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 (AIM-PMR)

AbbVie

Status and phase: Terminated; Phase 2

Conditions: Polymyalgia Rheumatica

Treatments: Drug: Placebo; Drug: Glucocorticoid; Drug: ABBV-154

Study type: Interventional

Funder types: Industry

Identifiers

NCT04972968

2021-000648-23 (EudraCT Number)

M20-370

Details and patient eligibility

About

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.

Enrollment: 181 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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181 participants in 4 patient groups, including a placebo group

ABBV-154 Dose A

Experimental group

Description:

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.

Treatment:

Drug: ABBV-154

Drug: Glucocorticoid

ABBV-154 Dose B

Experimental group

Description:

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.

Treatment:

Drug: ABBV-154

Drug: Glucocorticoid

ABBV-154 Dose C

Experimental group

Description:

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.

Treatment:

Drug: ABBV-154

Drug: Glucocorticoid

Placebo

Placebo Comparator group

Description:

Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.

Treatment:

Drug: Glucocorticoid

Drug: Placebo