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Monoclonal Antibodies
RGB-14-P + Prolia® for Osteoporosis
Phase 3
Waitlist Available
Research Sponsored by Gedeon Richter Plc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing a new drug, RGB-14-P, against an existing drug, Prolia®, in postmenopausal women with osteoporosis. The goal is to see if RGB-14-P is as effective as Prolia® in strengthening bones by slowing down bone breakdown. Prolia® is already approved for treating postmenopausal osteoporosis in women at high risk of fractures.
Eligible Conditions
- Osteoporosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Area Under the Effective Curve (AUEC) After the First Dose Until Day 183 of %CfB in Serum Type I Collagen C-telopeptide (sCTX)
Percentage Change From Baseline (%CfB) in Lumbar Spine Bone Mineral Density (BMD)
Secondary study objectives
%CfB in Femoral Neck BMD
%CfB in Lumbar Spine BMD
%CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP)
+8 moreSide effects data
From 2023 Phase 3 trial • 473 Patients • NCT050870306%
Nasopharyngitis
3%
Hypocalcaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Transition Period: Prolia® to Prolia®
Transition Period: RGB-14-P to RGB-14-P
Transition Period: Prolia® to RGB-14-P
Main Period: RGB-14-P
Main Period: Prolia®
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: RGB-14-P (Transition period)Experimental Treatment1 Intervention
Re-randomized participants will receive SC injection of RGB-14-P, on Day 1 of Treatment period 3.
Group II: RGB-14-P (Main period)Experimental Treatment1 Intervention
Randomized participants will receive subcutaneous (SC) injection of RGB-14-P, on Day 1 of Treatment periods 1 and 2.
Group III: RGB-14-P (Continued till transition period)Experimental Treatment1 Intervention
Randomized participants will continue to receive SC injection of RGB-14-P from the main period till Day 1 of Treatment period 3.
Group IV: Prolia® (Main period)Active Control1 Intervention
Randomized participants will receive SC injection of Prolia®, on Day 1 of Treatment periods 1 and 2.
Group V: Prolia® (Transition period)Active Control1 Intervention
Re-randomized participants will receive SC injection of Prolia®, on Day 1 of Treatment period 3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RGB-14-P
2021
Completed Phase 3
~480
Find a Location
Who is running the clinical trial?
Gedeon Richter Plc.Lead Sponsor
11 Previous Clinical Trials
3,203 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of serious heart problems or currently have a heart condition.You are allergic to latex.You have experienced or currently have a type of leg fracture called "atypical femur fracture".Your thyroid condition is not currently well-controlled.You have had or currently have problems with your parathyroid gland within the past 5 years.You cannot tolerate or properly absorb calcium or vitamin D supplements.You have a history or currently have a condition called osteonecrosis of the external auditory canal, which affects the ear canal.You have had a condition called ONJ (osteonecrosis of the jaw) before or have risk factors for developing it, like having invasive dental procedures.You are currently taking medicine for osteoporosis.You have previously broken your hip or currently have a broken hip.You have taken denosumab or a similar medication before.You have a broken bone that is still in the process of healing.You have a history of bone problems like fractures or infections, or currently have bone metastases or diseases affecting your bones.
Research Study Groups:
This trial has the following groups:- Group 1: RGB-14-P (Main period)
- Group 2: Prolia® (Main period)
- Group 3: RGB-14-P (Transition period)
- Group 4: Prolia® (Transition period)
- Group 5: RGB-14-P (Continued till transition period)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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