NL-OMON54200CompletedPhase 2
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 - M20-370
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 15
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •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
Investigators
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