This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment
- Conditions
- Subjects with Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid TreatmentMedDRA version: 21.0Level: PTClassification code 10036099Term: Polymyalgia rheumaticaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2021-000648-23-DE
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 160
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.
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 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 128
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the safety and efficacy of ABBV-154 versus placebo in subjects with PMR, who are dependent on treatment with glucocorticoids with doses of at least 5 mg/day prednisone equivalent (glucocorticoid-dependent PMR).;Secondary Objective: To assess the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ABBV-154.;Primary end point(s): Time to flare, where flare is defined as follows:<br>• Presence of clinical signs and symptoms of PMR<br>AND<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 pain with inflammatory stiffness, neck pain with inflammatory stiffness, or new or worsened limited range of motion of hips and/or shoulders that are not due to other causes;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Achievement of flare-free state up to Week 24<br>• Cumulative glucocorticoid dose by 24 weeks<br>• Change from Baseline in glucocorticoid dose at Week 24;Timepoint(s) of evaluation of this end point: Week 24