EUCTR2021-000648-23-ATActive, not recruitingPhase 1
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluatethe Safety and Efficacy of ABBV-154 in Subjects with Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment - A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of ABBV-154
AbbVie Deutschland GmbH & Co. KG0 sites181 target enrollmentStarted: September 21, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 181
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 37
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 144
Exclusion Criteria
- •1. Subject must have discontinued use of immunomodulators other than prednisone (or equivalent) and hydroxychloroquine prior to Baseline.
- •2. 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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