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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

1. Adults at least 50 years of age with a clinical diagnosis of PMR and
fulfillment of the 2012 EULAR/ACR provisional classification criteria for PMR.
2. Following a confirmed diagnosis of PMR, subject must have shown a clinical
response to prednisone (or equivalent).
3. Subject must have had at least 2 episodes of unequivocal PMR flare while
attempting to taper prednisone, with the dose of prednisone (or equivalent) at
the time of flare >= 5 mg/day, prior to Baseline; the most recent flare must
have been within 24 weeks of Baseline. Unequivocal PMR flare is defined as
clinical signs and symptoms of PMR (shoulder and/or hip girdle pain with
inflammatory stiffness, neck pain with inflammatory stiffness, or new or
worsened limited range of motion of hips and/or shoulders) that resulted in an
increase in glucocorticoid dose.
4. Subject must be on a stable prednisone (or equivalent) dose of 5 to 15
mg/day for >= 2 weeks prior to Baseline. Subjects may be on up to 25 mg/day at
the Screening Visit provided that the subject is able to taper to 15 mg/day or
less, with a stable dose >= 2 weeks prior to Baseline.
5. Subject must be willing to follow the protocol-defined glucocorticoid
tapering regimen.

Exclusion Criteria

1. Subject must have discontinued use of immunomodulators other than prednisone
(or equivalent) and hydroxychloroquine prior to Baseline.
2. Subjects requiring > 25 mg/day of prednisone to control confirmed PMR are
excluded
3. Subject must not exhibit clinical signs and symptoms of PMR (shoulder and/or
hip girdle pain with inflammatory stiffness, neck pain with inflammatory
stiffness, or new or worsened limited range of motion of hips and/or shoulders)
within 2 weeks of Baseline

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Time to flare, where flare is defined as follows:<br /><br>• Presence of clinical signs and symptoms of PMR<br /><br>AND<br /><br>• Requirement to increase the glucocorticoid dose per investigator.<br /><br>Clinical signs and symptoms of PMR are defined as shoulder and/or hip girdle<br /><br>pain with inflammatory stiffness, neck pain with inflammatory stiffness, or new<br /><br>or worsened limited range of motion of hips and/or shoulders that are not due<br /><br>to other causes<br /><br><br /><br>Timepoint of evaluation: week 24</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Achievement of flare-free state up to Week 24<br /><br>• Cumulative glucocorticoid dose by 24 weeks<br /><br>• Change from Baseline in glucocorticoid dose at Week 24</p><br>