Clinical trial NCT04972968: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Polymyalgia Rheumatica
Keywords: Polymyalgia Rheumatica
PMR
ABBV-154
Glucocorticoid
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-07-22
Enrollment: 181
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time to Flare
timeFrame: From first dose of study drug to Week 52
Secondary outcomes:
measure: Percentage of Participants Achieving Flare-Free State
timeFrame: Up to Week 24
measure: Cumulative Glucocorticoid Dose
timeFrame: Week 24
measure: Change From Baseline in Glucocorticoid Dose
timeFrame: Week 24
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Arthritis and Rheumatism Associates /ID# 232089
state: Arkansas
city: Fullerton
country: United States
facility: Providence Medical Foundation /ID# 228681
state: California
city: Huntington Beach
country: United States
facility: Care Access Research, Huntington Beach /ID# 228677
state: California
city: La Mesa
country: United States
facility: Purushotham & Akther Kotha MD, Inc /ID# 245391
state: California
city: La Palma
country: United States
facility: Arthritis & Osteo Medical Ctr /ID# 228680
state: California
city: Santa Barbara
country: United States
facility: Hans Richard Barthel, M.D., Inc /ID# 231902
state: California
city: Tujunga
country: United States
facility: Medvin Clinical Research /ID# 228675
state: California
city: Upland
country: United States
facility: Inland Rheum & Osteo Med Grp /ID# 228679
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic /ID# 245736
state: Colorado
city: Lewes
country: United States
facility: Delaware Arthritis /ID# 230110
state: Delaware
city: Aventura
country: United States
facility: Arthritis & Rheumatic Disease Specialties /ID# 245448
state: Florida
city: Boca Raton
country: United States
facility: Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 232238
state: Florida
city: Daytona Beach
country: United States
facility: International Medical Research /ID# 228765
state: Florida
city: DeBary
country: United States
facility: Omega Research Debary, LLC /ID# 245450
state: Florida
city: Miami
country: United States
facility: Lakes Research, LLC /ID# 228757
state: Florida
city: Orlando
country: United States
facility: HMD Research LLC /ID# 228767
state: Florida
city: Springfield
country: United States
facility: Springfield Clinic /ID# 228840
state: Illinois
city: Paducah
country: United States
facility: Four Rivers Clinical Research /ID# 228858
state: Kentucky
city: Tupelo
country: United States
facility: Rheumatology Consultants - Clinical Research /ID# 232137
state: Mississippi
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center /ID# 229557
state: New Hampshire
city: Toms River
country: United States
facility: Ocean Rheumatology, PA /ID# 232539
state: New Jersey
city: New York
country: United States
facility: Hospital for Special Surgery /ID# 228577
state: New York
city: Potsdam
country: United States
facility: St. Lawrence Health System /ID# 229702
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center /ID# 232554
state: New York
city: Middleburg Heights
country: United States
facility: Paramount Medical Research Con /ID# 228839
state: Ohio
city: Perrysburg
country: United States
facility: Clinical Research Source, Inc. /ID# 231903
state: Ohio
city: Duncansville
country: United States
facility: Altoona Ctr Clinical Res /ID# 232493
state: Pennsylvania
city: Summerville
country: United States
facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 228860
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Institute /ID# 228854
state: Tennessee
city: Bellaire
country: United States
facility: Rheumatology Care Center PLLC /ID# 232306
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - Tomball /ID# 245512
state: Texas
city: Botany
country: Australia
facility: Emeritus Research Sydney /ID# 229166
state: New South Wales
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital /ID# 244888
state: New South Wales
city: Paramatta
country: Australia
facility: BJC Health /ID# 244839
state: New South Wales
city: Southport
country: Australia
facility: Tasman Health Care /ID# 230829
state: Queensland
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital /ID# 229049
state: South Australia
city: Camberwell
country: Australia
facility: Emeritus Research /ID# 229270
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health /ID# 229164
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital /ID# 229050
state: Western Australia
city: Vienna
country: Austria
facility: Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 229436
state: Wien
city: Edmonton
country: Canada
facility: Rheumatology Research Associates /ID# 230363
state: Alberta
city: Barrie
country: Canada
facility: The Waterside Clinic /ID# 230364
state: Ontario
city: Rimouski
country: Canada
facility: CISSSBSL -Hopital regional de Rimouski /ID# 228394
state: Quebec
city: Trois-rivières
country: Canada
facility: Centre de Recherche Musculo-Squelettique /ID# 228392
state: Quebec
city: Besancon
country: France
facility: CHU de Besancon - Jean Minjoz /ID# 244897
state: Doubs
city: Brest
country: France
facility: Hopital de la Cavale Blanche /ID# 228348
state: Finistere
city: Montpellier
country: France
facility: CHU Montpellier - Hôpital Lapeyronie /ID# 228347
state: Herault
city: Le Mans CEDEX 9
country: France
facility: Centre Hospitalier du Mans /ID# 229044
state: Sarthe
city: Chambray Les Tours
country: France
facility: CHRU Tours - Hopital Trousseau /ID# 228349
city: Paris
country: France
facility: AP-HP - Hopital Cochin /ID# 231800
city: Kirchheim unter Teck
country: Germany
facility: Medius Klinik Kirchheim /ID# 228660
state: Baden-Wuerttemberg
city: Berlin-buch
country: Germany
facility: Immanuel Krankenhaus Berlin /ID# 228659
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 228661
city: Hamburg
country: Germany
facility: MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 228658
city: Ratingen
country: Germany
facility: Rheumazentrum Ratingen /ID# 245183
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont /ID# 241674
state: Hajdu-Bihar
city: Zalaegerszeg
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 229759
state: Zala
city: Budapest
country: Hungary
facility: Clinexpert Kft /ID# 229677
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft. /ID# 231121
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 229758
city: Kistarcsa
country: Hungary
facility: Kistarcsai Flor Ferenc Korhaz /ID# 229676
city: Szekesfehervar
country: Hungary
facility: CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 230065
city: Szentes
country: Hungary
facility: Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz /ID# 229793
city: Veszprém
country: Hungary
facility: Vital Medical Center Orvosi es Fogaszati Kozpont (Vital Medicina Kft.) /ID# 229674
city: Arenzano
country: Italy
facility: ASL 3 Genovese - Ospedale la Colletta /ID# 229282
state: Genova
city: Turin
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino /ID# 229080
state: Torino
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena /ID# 228825
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico /ID# 245274
city: Siena
country: Italy
facility: Azienda Ospedaliero-Universitaria Senese-Ospedale Santa Maria delle Scotte /ID# 245273
city: Udine
country: Italy
facility: Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 228815
city: Nagoya-shi
country: Japan
facility: Daido Clinic /ID# 230204
state: Aichi
city: Nagoya-shi
country: Japan
facility: NHO Nagoya Medical Center /ID# 232420
state: Aichi
city: Yotsukaido-shi
country: Japan
facility: National Hospital Organization Shimoshizu National Hospital /ID# 230500
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Matsuyama Red Cross Hospital /ID# 230458
state: Ehime
city: Sanuki-shi
country: Japan
facility: Sanuki Municipal Hospital /ID# 230202
state: Kagawa
city: Kuwana-shi
country: Japan
facility: Kuwana city medical center /ID# 231936
state: Mie
city: Beppu-shi
country: Japan
facility: Kyushu University Beppu Hospital /ID# 232250
state: Oita
city: Okayama-shi
country: Japan
facility: Japanese Red Cross Okayama Hospital /ID# 230857
state: Okayama
city: Izumisano-shi
country: Japan
facility: Rinku Hashimoto Rheumatology Orthopaedics /ID# 246532
state: Osaka
city: Takatsuki-shi
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital /ID# 246530
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical And Dental University Hospital /ID# 232206
state: Tokyo
city: Toyama-shi
country: Japan
facility: Toyama Prefectural Central Hospital /ID# 230616
state: Toyama
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital /ID# 228719
state: Seoul Teugbyeolsi
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital /ID# 228716
city: Almelo
country: Netherlands
facility: ZiekenhuisGroep Twente /ID# 229071
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen /ID# 227727
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden /ID# 245442
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum /ID# 227779
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis /ID# 228064
city: Grafotn
country: New Zealand
facility: Optimal Clinical Trials Ltd /ID# 229048
state: Auckland
city: Papatoetoe
country: New Zealand
facility: Aotearoa Clinical Trials /ID# 229099
state: Auckland
city: Timaru
country: New Zealand
facility: Timaru Medical Specialists Ltd /ID# 229098
state: Canterbury
city: Hamilton
country: New Zealand
facility: Waikato Hospital /ID# 229047
state: Waikato
city: Newtown
country: New Zealand
facility: Wellington Regional Hospital /ID# 229490
state: Wellington
city: Christchurch Central
country: New Zealand
facility: CGM Research Trust /ID# 244893
city: Wroclaw
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o /ID# 228357
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 228353
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Centrum Medyczne Reuma Park /ID# 244813
state: Mazowieckie
city: Bialystok
country: Poland
facility: Nova Reuma Domyslawska I Rusilowicz - Spolka Partnerska Lekarza Reumatologa I Fi /Id# 228466
state: Podlaskie
city: Poznan
country: Poland
facility: AI Centrum Medyczne Sp. z o.o. sp.k. /ID# 228951
state: Wielkopolskie
city: Poznan
country: Poland
facility: Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 228314
state: Wielkopolskie
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 244868
state: A Coruna
city: Sabadell
country: Spain
facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 244866
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla /ID# 229297
state: Cantabria
city: San Cristóbal de La Laguna
country: Spain
facility: Hospital Universitario Canarias /ID# 229451
state: Santa Cruz De Tenerife
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 229295
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 229302
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos /ID# 229296
city: Bretton
country: United Kingdom
facility: North West Anglia NHS Foundation Trust /ID# 230866
state: Cambridgeshire
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary /ID# 231967
state: England
city: London
country: United Kingdom
facility: The Royal Free London NHS Foundation Trust /ID# 231707
state: London, City Of
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 231966
state: Norfolk
city: Cardiff
country: United Kingdom
facility: Cardiff & Vale University Health Board /ID# 245297
state: Wales
city: Coventry
country: United Kingdom
facility: UH Coventry & Warwickshire /ID# 228588
city: Edinburgh
country: United Kingdom
facility: NHS Lothian /ID# 245293
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust /ID# 245296
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals University NHS Trust /ID# 245291
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: