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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Polymyalgia Rheumatica

Intervention / Treatment
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* Drug: ABBV-154
* Drug: Placebo
* Drug: Glucocorticoid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABBV-154 Dose A<br>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<br>* Subcutaneous Injection<br>Drug: Glucocorticoid<br>* Oral Tablet<br>|
| Experimental: ABBV-154 Dose B<br>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<br>* Subcutaneous Injection<br>Drug: Glucocorticoid<br>* Oral Tablet<br>|
| Experimental: ABBV-154 Dose C<br>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<br>* Subcutaneous Injection<br>Drug: Glucocorticoid<br>* Oral Tablet<br>|
| Placebo Comparator: Placebo<br>Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper. | Drug: Placebo<br>* Subcutaneous Injection<br>Drug: Glucocorticoid<br>* Oral Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Flare | Flare is defined as, presence of clinical signs and symptoms of PMR and requirement to increase the glucocorticoid dose per investigator. | Up to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Flare-Free State | Percentage of participants achieving flare-free state. | Up to Week 24 | 
| Cumulative Glucocorticoid Dose | Cumulative glucocorticoid dose. | Week 24 | 
| Change from Baseline in Glucocorticoid Dose | Change from Baseline in glucocorticoid dose. | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PMR, Polymyalgia Rheumatica, ABBV-154, Glucocorticoid