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

NCT04972968 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: M20-3702021-000648-23
• Study Type: interventional
• Target: 181
• Locations: 14 countries
• Sites: 109

Brief 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. 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.

Conditions

Polymyalgia Rheumatica

Keywords

Polymyalgia Rheumatica; PMR; ABBV-154; Glucocorticoid

Outcome Measures

Primary Outcomes (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.

  From first dose of study drug to Week 52

Secondary Outcomes (3)

• Percentage of Participants Achieving Flare-Free State

  Up to Week 24

• Cumulative Glucocorticoid Dose

  Week 24

• Change From Baseline in Glucocorticoid Dose

  Week 24

Study Arms (4)

ABBV-154 Dose A

EXPERIMENTAL

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; Drug: Glucocorticoid

ABBV-154 Dose B

EXPERIMENTAL

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; Drug: Glucocorticoid

ABBV-154 Dose C

EXPERIMENTAL

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; Drug: Glucocorticoid

Placebo

PLACEBO COMPARATOR

Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.

Drug: Placebo; Drug: Glucocorticoid

Interventions

ABBV-154 DRUG

Subcutaneous Injection

ABBV-154 Dose A; ABBV-154 Dose B; ABBV-154 Dose C

Placebo DRUG

Subcutaneous Injection

Placebo

Glucocorticoid DRUG

Oral Tablet

ABBV-154 Dose A; ABBV-154 Dose B; ABBV-154 Dose C; Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (117)

Arthritis and Rheumatism Associates /ID# 232089

Jonesboro, Arkansas, 72401-6251, United States

Location

Providence Medical Foundation /ID# 228681

Fullerton, California, 92835, United States

Location

Care Access Research, Huntington Beach /ID# 228677

Huntington Beach, California, 92648, United States

Location

Purushotham & Akther Kotha MD, Inc /ID# 245391

La Mesa, California, 91942, United States

Location

Arthritis & Osteo Medical Ctr /ID# 228680

La Palma, California, 90623-1728, United States

Location

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

Santa Barbara, California, 93108, United States

Location

Medvin Clinical Research /ID# 228675

Tujunga, California, 91042-2706, United States

Location

Inland Rheum & Osteo Med Grp /ID# 228679

Upland, California, 91786, United States

Location

Denver Arthritis Clinic /ID# 245736

Denver, Colorado, 80230, United States

Location

Delaware Arthritis /ID# 230110

Lewes, Delaware, 19958, United States

Location

Arthritis & Rheumatic Disease Specialties /ID# 245448

Aventura, Florida, 33180, United States

Location

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

Boca Raton, Florida, 33486, United States

Location

International Medical Research /ID# 228765

Daytona Beach, Florida, 32117, United States

Location

Omega Research Debary, LLC /ID# 245450

DeBary, Florida, 32713-2260, United States

Location

Lakes Research, LLC /ID# 228757

Miami, Florida, 33014, United States

Location

HMD Research LLC /ID# 228767

Orlando, Florida, 32819, United States

Location

Springfield Clinic /ID# 228840

Springfield, Illinois, 62702-3749, United States

Location

Four Rivers Clinical Research /ID# 228858

Paducah, Kentucky, 42001, United States

Location

Rheumatology Consultants - Clinical Research /ID# 232137

Tupelo, Mississippi, 38801-4949, United States

Location

Dartmouth-Hitchcock Medical Center /ID# 229557

Lebanon, New Hampshire, 03756, United States

Location

Ocean Rheumatology, PA /ID# 232539

Toms River, New Jersey, 08755, United States

Location

Hospital for Special Surgery /ID# 228577

New York, New York, 10021, United States

Location

St. Lawrence Health System /ID# 229702

Potsdam, New York, 13676, United States

Location

University of Rochester Medical Center /ID# 232554

Rochester, New York, 14642, United States

Location

Paramount Medical Research Con /ID# 228839

Middleburg Heights, Ohio, 44130, United States

Location

Clinical Research Source, Inc. /ID# 231903

Perrysburg, Ohio, 43551, United States

Location

Altoona Ctr Clinical Res /ID# 232493

Duncansville, Pennsylvania, 16635, United States

Location

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

Summerville, South Carolina, 29486-7887, United States

Location

West Tennessee Research Institute /ID# 228854

Jackson, Tennessee, 38305, United States

Location

Rheumatology Care Center PLLC /ID# 232306

Bellaire, Texas, 77401-2900, United States

Location

DM Clinical Research - Tomball /ID# 245512

Tomball, Texas, 77375, United States

Location

Emeritus Research Sydney /ID# 229166

Botany, New South Wales, 2019, Australia

Location

Royal Prince Alfred Hospital /ID# 244888

Camperdown, New South Wales, 2050, Australia

Location

BJC Health /ID# 244839

Paramatta, New South Wales, 2150, Australia

Location

Tasman Health Care /ID# 230829

Southport, Queensland, 4215, Australia

Location

The Queen Elizabeth Hospital /ID# 229049

Woodville South, South Australia, 5011, Australia

Location

Emeritus Research /ID# 229270

Camberwell, Victoria, 3124, Australia

Location

Austin Health /ID# 229164

Heidelberg, Victoria, 3084, Australia

Location

Fiona Stanley Hospital /ID# 229050

Murdoch, Western Australia, 6150, Australia

Location

Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 229436

Vienna, Vienna, 1100, Austria

Location

Rheumatology Research Associates /ID# 230363

Edmonton, Alberta, T5M 0H4, Canada

Location

The Waterside Clinic /ID# 230364

Barrie, Ontario, L4M 6L2, Canada

Location

CISSSBSL -Hopital regional de Rimouski /ID# 228394

Rimouski, Quebec, G5L 5T1, Canada

Location

Centre de Recherche Musculo-Squelettique /ID# 228392

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

CHU de Besancon - Jean Minjoz /ID# 244897

Besançon, Doubs, 25030, France

Location

Hopital de la Cavale Blanche /ID# 228348

Brest, Finistere, 29200, France

Location

CHU Montpellier - Hôpital Lapeyronie /ID# 228347

Montpellier, Herault, 34090, France

Location

Centre Hospitalier du Mans /ID# 229044

Le Mans, Sarthe, 72037, France

Location

CHRU Tours - Hopital Trousseau /ID# 228349

Chambray-lès-Tours, 37170, France

Location

AP-HP - Hopital Cochin /ID# 231800

Paris, 75014, France

Location

Medius Klinik Kirchheim /ID# 228660

Kirchheim unter Teck, Baden-Wurttemberg, 73230, Germany

Location

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 228661

Berlin, 10117, Germany

Location

Immanuel Krankenhaus Berlin /ID# 228659

Buch, 13125, Germany

Location

MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 228658

Hamburg, 20095, Germany

Location

Rheumazentrum Ratingen /ID# 245183

Ratingen, 40882, Germany

Location

Debreceni Egyetem Klinikai Kozpont /ID# 241674

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 229759

Zalaegerszeg, Zala County, 8900, Hungary

Location

Clinexpert Kft /ID# 229677

Budapest, 1033, Hungary

Location

Obudai Egeszsegugyi Centrum Kft. /ID# 231121

Budapest, 1036, Hungary

Location

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 229758

Gyula, 5700, Hungary

Location

Kistarcsai Flor Ferenc Korhaz /ID# 229676

Kistarcsa, 2143, Hungary

Location

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

Szentes, 6600, Hungary

Location

CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 230065

Székesfehérvár, 8000, Hungary

Location

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

Veszprém, 8200, Hungary

Location

ASL 3 Genovese - Ospedale la Colletta /ID# 229282

Arenzano, Genova, 16011, Italy

Location

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

Turin, Torino, 10126, Italy

Location

Azienda Ospedaliero-Universitaria di Modena /ID# 228825

Modena, 41124, Italy

Location

Fondazione IRCCS Policlinico /ID# 245274

Pavia, 27100, Italy

Location

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

Siena, 53100, Italy

Location

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

Udine, 33100, Italy

Location

Daido Clinic /ID# 230204

Nagoya, Aichi-ken, 457-8511, Japan

Location

NHO Nagoya Medical Center /ID# 232420

Nagoya, Aichi-ken, 460-0001, Japan

Location

National Hospital Organization Shimoshizu National Hospital /ID# 230500

Yotsukaido-shi, Chiba, 284-0003, Japan

Location

Matsuyama Red Cross Hospital /ID# 230458

Matsuyama, Ehime, 790-8524, Japan

Location

Sanuki Municipal Hospital /ID# 230202

Sanuki-shi, Kagawa-ken, 769-2393, Japan

Location

Kuwana city medical center /ID# 231936

Kuwana-shi, Mie-ken, 511-0061, Japan

Location

Kyushu University Beppu Hospital /ID# 232250

Beppu-shi, Oita Prefecture, 874-0838, Japan

Location

Japanese Red Cross Okayama Hospital /ID# 230857

Okayama, Okayama-ken, 700-8607, Japan

Location

Rinku Hashimoto Rheumatology Orthopaedics /ID# 246532

Izumisano, Osaka, 598-0048, Japan

Location

Osaka Medical and Pharmaceutical University Hospital /ID# 246530

Takatsuki-shi, Osaka, 569-8686, Japan

Location

Tokyo Medical And Dental University Hospital /ID# 232206

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Toyama Prefectural Central Hospital /ID# 230616

Toyama, Toyama, 930-8550, Japan

Location

ZiekenhuisGroep Twente /ID# 229071

Almelo, 7609 PP, Netherlands

Location

Universitair Medisch Centrum Groningen /ID# 227727

Groningen, 9713 GZ, Netherlands

Location

Medisch Centrum Leeuwarden /ID# 245442

Leeuwarden, 8934 AD, Netherlands

Location

Maastricht Universitair Medisch Centrum /ID# 227779

Maastricht, 6229 HX, Netherlands

Location

Maasstad Ziekenhuis /ID# 228064

Rotterdam, 3079 DZ, Netherlands

Location

Optimal Clinical Trials Ltd /ID# 229048

Grafotn, Auckland, 1010, New Zealand

Location

Aotearoa Clinical Trials /ID# 229099

Papatoetoe, Auckland, 2025, New Zealand

Location

Timaru Medical Specialists Ltd /ID# 229098

Timaru, Canterbury, 7910, New Zealand

Location

Waikato Hospital /ID# 229047

Hamilton, Waikato Region, 3240, New Zealand

Location

Wellington Regional Hospital /ID# 229490

Newtown, Wellington Region, 6021, New Zealand

Location

CGM Research Trust /ID# 244893

Christchurch Central, 8011, New Zealand

Location

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

Poznan, Greater Poland Voivodeship, 61-113, Poland

Location

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

Poznan, Greater Poland Voivodeship, 61-545, Poland

Location

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

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

Location

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

Wroclaw, Lower Silesian Voivodeship, 53-224, Poland

Location

Centrum Medyczne Reuma Park /ID# 244813

Warsaw, Masovian Voivodeship, 02-665, Poland

Location

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

Bialystok, Podlaskie Voivodeship, 15-707, Poland

Location

Hanyang University Seoul Hospital /ID# 228719

Seoul, Seoul Teugbyeolsi, 04763, South Korea

Location

Kyungpook National University Hospital /ID# 228716

Daegu, 41944, South Korea

Location

Hospital Clínico Universitario de Santiago-CHUS /ID# 244868

Santiago de Compostela, A Coruna, 15706, Spain

Location

Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 244866

Sabadell, Barcelona, 08208, Spain

Location

Hospital Universitario Marques de Valdecilla /ID# 229297

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Canarias /ID# 229451

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

Location

Hospital Clinic de Barcelona /ID# 229295

Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Maranon /ID# 229302

Madrid, 28007, Spain

Location

Hospital Clinico Universitario San Carlos /ID# 229296

Madrid, 28040, Spain

Location

North West Anglia NHS Foundation Trust /ID# 230866

Bretton, Cambridgeshire, PE3 9GZ, United Kingdom

Location

Leicester Royal Infirmary /ID# 231967

Leicester, England, LE1 5WW, United Kingdom

Location

The Royal Free London NHS Foundation Trust /ID# 231707

London, London, City of, NW3 2QG, United Kingdom

Location

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

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Cardiff & Vale University Health Board /ID# 245297

Cardiff, Wales, CF14 4XN, United Kingdom

Location

UH Coventry & Warwickshire /ID# 228588

Coventry, CV2 2DX, United Kingdom

Location

NHS Lothian /ID# 245293

Edinburgh, EH3 9HE, United Kingdom

Location

Liverpool University Hospitals NHS Foundation Trust /ID# 245296

Liverpool, L7 8XP, United Kingdom

Location

Portsmouth Hospitals University NHS Trust /ID# 245291

Portsmouth, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Polymyalgia Rheumatica

Interventions

Glucocorticoids

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Limitations and Caveats

AbbVie has decided to discontinue further subject enrollment in the M20-370 (ABBV-154) study. This decision is not based on a safety or an efficacy signal; rather this decision was made because of a change in AbbVie's development.

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 22, 2021
• Study Start: September 9, 2021
• Primary Completion: July 24, 2023
• Study Completion: July 24, 2023
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• 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/

Locations

HU (9); US (31); DE (5); AU (1); NL (5); PL (6); IT (6); CA (4); NZ (6); GB (9); KR (2); FR (6); ES (7); JP (12)