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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

Phase 2
Terminated
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
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboGlucocorticoidParticipants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
ABBV-154 Dose BABBV-154Participants 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 BGlucocorticoidParticipants 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 AGlucocorticoidParticipants 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.
PlaceboPlaceboParticipants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
ABBV-154 Dose CABBV-154Participants 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 AABBV-154Participants 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 CGlucocorticoidParticipants 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
NameTimeMethod
Time to FlareFrom 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
NameTimeMethod
Percentage of Participants Achieving Flare-Free StateUp to Week 24

Percentage of participants achieving flare-free state.

Cumulative Glucocorticoid DoseWeek 24

Cumulative glucocorticoid dose.

Change From Baseline in Glucocorticoid DoseWeek 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

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Kistarcsai Flor Ferenc Korhaz /ID# 229676
🇭🇺Kistarcsa, Hungary

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