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The objectives of this study are to assess the safety, effectiveness, and immunogenicity of AA4500 in the treatment of adhesive capsulitis.
Full description
Study is a Phase 2b, double-blind, placebo-controlled study of the safety and efficacy of AA4500 for the treatment of adhesive capsulitis of the shoulder. To be eligible for treatment, a subject must have unilateral idiopathic adhesive capsulitis of the shoulder with restricted range of motion in the affected shoulder for at least 3 months but not more than 12 months. Subjects will be screened for study eligibility within 28 days before injection of study drug.
Approximately 300 adult women and men are to be enrolled in this study. Following screening and determination of study eligibility, subjects will be randomized 3:1 to receive 0.58 mg of AA4500 or placebo. Subjects will receive up to 3 injections of study drug. Each injection will be separated by a minimum of 21 days. Subjects will also be instructed in home shoulder exercises after the first injection.
Enrollment
Sex
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Volunteers
Inclusion criteria
Unilateral idiopathic adhesive capsulitis of one shoulder for at least 3 months but not more than 12 months (Frozen Stage)
Normal range of motion in the contralateral shoulder
Restricted active range of motion (AROM) in the affected shoulder defined as: a deficit of at least 60 degrees in total AROM in the affected shoulder as compared with the total AROM in the contralateral shoulder and a deficit of at least 30 degrees in AROM in at least one of the following planes as compared with the contralateral shoulder:
Exclusion criteria
Has received treatment for adhesive capsulitis or is planning to receive treatment for adhesive capsulitis at any time during the study including but not limited to:
Has any of the following conditions, as determined by investigator to be potentially confounding to the evaluation of safety and efficacy:
Has received oral or intravenous steroids for any reason within 3 weeks before the screening visit
Has received an investigational drug or treatment within 30 days before the first dose of study drug.
Has a known allergy to collagenase or any other excipient of AA4500 or any other procedural medication.
Has, at any time, received collagenase for the treatment of adhesive capsulitis.
Is unable to undergo an x-ray or MRI (contraindication) evaluation of the affected shoulder.
Is planning to be treated with commercial XIAFLEX at any time during the study.
Primary purpose
Allocation
Interventional model
Masking
322 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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