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

Polymyalgia Rheumatica Clinical Trial

— AIM-PMR  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04972968
• Other study ID #: M20-370
• Secondary ID: 2021-000648-23
• Status: Terminated
• Phase: Phase 2
• Start date: September 9, 2021
• Est. completion date: July 24, 2023

Study information

• Verified date: August 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 181
• Est. completion date: July 24, 2023
• Est. primary completion date: July 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Drug:
• ABBV-154
Subcutaneous Injection
• Placebo
Subcutaneous Injection
• Glucocorticoid
Oral Tablet

Locations

Country	Name	City	State
Australia	Emeritus Research Sydney /ID# 229166	Botany	New South Wales
Australia	Emeritus Research /ID# 229270	Camberwell	Victoria
Australia	Royal Prince Alfred Hospital /ID# 244888	Camperdown	New South Wales
Australia	Austin Health /ID# 229164	Heidelberg	Victoria
Australia	Fiona Stanley Hospital /ID# 229050	Murdoch	Western Australia
Australia	BJC Health /ID# 244839	Paramatta	New South Wales
Australia	Tasman Health Care /ID# 230829	Southport	Queensland
Australia	The Queen Elizabeth Hospital /ID# 229049	Woodville South	South Australia
Austria	Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 229436	Vienna	Wien
Canada	The Waterside Clinic /ID# 230364	Barrie	Ontario
Canada	Rheumatology Research Associates /ID# 230363	Edmonton	Alberta
Canada	CISSSBSL -Hopital regional de Rimouski /ID# 228394	Rimouski	Quebec
Canada	Centre de Recherche Musculo-Squelettique /ID# 228392	Trois-rivières	Quebec
France	CHU de Besancon - Jean Minjoz /ID# 244897	Besancon	Doubs
France	Hopital de la Cavale Blanche /ID# 228348	Brest
France	CHRU Tours - Hopital Trousseau /ID# 228349	Chambray Les Tours
France	Centre Hospitalier du Mans /ID# 229044	Le Mans CEDEX 9	Sarthe
France	CHU Montpellier - Hôpital Lapeyronie /ID# 228347	Montpellier	Herault
France	AP-HP - Hopital Cochin /ID# 231800	Paris
Germany	Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 228661	Berlin
Germany	Immanuel Krankenhaus Berlin /ID# 228659	Berlin-buch
Germany	MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 228658	Hamburg
Germany	Medius Klinik Kirchheim /ID# 228660	Kirchheim unter Teck	Baden-Wuerttemberg
Germany	Rheumazentrum Ratingen /ID# 245183	Ratingen
Hungary	Clinexpert Kft /ID# 229677	Budapest
Hungary	Obudai Egeszsegugyi Centrum Kft. /ID# 231121	Budapest	Pest
Hungary	Debreceni Egyetem Klinikai Kozpont /ID# 241674	Debrecen	Hajdu-Bihar
Hungary	Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 229758	Gyula
Hungary	Pest Megyei Flor Ferenc Korhaz /ID# 229676	Kistarcsa
Hungary	CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 230065	Szekesfehervar
Hungary	Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz /ID# 229793	Szentes
Hungary	Vital Medical Center Orvosi es Fogaszati Kozpont (Vital Medicina Kft.) /ID# 229674	Veszprém
Hungary	Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 229759	Zalaegerszeg
Italy	ASL 3 Genovese - Ospedale la Colletta /ID# 229282	Arenzano	Genova
Italy	Azienda Ospedaliero-Universitaria di Modena /ID# 228825	Modena
Italy	Fondazione IRCCS Policlinico /ID# 245274	Pavia
Italy	Azienda Ospedaliero-Universitaria Senese-Ospedale Santa Maria delle Scotte /ID# 245273	Siena
Italy	A.O.U. Citta della Salute e della Scienza di Torino /ID# 229080	Turin
Italy	Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 228815	Udine
Japan	Kyushu University Beppu Hospital /ID# 232250	Beppu-shi	Oita
Japan	Tokyo Medical And Dental University Hospital /ID# 232206	Bunkyo-ku	Tokyo
Japan	Rinku Hashimoto Rheumatology Orthopaedics /ID# 246532	Izumisano-shi	Osaka
Japan	Kuwana City Medical Center /ID# 231936	Kuwana-shi	Mie
Japan	Matsuyama Red Cross Hospital /ID# 230458	Matsuyama-shi	Ehime
Japan	Daido Clinic /ID# 230204	Nagoya-shi	Aichi
Japan	NHO Nagoya Medical Center /ID# 232420	Nagoya-shi	Aichi
Japan	Japanese Red Cross Okayama Hospital /ID# 230857	Okayama-shi	Okayama
Japan	Sanuki Municipal Hospital /ID# 230202	Sanuki-shi	Kagawa
Japan	Osaka Medical and Pharmaceutical University Hospital /ID# 246530	Takatsuki-shi	Osaka
Japan	Toyama Prefectural Central Hospital /ID# 230616	Toyama-shi	Toyama
Japan	National Hospital Organization Shimoshizu National Hospital /ID# 230500	Yotsukaido-shi	Chiba
Korea, Republic of	Kyungpook National University Hospital /ID# 228716	Daegu
Korea, Republic of	Hanyang University Seoul Hospital /ID# 228719	Seoul	Seoul Teugbyeolsi
Netherlands	ZiekenhuisGroep Twente /ID# 229071	Almelo
Netherlands	Universitair Medisch Centrum Groningen /ID# 227727	Groningen
Netherlands	Medisch Centrum Leeuwarden /ID# 245442	Leeuwarden
Netherlands	Maastricht Universitair Medisch Centrum /ID# 227779	Maastricht
Netherlands	Maasstad Ziekenhuis /ID# 228064	Rotterdam
New Zealand	CGM Research Trust /ID# 244893	Christchurch Central
New Zealand	Optimal Clinical Trials Ltd /ID# 229048	Grafotn	Auckland
New Zealand	Waikato Hospital /ID# 229047	Hamilton	Waikato
New Zealand	Wellington Regional Hospital /ID# 229490	Newtown	Wellington
New Zealand	Aotearoa Clinical Trials /ID# 229099	Papatoetoe	Auckland
New Zealand	Timaru Medical Specialists Ltd /ID# 229098	Timaru	Canterbury
Poland	Nova Reuma Domyslawska I Rusilowicz - Spolka Partnerska Lekarza Reumatologa I Fi /Id# 228466	Bialystok	Podlaskie
Poland	Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 228353	Bydgoszcz	Kujawsko-pomorskie
Poland	AI Centrum Medyczne Sp. z o.o. sp.k. /ID# 228951	Poznan	Wielkopolskie
Poland	Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 228314	Poznan	Wielkopolskie
Poland	Centrum Medyczne Reuma Park /ID# 244813	Warszawa	Mazowieckie
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o /ID# 228357	Wroclaw	Dolnoslaskie
Spain	Hospital Clinic de Barcelona /ID# 229295	Barcelona
Spain	Hospital Clinico Universitario San Carlos /ID# 229296	Madrid
Spain	Hospital General Universitario Gregorio Maranon /ID# 229302	Madrid
Spain	Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 244866	Sabadell	Barcelona
Spain	Hospital Universitario Canarias /ID# 229451	San Cristóbal de La Laguna	Santa Cruz De Tenerife
Spain	Hospital Unversitario Marques de Valdecilla /ID# 229297	Santander	Cantabria
Spain	Hospital Clínico Universitario de Santiago-CHUS /ID# 244868	Santiago de Compostela	A Coruna
United Kingdom	North West Anglia NHS Foundation Trust /ID# 230866	Bretton	Cambridgeshire
United Kingdom	Cardiff & Vale University Health Board /ID# 245297	Cardiff	Wales
United Kingdom	UH Coventry & Warwickshire /ID# 228588	Coventry
United Kingdom	NHS Lothian /ID# 245293	Edinburgh
United Kingdom	Leicester Royal Infirmary /ID# 231967	Leicester	England
United Kingdom	Liverpool University Hospitals NHS Foundation Trust /ID# 245296	Liverpool
United Kingdom	The Royal Free London NHS Foundation Trust /ID# 231707	London	London, City Of
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 231966	Norwich	Norfolk
United Kingdom	Portsmouth Hospitals University NHS Trust /ID# 245291	Portsmouth
United States	Arthritis & Rheumatic Disease Specialties /ID# 245448	Aventura	Florida
United States	Rheumatology Care Center PLLC /ID# 232306	Bellaire	Texas
United States	Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 232238	Boca Raton	Florida
United States	International Medical Research /ID# 228765	Daytona Beach	Florida
United States	Omega Research Debary, LLC /ID# 245450	DeBary	Florida
United States	Denver Arthritis Clinic /ID# 245736	Denver	Colorado
United States	Altoona Ctr Clinical Res /ID# 232493	Duncansville	Pennsylvania
United States	Providence Medical Foundation /ID# 228681	Fullerton	California
United States	Care Access Research, Huntington Beach /ID# 228677	Huntington Beach	California
United States	West Tennessee Research Institute /ID# 228854	Jackson	Tennessee
United States	Arthritis and Rheumatism Associates /ID# 232089	Jonesboro	Arkansas
United States	Purushotham & Akther Kotha MD, Inc /ID# 245391	La Mesa	California
United States	Arthritis & Osteo Medical Ctr /ID# 228680	La Palma	California
United States	Dartmouth-Hitchcock Medical Center /ID# 229557	Lebanon	New Hampshire
United States	Delaware Arthritis /ID# 230110	Lewes	Delaware
United States	Lakes Research, LLC /ID# 228757	Miami	Florida
United States	Paramount Medical Research Con /ID# 228839	Middleburg Heights	Ohio
United States	Hospital for Special Surgery /ID# 228577	New York	New York
United States	HMD Research LLC /ID# 228767	Orlando	Florida
United States	Four Rivers Clinical Research /ID# 228858	Paducah	Kentucky
United States	Clinical Research Source, Inc. /ID# 231903	Perrysburg	Ohio
United States	St. Lawrence Health System /ID# 229702	Potsdam	New York
United States	University of Rochester Medical Center /ID# 232554	Rochester	New York
United States	Hans Richard Barthel, M.D., Inc /ID# 231902	Santa Barbara	California
United States	Springfield Clinic /ID# 228840	Springfield	Illinois
United States	Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 228860	Summerville	South Carolina
United States	DM Clinical Research - Tomball /ID# 245512	Tomball	Texas
United States	Ocean Rheumatology, PA /ID# 232539	Toms River	New Jersey
United States	Medvin Clinical Research /ID# 228675	Tujunga	California
United States	Rheumatology Consultants - Clinical Research /ID# 232137	Tupelo	Mississippi
United States	Inland Rheum & Osteo Med Grp /ID# 228679	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  France,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Flare	Flare is defined as, presence of clinical signs and symptoms of PMR and requirement to increase the glucocorticoid dose per investigator.	Up to Week 52
Secondary	Percentage of Participants Achieving Flare-Free State	Percentage of participants achieving flare-free state.	Up to Week 24
Secondary	Cumulative Glucocorticoid Dose	Cumulative glucocorticoid dose.	Week 24
Secondary	Change from Baseline in Glucocorticoid Dose	Change from Baseline in glucocorticoid dose.	Week 24