: Drug: ABBV-154; Drug: Glucocorticoid
PlaceboPlacebo comparatorParticipants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Receives: Drug: Placebo; Drug: Glucocorticoid

What is being measured

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

  1. Time to Flare

    Flare is defined as, presence of clinical signs and symptoms of PMR and requirement to increase the glucocorticoid dose per investigator.

    Measured: From first dose of study drug to Week 52

Secondary outcomes (3)

  1. Percentage of Participants Achieving Flare-Free State

    Percentage of participants achieving flare-free state.

    Measured: Up to Week 24

  2. Cumulative Glucocorticoid Dose

    Cumulative glucocorticoid dose.

    Measured: Week 24

  3. Change From Baseline in Glucocorticoid Dose

    Change from Baseline in glucocorticoid dose.

    Measured: Week 24

Timeline

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

  1. First posted22 Jul 2021
  2. Study start9 Sep 2021
  3. Primary completion24 Jul 2023
  4. Study completion24 Jul 2023

Why it stopped: Strategic considerations

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04972968
Sponsor's protocol ID
M20-370
Other IDs
2021-000648-23
Acronym
AIM-PMR
Status last verified
Oct 2024
First submitted
13 Jul 2021
Last updated
15 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABBV-154 and Glucocorticoid in people with Polymyalgia Rheumatica, run by AbbVie at 117 sites in 15 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, Japan, Hungary, United Kingdom, Australia and 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to Flare (time frame: From first dose of study drug to 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 NCT04972968.

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 15 Oct 2024.

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