NCT05087030

Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis

A Randomised, Double Blind, Multicentre Phase III Study to Assess the Efficacy and Safety of RGB-14-P Compared to Prolia® in Women With Postmenopausal Osteoporosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 473 (actual)
• Sponsor: Gedeon Richter Plc. · Industry
• Sex: Female
• Age: 60 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted to assess the efficacy, pharmacodynamic (PD), safety, tolerability, and immunogenicity of RGB -14- P compared to US-licensed Prolia® in participants with postmenopausal osteoporosis, in a comparative manner.

Detailed description

This is a randomized, double-blind, multicentre, multiple fixed-dose, 2-arm parallel-group study that includes 2 periods as: 1. Main period (52 weeks), consists of Treatment Period 1 (26 weeks) and Treatment Period 2 (26 weeks). On Day 1 of Treatment Period 1, prior to dosing, participants will be randomized in a 1:1 ratio to receive either RGB-14-P or Prolia®. 2. Transition Period: consists of Treatment Period 3 (26 weeks). On Day 1 of Treatment Period 3 (Week 52), a subset of participants who received Prolia® during the Main Period will be re-randomized 1:1 to receive either a dose RGB-14-P or Prolia® in a double-blinded manner. A subset of participants continuing in the Transition Period who received RGB-14-P during the Main Period will continue to receive a dose of RGB-14- P but will also follow the randomization procedure to maintain blinding. All participants will receive the study drugs on 2 occasions (Weeks 0 and 26), on Day 1 of Treatment Periods 1 and 2. Participants continuing to the Transition Period will receive the study drugs on a third-occasion (Week 52), Day 1 of Treatment Period 3. One Treatment Period will take 6 months (26 weeks, 183 days).

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	RGB-14-P	Participants will receive RGB-14-P into the thigh, abdomen, or upper arm as per the arm assigned.
DRUG	Prolia®	Participants will receive Prolia® into the thigh, abdomen, or upper arm as per the arm assigned.

Timeline

• Start date: 2021-09-21
• Primary completion: 2023-10-02
• Completion: 2023-11-15
• First posted: 2021-10-21
• Last updated: 2024-10-24
• Results posted: 2024-10-24

Locations

59 sites across 8 countries: United States, Bulgaria, Czechia, Hungary, Italy, Poland, Spain, Ukraine

Regulatory

• FDA-regulated drug study