A Randomized, Double-Blind, Parallel Design, Repeat Dose, 2-arm, Multicenter Study Comparing the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profiles of AVT03 and US-Prolia® in Postmenopausal Women With Osteoporosis, ALVOBOND
Overview
- Phase
- Phase 3
- Intervention
- AVT03
- Conditions
- Osteoporosis, Postmenopausal
- Sponsor
- Alvotech Swiss AG
- Enrollment
- 532
- Locations
- 34
- Primary Endpoint
- Percent Change From Baseline in LS BMD at Month 12 to Demonstrate Comparable Efficacy of AVT03 and Prolia®.
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
This is a randomized, double-blind, parallel design, repeat dose, 2 arm, multicenter study comparing the efficacy, safety, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of AVT03 and US-Prolia in postmenopausal women with osteoporosis.
Detailed Description
After the screening activities, eligible subjects were randomized to receive either AVT03 60 mg or Prolia® 60 mg, administered as a subcutaneous (s.c.) injection on Day 1 and at Month 6. At Month 12, subjects in AVT03 treatment group will received a third dose of AVT03 60 mg administered s.c. while subjects in Prolia® treatment group will were be re-randomized 1:1 to receive either Prolia 60 mg or AVT03 60 mg administered as a subcutaneous injection. Afterwards, the subjects will be followed until the End of Study (EoS) Visit.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
AVT03
AVT03 is the proposed biosimilar for Prolia.
Intervention: AVT03
Prolia
Intervention: Denosumab
Outcomes
Primary Outcomes
Percent Change From Baseline in LS BMD at Month 12 to Demonstrate Comparable Efficacy of AVT03 and Prolia®.
Time Frame: Baseline to Month 12
Percent Change From Baseline in LS BMD at Month 12 to demonstrate comparable efficacy of AVT03 and Prolia®.
To Demonstrate Comparable Profile of AVT03 and Prolia in Terms of Area Under the Percent Change From Baseline in Serum C-telopeptide of Type 1 Collagen (AUEC of %Cfb sCTX-1)
Time Frame: Baseline to Month 6
Secondary Outcomes
- Frequency and Severity of Findings in Routine Safety Parameters(Month 18)
- Frequency and Severity of Injection Site Reactions(Month 12)
- Percent Change From Baseline in Hip and Femoral Neck BMD(Month 6, Month 12, Month 18)
- Incidence of New Morphometric Vertebral Fractures(Month 12 and 18)
- Percent Change From Baseline in sCTX-1(Month 3, Month 6, Month 9, Month 12 and Month 18)
- Incidence, Nature and Severity of Adverse Events Including Adverse Drug Reactions(Month 18)
- Frequency and Titer of Anti-drug Antibodies and Frequency of Neutralizing Antibodies Against AVT03 and Prolia(Month 18)
- Serum Trough Concentration of AVT03 and Prolia(Month 18)
- Percent Change From Baseline in LS BMD(Month 6, Month18)