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-IT
- Lead Sponsor
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
1. Adults 50 – 80 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 dose) of 5 to 25 mg/day.
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150
1. Subject must have discontinued use of immunomodulators other than prednisone (or equivalent) 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 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