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 (AIM-PMR)

October 10, 2024 updated by: AbbVie

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

181

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Emeritus Research Sydney /ID# 229166
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital /ID# 244888
      • Paramatta, New South Wales, Australia, 2150
        • BJC Health /ID# 244839
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Tasman Health Care /ID# 230829
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital /ID# 229049
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research /ID# 229270
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health /ID# 229164
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital /ID# 229050
  • Austria
    • Wien
      • Vienna, Wien, Austria, 1100
        • Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 229436
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5M 0H4
        • Rheumatology Research Associates /ID# 230363
    • Ontario
      • Barrie, Ontario, Canada, L4M 6L2
        • The Waterside Clinic /ID# 230364
    • Quebec
      • Rimouski, Quebec, Canada, G5L 5T1
        • CISSSBSL -Hopital regional de Rimouski /ID# 228394
      • Trois-rivières, Quebec, Canada, G8Z 1Y2
        • Centre de Recherche Musculo-Squelettique /ID# 228392
  • France
      • Chambray Les Tours, France, 37170
        • CHRU Tours - Hopital Trousseau /ID# 228349
      • Paris, France, 75014
        • AP-HP - Hopital Cochin /ID# 231800
    • Doubs
      • Besancon, Doubs, France, 25030
        • CHU de Besancon - Jean Minjoz /ID# 244897
    • Finistere
      • Brest, Finistere, France, 29200
        • Hopital de la Cavale Blanche /ID# 228348
    • Herault
      • Montpellier, Herault, France, 34090
        • CHU Montpellier - Hôpital Lapeyronie /ID# 228347
    • Sarthe
      • Le Mans CEDEX 9, Sarthe, France, 72037
        • Centre Hospitalier du Mans /ID# 229044
  • Germany
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 228661
      • Berlin-buch, Germany, 13125
        • Immanuel Krankenhaus Berlin /ID# 228659
      • Hamburg, Germany, 20095
        • MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 228658
      • Ratingen, Germany, 40882
        • Rheumazentrum Ratingen /ID# 245183
    • Baden-Wuerttemberg
      • Kirchheim unter Teck, Baden-Wuerttemberg, Germany, 73230
        • Medius Klinik Kirchheim /ID# 228660
  • Hungary
      • Budapest, Hungary, 1033
        • Clinexpert Kft /ID# 229677
      • Budapest, Hungary, 1036
        • Obudai Egeszsegugyi Centrum Kft. /ID# 231121
      • Gyula, Hungary, 5700
        • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 229758
      • Kistarcsa, Hungary, 2143
        • Kistarcsai Flor Ferenc Korhaz /ID# 229676
      • Szekesfehervar, Hungary, 8000
        • CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 230065
      • Szentes, Hungary, 6600
        • Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz /ID# 229793
      • Veszprém, Hungary, 8200
        • Vital Medical Center Orvosi es Fogaszati Kozpont (Vital Medicina Kft.) /ID# 229674
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont /ID# 241674
    • Zala
      • Zalaegerszeg, Zala, Hungary, 8900
        • Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 229759
  • Italy
      • Modena, Italy, 41124
        • Azienda Ospedaliero-Universitaria di Modena /ID# 228825
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico /ID# 245274
      • Siena, Italy, 53100
        • Azienda Ospedaliero-Universitaria Senese-Ospedale Santa Maria delle Scotte /ID# 245273
      • Udine, Italy, 33100
        • Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 228815
    • Genova
      • Arenzano, Genova, Italy, 16011
        • ASL 3 Genovese - Ospedale la Colletta /ID# 229282
    • Torino
      • Turin, Torino, Italy, 10126
        • A.O.U. Citta della Salute e della Scienza di Torino /ID# 229080
  • Japan
    • Aichi
      • Nagoya-shi, Aichi, Japan, 457-8511
        • Daido Clinic /ID# 230204
      • Nagoya-shi, Aichi, Japan, 460-0001
        • NHO Nagoya Medical Center /ID# 232420
    • Chiba
      • Yotsukaido-shi, Chiba, Japan, 284-0003
        • National Hospital Organization Shimoshizu National Hospital /ID# 230500
    • Ehime
      • Matsuyama-shi, Ehime, Japan, 790-8524
        • Matsuyama Red Cross Hospital /ID# 230458
    • Kagawa
      • Sanuki-shi, Kagawa, Japan, 769-2393
        • Sanuki Municipal Hospital /ID# 230202
    • Mie
      • Kuwana-shi, Mie, Japan, 511-0061
        • Kuwana city medical center /ID# 231936
    • Oita
      • Beppu-shi, Oita, Japan, 874-0838
        • Kyushu University Beppu Hospital /ID# 232250
    • Okayama
      • Okayama-shi, Okayama, Japan, 700-8607
        • Japanese Red Cross Okayama Hospital /ID# 230857
    • Osaka
      • Izumisano-shi, Osaka, Japan, 598-0048
        • Rinku Hashimoto Rheumatology Orthopaedics /ID# 246532
      • Takatsuki-shi, Osaka, Japan, 569-8686
        • Osaka Medical and Pharmaceutical University Hospital /ID# 246530
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Tokyo Medical And Dental University Hospital /ID# 232206
    • Toyama
      • Toyama-shi, Toyama, Japan, 930-8550
        • Toyama Prefectural Central Hospital /ID# 230616
  • Korea, Republic of
      • Daegu, Korea, Republic of, 41944
        • Kyungpook National University Hospital /ID# 228716
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 04763
        • Hanyang University Seoul Hospital /ID# 228719
  • Netherlands
      • Almelo, Netherlands, 7609 PP
        • ZiekenhuisGroep Twente /ID# 229071
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen /ID# 227727
      • Leeuwarden, Netherlands, 8934 AD
        • Medisch Centrum Leeuwarden /ID# 245442
      • Maastricht, Netherlands, 6229 HX
        • Maastricht Universitair Medisch Centrum /ID# 227779
      • Rotterdam, Netherlands, 3079 DZ
        • Maasstad Ziekenhuis /ID# 228064
  • New Zealand
      • Christchurch Central, New Zealand, 8011
        • CGM Research Trust /ID# 244893
    • Auckland
      • Grafotn, Auckland, New Zealand, 1010
        • Optimal Clinical Trials Ltd /ID# 229048
      • Papatoetoe, Auckland, New Zealand, 2025
        • Aotearoa Clinical Trials /ID# 229099
    • Canterbury
      • Timaru, Canterbury, New Zealand, 7910
        • Timaru Medical Specialists Ltd /ID# 229098
    • Waikato
      • Hamilton, Waikato, New Zealand, 3240
        • Waikato Hospital /ID# 229047
    • Wellington
      • Newtown, Wellington, New Zealand, 6021
        • Wellington Regional Hospital /ID# 229490
  • Poland
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 53-224
        • Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o /ID# 228357
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
        • Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 228353
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-665
        • Centrum Medyczne Reuma Park /ID# 244813
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-707
        • Nova Reuma Domyslawska I Rusilowicz - Spolka Partnerska Lekarza Reumatologa I Fi /Id# 228466
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 61-113
        • AI Centrum Medyczne Sp. z o.o. sp.k. /ID# 228951
      • Poznan, Wielkopolskie, Poland, 61-545
        • Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 228314
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona /ID# 229295
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon /ID# 229302
      • Madrid, Spain, 28040
        • Hospital Clinico Universitario San Carlos /ID# 229296
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain, 15706
        • Hospital Clínico Universitario de Santiago-CHUS /ID# 244868
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 244866
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla /ID# 229297
    • Santa Cruz De Tenerife
      • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
        • Hospital Universitario Canarias /ID# 229451
  • United Kingdom
      • Coventry, United Kingdom, CV2 2DX
        • UH Coventry & Warwickshire /ID# 228588
      • Edinburgh, United Kingdom, EH3 9HE
        • NHS Lothian /ID# 245293
      • Liverpool, United Kingdom, L7 8XP
        • Liverpool University Hospitals NHS Foundation Trust /ID# 245296
      • Portsmouth, United Kingdom, PO6 3LY
        • Portsmouth Hospitals University NHS Trust /ID# 245291
    • Cambridgeshire
      • Bretton, Cambridgeshire, United Kingdom, PE3 9GZ
        • North West Anglia NHS Foundation Trust /ID# 230866
    • England
      • Leicester, England, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary /ID# 231967
    • London, City Of
      • London, London, City Of, United Kingdom, NW3 2QG
        • The Royal Free London NHS Foundation Trust /ID# 231707
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 231966
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XN
        • Cardiff & Vale University Health Board /ID# 245297
  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401-6251
        • Arthritis and Rheumatism Associates /ID# 232089
    • California
      • Fullerton, California, United States, 92835
        • Providence Medical Foundation /ID# 228681
      • Huntington Beach, California, United States, 92648
        • Care Access Research, Huntington Beach /ID# 228677
      • La Mesa, California, United States, 91942
        • Purushotham & Akther Kotha MD, Inc /ID# 245391
      • La Palma, California, United States, 90623-1728
        • Arthritis & Osteo Medical Ctr /ID# 228680
      • Santa Barbara, California, United States, 93108
        • Hans Richard Barthel, M.D., Inc /ID# 231902
      • Tujunga, California, United States, 91042-2706
        • Medvin Clinical Research /ID# 228675
      • Upland, California, United States, 91786
        • Inland Rheum & Osteo Med Grp /ID# 228679
    • Colorado
      • Denver, Colorado, United States, 80230
        • Denver Arthritis Clinic /ID# 245736
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Delaware Arthritis /ID# 230110
    • Florida
      • Aventura, Florida, United States, 33180
        • Arthritis & Rheumatic Disease Specialties /ID# 245448
      • Boca Raton, Florida, United States, 33486
        • Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 232238
      • Daytona Beach, Florida, United States, 32117
        • International Medical Research /ID# 228765
      • DeBary, Florida, United States, 32713-2260
        • Omega Research Debary, LLC /ID# 245450
      • Miami, Florida, United States, 33014
        • Lakes Research, LLC /ID# 228757
      • Orlando, Florida, United States, 32819
        • HMD Research LLC /ID# 228767
    • Illinois
      • Springfield, Illinois, United States, 62702-3749
        • Springfield Clinic /ID# 228840
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Four Rivers Clinical Research /ID# 228858
    • Mississippi
      • Tupelo, Mississippi, United States, 38801-4949
        • Rheumatology Consultants - Clinical Research /ID# 232137
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center /ID# 229557
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Ocean Rheumatology, PA /ID# 232539
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery /ID# 228577
      • Potsdam, New York, United States, 13676
        • St. Lawrence Health System /ID# 229702
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center /ID# 232554
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research Con /ID# 228839
      • Perrysburg, Ohio, United States, 43551
        • Clinical Research Source, Inc. /ID# 231903
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Ctr Clinical Res /ID# 232493
    • South Carolina
      • Summerville, South Carolina, United States, 29486-7887
        • Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 228860
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • West Tennessee Research Institute /ID# 228854
    • Texas
      • Bellaire, Texas, United States, 77401-2900
        • Rheumatology Care Center PLLC /ID# 232306
      • Tomball, Texas, United States, 77375
        • DM Clinical Research - Tomball /ID# 245512

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABBV-154 Dose A
Participants 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.
Drug: ABBV-154
Subcutaneous Injection
Drug: Glucocorticoid
Oral Tablet
Experimental: ABBV-154 Dose B
Participants 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.
Drug: ABBV-154
Subcutaneous Injection
Drug: Glucocorticoid
Oral Tablet
Experimental: ABBV-154 Dose C
Participants 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.
Drug: ABBV-154
Subcutaneous Injection
Drug: Glucocorticoid
Oral Tablet
Placebo Comparator: Placebo
Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Drug: Placebo
Subcutaneous Injection
Drug: Glucocorticoid
Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Flare
Time Frame: From first dose of study drug to Week 52
Flare is defined as, presence of clinical signs and symptoms of PMR and requirement to increase the glucocorticoid dose per investigator.
From first dose of study drug to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Flare-Free State
Time Frame: Up to Week 24
Percentage of participants achieving flare-free state.
Up to Week 24
Cumulative Glucocorticoid Dose
Time Frame: Week 24
Cumulative glucocorticoid dose.
Week 24
Change From Baseline in Glucocorticoid Dose
Time Frame: Week 24
Change from Baseline in glucocorticoid dose.
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2021

Primary Completion (Actual)

July 24, 2023

Study Completion (Actual)

July 24, 2023

Study Registration Dates

First Submitted

July 13, 2021

First Submitted That Met QC Criteria

July 13, 2021

First Posted (Actual)

July 22, 2021

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M20-370
  • 2021-000648-23 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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