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
- Conditions
- Polymyalgia Rheumatica
- Interventions
- Registration Number
- NCT04972968
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 181
- 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.
- Have been treated with a prior TNF antagonist.
- Current use of immunomodulators other than prednisone and hydroxychloroquine.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Glucocorticoid Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper. ABBV-154 Dose B ABBV-154 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. ABBV-154 Dose B Glucocorticoid 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. ABBV-154 Dose A Glucocorticoid 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. Placebo Placebo Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper. ABBV-154 Dose C ABBV-154 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. ABBV-154 Dose A ABBV-154 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. ABBV-154 Dose C Glucocorticoid 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.
- Primary Outcome Measures
Name Time Method Time to Flare From first dose of study drug 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
Name Time Method 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.
Trial Locations
- Locations (117)
Kistarcsai Flor Ferenc Korhaz /ID# 229676
🇭🇺Kistarcsa, Hungary
Kuwana city medical center /ID# 231936
🇯🇵Kuwana-shi, Mie, Japan
Hospital Universitario Marques de Valdecilla /ID# 229297
🇪🇸Santander, Cantabria, Spain
Arthritis and Rheumatism Associates /ID# 232089
🇺🇸Jonesboro, Arkansas, United States
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
Scroll for more (107 remaining)Kistarcsai Flor Ferenc Korhaz /ID# 229676🇭🇺Kistarcsa, Hungary