AIM-PMR: 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

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04972968

Collaborator

(none)

160

Enrollment

119

Locations

Arms

Anticipated Duration (Months)

1.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polymyalgia Rheumatica	Drug: ABBV-154 Drug: Placebo Drug: Glucocorticoid	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 9, 2021

Anticipated Primary Completion Date :

Jul 17, 2023

Anticipated Study Completion Date :

Apr 9, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Time to Flare [Up to Week 52]
Flare is defined as, presence of clinical signs and symptoms of PMR and requirement to increase the glucocorticoid dose per investigator.

Secondary Outcome Measures

Percentage of Participants Achieving Flare-Free State [Up to Week 24]
Percentage of participants achieving flare-free state.
Cumulative Glucocorticoid Dose [Week 24]
Cumulative glucocorticoid dose.
Change from Baseline in Glucocorticoid Dose [Week 24]
Change from Baseline in glucocorticoid dose.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arthritis and Rheumatism Associates /ID# 232089	Jonesboro	Arkansas	United States	72401-6251
2	Providence Medical Foundation /ID# 228681	Fullerton	California	United States	92835
3	Care Access Research, Huntington Beach /ID# 228677	Huntington Beach	California	United States	92648
4	San Diego Rheumatology /ID# 245391	La Mesa	California	United States	91942
5	Arthritis & Osteo Medical Ctr /ID# 228680	La Palma	California	United States	90623-1728
6	Hans Richard Barthel, M.D., Inc /ID# 231902	Santa Barbara	California	United States	93108
7	Medvin Clinical Research /ID# 228675	Tujunga	California	United States	91042-2706
8	Inland Rheum & Osteo Med Grp /ID# 228679	Upland	California	United States	91786
9	Denver Arthritis Clinic /ID# 245736	Denver	Colorado	United States	80230
10	Delaware Arthritis /ID# 230110	Lewes	Delaware	United States	19958
11	Arthritis & Rheumatic Disease Specialties /ID# 245448	Aventura	Florida	United States	33180
12	Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 232238	Boca Raton	Florida	United States	33486
13	International Medical Research - Daytona /ID# 228765	Daytona Beach	Florida	United States	32117
14	Omega Research Debary, LLC /ID# 245450	DeBary	Florida	United States	32713-2260
15	Lakes Research, LLC /ID# 228757	Miami	Florida	United States	33014
16	HMD Research LLC /ID# 228767	Orlando	Florida	United States	32819
17	Springfield Clinic /ID# 228840	Springfield	Illinois	United States	62702-3749
18	Four Rivers Clinical Research /ID# 228858	Paducah	Kentucky	United States	42001
19	Rheumatology Consultants - Clinical Research /ID# 232137	Tupelo	Mississippi	United States	38801-4949
20	Dartmouth-Hitchcock Medical Center /ID# 229557	Lebanon	New Hampshire	United States	03756
21	Ocean Rheumatology, PA /ID# 232539	Toms River	New Jersey	United States	08755
22	Hospital for Special Surgery /ID# 228577	New York	New York	United States	10021
23	St. Lawrence Health System /ID# 229702	Potsdam	New York	United States	13676
24	Univ Rochester Med Ctr /ID# 232554	Rochester	New York	United States	14642
25	Paramount Medical Research Con /ID# 228839	Middleburg Heights	Ohio	United States	44130
26	Clinical Research Source, Inc. /ID# 231903	Perrysburg	Ohio	United States	43551
27	Altoona Ctr Clinical Res /ID# 232493	Duncansville	Pennsylvania	United States	16635
28	Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 228860	Summerville	South Carolina	United States	29486-7887
29	West Tennessee Research Institute /ID# 228854	Jackson	Tennessee	United States	38305
30	Rheumatology Care Center PLLC /ID# 232306	Bellaire	Texas	United States	77401-2900
31	DM Clinical Research - Tomball /ID# 245512	Tomball	Texas	United States	77375
32	Emeritus Research Sydney /ID# 229166	Botany	New South Wales	Australia	2019
33	Royal Prince Alfred Hospital /ID# 244888	Camperdown	New South Wales	Australia	2050
34	BJC Health /ID# 244839	Paramatta	New South Wales	Australia	2150
35	Tasman Health Care /ID# 230829	Southport	Queensland	Australia	4215
36	The Queen Elizabeth Hospital /ID# 229049	Woodville South	South Australia	Australia	5011
37	Emeritus Research /ID# 229270	Camberwell	Victoria	Australia	3124
38	Austin Health /ID# 229164	Heidelberg	Victoria	Australia	3084
39	Fiona Stanley Hospital /ID# 229050	Murdoch	Western Australia	Australia	6150
40	Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 229436	Vienna	Wien	Austria	1100
41	Rheumatology Research Associates /ID# 230363	Edmonton	Alberta	Canada	T5M 0H4
42	The Waterside Clinic /ID# 230364	Barrie	Ontario	Canada	L4M 6L2
43	CISSSBSL -Hopital regional de Rimouski /ID# 228394	Rimouski	Quebec	Canada	G5L 5T1
44	Centre de Recherche Musculo-Squelettique /ID# 228392	Trois-rivières	Quebec	Canada	G8Z 1Y2
45	CHU de Besancon - Jean Minjoz /ID# 244897	Besancon	Doubs	France	25030
46	CHU Montpellier - Hôpital Lapeyronie /ID# 228347	Montpellier	Herault	France	34090
47	Centre Hospitalier du Mans /ID# 229044	Le Mans CEDEX 9	Sarthe	France	72037
48	Hopital de la Cavale Blanche /ID# 228348	Brest		France	29200
49	CHRU Tours - Hopital Trousseau /ID# 228349	Chambray Les Tours		France	37170
50	AP-HP - Hopital Cochin /ID# 231800	Paris		France	75014
51	Medius Klinik Kirchheim /ID# 228660	Kirchheim unter Teck	Baden-Wuerttemberg	Germany	73230
52	Immanuel Krankenhaus Berlin /ID# 228659	Berlin-buch		Germany	13125
53	Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 228661	Berlin		Germany	10117
54	MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 228658	Hamburg		Germany	20095
55	Rheumazentrum Ratingen /ID# 245183	Ratingen		Germany	40882
56	Debreceni Egyetem Klinikai Kozpont /ID# 241674	Debrecen	Hajdu-Bihar	Hungary	4032
57	Obudai Egeszsegugyi Centrum Kft. /ID# 231121	Budapest	Pest	Hungary	1036
58	Clinexpert Kft /ID# 229677	Budapest		Hungary	1033
59	Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 229758	Gyula		Hungary	5700
60	Pest Megyei Flor Ferenc Korhaz /ID# 229676	Kistarcsa		Hungary	2143
61	CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 230065	Szekesfehervar		Hungary	8000
62	Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz /ID# 229793	Szentes		Hungary	6600
63	Vital Medical Center Orvosi es Fogaszati Kozpont (Vital Medicina Kft.) /ID# 229674	Veszprém		Hungary	8200
64	Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 229759	Zalaegerszeg		Hungary	8900
65	ASL 3 Genovese - Ospedale la Colletta /ID# 229282	Arenzano	Genova	Italy	16011
66	Azienda Ospedaliero-Universitaria di Modena /ID# 228825	Modena		Italy	41124
67	Fondazione IRCCS Policlinico /ID# 245274	Pavia		Italy	27100
68	Azienda Ospedaliero-Universitaria Senese-Ospedale Santa Maria delle Scotte /ID# 245273	Siena		Italy	53100
69	A.O.U. Citta della Salute e della Scienza di Torino /ID# 229080	Turin		Italy	10126
70	Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 228815	Udine		Italy	33100
71	Daido Clinic /ID# 230204	Nagoya-shi	Aichi	Japan	457-8511
72	NHO Nagoya Medical Center /ID# 232420	Nagoya-shi	Aichi	Japan	460-0001
73	National Hospital Organization Shimoshizu National Hospital /ID# 230500	Yotsukaido-shi	Chiba	Japan	284-0003
74	Matsuyama Red Cross Hospital /ID# 230458	Matsuyama-shi	Ehime	Japan	790-8524
75	Sanuki Municipal Hospital /ID# 230202	Sanuki-shi	Kagawa	Japan	769-2393
76	Kuwana City Medical Center /ID# 231936	Kuwana-shi	Mie	Japan	511-0061
77	Kyushu University Beppu Hospital /ID# 232250	Beppu-shi	Oita	Japan	874-0838
78	Japanese Red Cross Okayama Hospital /ID# 230857	Okayama-shi	Okayama	Japan	700-8607
79	Rinku Hashimoto Rheumatology Orthopaedics /ID# 246532	Izumisano-shi	Osaka	Japan	598-0048
80	Osaka Medical and Pharmaceutical University Hospital /ID# 246530	Takatsuki-shi	Osaka	Japan	569-8686
81	Tokyo Medical And Dental University Hospital /ID# 232206	Bunkyo-ku	Tokyo	Japan	113-8519
82	Toyama Prefectural Central Hospital /ID# 230616	Toyama-shi	Toyama	Japan	930-8550
83	Hanyang University Seoul Hospital /ID# 228719	Seoul	Seoul Teugbyeolsi	Korea, Republic of	04763
84	Kyungpook National University Hospital /ID# 228716	Daegu		Korea, Republic of	41944
85	ZiekenhuisGroep Twente /ID# 229071	Almelo		Netherlands	7609 PP
86	Universitair Medisch Centrum Groningen /ID# 227727	Groningen		Netherlands	9713 GZ
87	Medisch Centrum Leeuwarden /ID# 245442	Leeuwarden		Netherlands	8934 AD
88	Maastricht Universitair Medisch Centrum /ID# 227779	Maastricht		Netherlands	6229 HX
89	Maasstad Ziekenhuis /ID# 228064	Rotterdam		Netherlands	3079 DZ
90	Optimal Clinical Trials Ltd /ID# 229048	Grafotn	Auckland	New Zealand	1010
91	Middlemore Clinical Trials /ID# 229099	Papatoetoe	Auckland	New Zealand	2025
92	Timaru Medical Specialists Ltd /ID# 229098	Timaru	Canterbury	New Zealand	7910
93	Waikato Hospital /ID# 229047	Hamilton	Waikato	New Zealand	3240
94	Wellington Regional Hospital /ID# 229490	Newtown	Wellington	New Zealand	6021
95	CGM Research Trust /ID# 244893	Christchurch Central		New Zealand	8011
96	Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o /ID# 228357	Wroclaw	Dolnoslaskie	Poland	53-224
97	Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 228353	Bydgoszcz	Kujawsko-pomorskie	Poland	85-168
98	Centrum Medyczne Reuma Park /ID# 244813	Warszawa	Mazowieckie	Poland	02-665
99	Nova Reuma Domyslawska I Rusilowicz - Spolka Partnerska Lekarza Reumatologa I Fi /Id# 228466	Bialystok	Podlaskie	Poland	15-707
100	AI Centrum Medyczne Sp. z o.o. sp.k. /ID# 228951	Poznan	Wielkopolskie	Poland	61-113
101	Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 228314	Poznan	Wielkopolskie	Poland	61-545
102	Hospital Clínico Universitario de Santiago-CHUS /ID# 244868	Santiago de Compostela	A Coruna	Spain	15706
103	Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 244866	Sabadell	Barcelona	Spain	08208
104	Hospital Unversitario Marques de Valdecilla /ID# 229297	Santander	Cantabria	Spain	39008
105	Hospital Universitario Canarias /ID# 229451	San Cristóbal de La Laguna	Santa Cruz De Tenerife	Spain	38320
106	Hospital Clinic de Barcelona /ID# 229295	Barcelona		Spain	08036
107	Hospital General Universitario Gregorio Maranon /ID# 229302	Madrid		Spain	28007
108	Hospital Clinico Universitario San Carlos /ID# 229296	Madrid		Spain	28040
109	North West Anglia NHS Foundation Trust /ID# 230866	Bretton	Cambridgeshire	United Kingdom	PE3 9GZ
110	Leicester Royal Infirmary /ID# 231967	Leicester	England	United Kingdom	LE1 5WW
111	The Royal Free London NHS Foundation Trust /ID# 231707	London	London, City Of	United Kingdom	NW3 2QG
112	Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 231966	Norwich	Norfolk	United Kingdom	NR4 7UY
113	Cardiff & Vale University Health Board /ID# 245297	Cardiff	Wales	United Kingdom	CF14 4XN
114	UH Coventry & Warwickshire /ID# 228588	Coventry		United Kingdom	CV2 2DX
115	NHS Lothian /ID# 245293	Edinburgh		United Kingdom	EH3 9HE
116	Liverpool University Hospitals NHS Foundation Trust /ID# 245296	Liverpool		United Kingdom	L7 8XP
117	Manchester University NHS Foundation Trust /ID# 230886	Manchester		United Kingdom	M13 9WL
118	Portsmouth Hospitals University NHS Trust /ID# 245291	Portsmouth		United Kingdom	PO6 3LY
119	The Royal Wolverhampton NHS Trust /ID# 230302	Wolverhampton		United Kingdom	WV10 0QP