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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Polymyalgia Rheumatica

In brief

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.

Key facts

Study ID

NCT04972968

Run by

AbbVie

People needed

181

Starts

2021-09-09

Expected to finish

2023-07-24

Last updated by the study team

2024-10-15

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Providence Medical Foundation /ID# 228681 — Fullerton, California, United States
• Care Access Research, Huntington Beach /ID# 228677 — Huntington Beach, California, 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
• Hans Richard Barthel, M.D., Inc /ID# 231902 — Santa Barbara, California, United States
• Medvin Clinical Research /ID# 228675 — Tujunga, California, United States
• Inland Rheum & Osteo Med Grp /ID# 228679 — Upland, California, United States
• Denver Arthritis Clinic /ID# 245736 — Denver, Colorado, United States
• Delaware Arthritis /ID# 230110 — Lewes, Delaware, United States
• Arthritis & Rheumatic Disease Specialties /ID# 245448 — Aventura, Florida, 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
• Lakes Research, LLC /ID# 228757 — Miami, Florida, United States
• HMD Research LLC /ID# 228767 — Orlando, Florida, United States
• Springfield Clinic /ID# 228840 — Springfield, Illinois, United States
• Four Rivers Clinical Research /ID# 228858 — Paducah, Kentucky, United States
• Rheumatology Consultants - Clinical Research /ID# 232137 — Tupelo, Mississippi, United States
• Dartmouth-Hitchcock Medical Center /ID# 229557 — Lebanon, New Hampshire, United States
• Ocean Rheumatology, PA /ID# 232539 — Toms River, New Jersey, United States
• Hospital for Special Surgery /ID# 228577 — New York, New York, 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
• Paramount Medical Research Con /ID# 228839 — Middleburg Heights, Ohio, United States
• Arthritis and Rheumatism Associates /ID# 232089 — Jonesboro, Arkansas, United States

Full record on ClinicalTrials.gov

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