Trial record 1 of 1 for:
RGB-14-P
Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05087030 |
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Recruitment Status :
Active, not recruiting
First Posted : October 21, 2021
Last Update Posted : November 27, 2023
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Sponsor:
Gedeon Richter Plc.
Information provided by (Responsible Party):
Gedeon Richter Plc.
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Postmenopausal Osteoporosis | Drug: RGB-14-P Drug: Prolia® | Phase 3 |
This is a randomized, double-blind, multicentre, multiple fixed-dose, 2-arm parallel-group study that includes 2 periods as:
- 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®.
- 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).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 473 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Care Provider) |
| Masking Description: | A double-blind design will be used during the main and transition periods. |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | September 21, 2021 |
| Estimated Primary Completion Date : | November 15, 2023 |
| Estimated Study Completion Date : | November 15, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Osteoporosis
Drug Information
available for:
Denosumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: RGB-14-P (Main period)
Randomized participants will receive subcutaneous (SC) injection of RGB-14-P, on Day 1 of Treatment periods 1 and 2.
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Drug: RGB-14-P
Participants will receive RGB-14-P into the thigh, abdomen, or upper arm as per the arm assigned. |
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Active Comparator: Prolia® (Main period)
Randomized participants will receive SC injection of Prolia®, on Day 1 of Treatment periods 1 and 2.
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Drug: Prolia®
Participants will receive Prolia® into the thigh, abdomen, or upper arm as per the arm assigned. |
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Experimental: RGB-14-P (Transition period)
Re-randomized participants will receive SC injection of RGB-14-P, on Day 1 of Treatment period 3.
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Drug: RGB-14-P
Participants will receive RGB-14-P into the thigh, abdomen, or upper arm as per the arm assigned. |
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Active Comparator: Prolia® (Transition period)
Re-randomized participants will receive SC injection of Prolia®, on Day 1 of Treatment period 3.
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Drug: Prolia®
Participants will receive Prolia® into the thigh, abdomen, or upper arm as per the arm assigned. |
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Experimental: RGB-14-P (Continued till transition period)
Randomized participants will continue to receive SC injection of RGB-14-P from the main period till Day 1 of Treatment period 3.
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Drug: RGB-14-P
Participants will receive RGB-14-P into the thigh, abdomen, or upper arm as per the arm assigned. |
Primary Outcome Measures :
- Percentage change from baseline in lumbar spine bone mineral density (BMD) [ Time Frame: Baseline, Week 52 ]Efficacy and effect similarity of RGB-14- P with US-licensed Prolia® on BMD at the lumbar spine at Week 52 will be determined in female participants with postmenopausal osteoporosis.
- Area under the effective curve after the first dose until Day 183 of percentage change from baseline in serum type I collagen C-telopeptide up to month 6 (AUEC of %CfB in sCTX00-m6) until Week 26 [ Time Frame: Baseline, until Week 26 (Predose) ]Similar pharmacodynamics (AUEC of %CfB in sCTX) of RGB-14-P with US-licensed Prolia® in female participants will be demonstrated with postmenopausal osteoporosis.
Secondary Outcome Measures :
- Percentage change from baseline in total hip BMD [ Time Frame: Baseline, Weeks 26, 52 and 78 ]Additional comparative efficacy data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis.
- Percentage change from baseline in lumbar spine BMD [ Time Frame: Baseline, Weeks 26 and 78 ]Additional comparative efficacy data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis.
- Percentage change from baseline in femoral neck BMD [ Time Frame: Baseline, Weeks 26, 52 and 78 ]Additional comparative efficacy data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis.
- Vertebral fragility fracture incidence [ Time Frame: Weeks 52 and 78 ]Additional comparative efficacy data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis.
- Non-vertebral fragility fracture incidence [ Time Frame: Weeks 52 and 78 ]Additional comparative efficacy data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis.
- Percentage change from baseline in serum procollagen type 1 N terminal propeptide (P1NP) [ Time Frame: Baseline, Weeks 4, 26, 52 and 78 ]Additional comparative pharmacodynamic data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis.
- Percentage change from baseline in serum type I collagen C-telopeptide (sCTX) [ Time Frame: Baseline, Weeks 4, 26, 52 and 78 ]Additional comparative pharmacodynamic data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis.
- Number of participants with adverse events (AEs) [ Time Frame: From Screening (Weeks -5 to 0) until Week 78 ]The safety and tolerability of RGB-14-P with US-licensed Prolia® will be compared in female participants with postmenopausal osteoporosis will be compared.
- Number of participants with anti-drug antibodies (ADAs) and neutralizing antibodies [ Time Frame: Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78 ]The immunogenicity of RGB -14- P with US-licensed Prolia® in female participants with postmenopausal osteoporosis will be compared.
- Titre of ADAs against RGB-14-P [ Time Frame: Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78 ]The immunogenicity of RGB -14- P with US-licensed Prolia® in female participants with postmenopausal osteoporosis will be compared.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 60 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participant is an ambulatory postmenopausal woman, diagnosed with osteoporosis, able to walk, and not bedridden
- Participant has an absolute BMD consistent with T score ≤ 2.5 and ≥ 4.0 at the lumbar spine as measured by dual-energy X-ray absorptiometry (DXA) during the Screening Period and at least 2 lumbar vertebrae (from L1 to L4) must be evaluable by DXA
- Participant has body weight ≥ 50 and ≤ 90 kg at the Screening Period
Participants must meet the following criteria to be enrolled in the Transition Period:
- Have been enrolled, received both doses of the test drug, and completed the scheduled Main Period (up to Week 52) of the RGB-14-101 study
Exclusion Criteria:
- Participant has a history and/or presence of a severe or more than two moderate vertebral fractures as determined by central reading of lateral spine X-ray during the Screening Period
- Participant has a history and/or presence of hip fracture
- Participant has a history and/or presence of atypical femur fracture
- Participant presents with an active healing fracture
- Participant has a bilateral hip replacement (unilateral is allowed if the other hip is evaluable with DXA)
- Participant has a vitamin D deficiency
- Participant has hypocalcaemia or hypercalcemia at the Screening Period
- Participant has a history and/or presence of bone metastases, renal osteodystrophy, osteomyelitis, any metabolic, endocrine or traumatic bone disease
- Participant has a current uncontrolled status of hypothyroidism or hyperthyroidism
- Participant has a history (within 5 years prior to Screening) and/or current hypoparathyroidism or hyperparathyroidism
- Participant has malignancy within 5 years before Screening
- Participant has a history and/or presence of significant cardiac disease
- Participant has a known intolerance or malabsorption of calcium or vitamin D supplements
- Participant shows contraindications to denosumab therapy (e.g., hypocalcaemia), or calcium or vitamin D supplementation before starting test drug administration
- Participant has a latex allergy
- Participant has a history and/or presence of ONJ or risk factors for ONJ such as invasive dental procedures
- Participant has history and/or presence of osteonecrosis of the external auditory canal
- Participant requiring ongoing use of any osteoporosis treatment
- Participant has previously received denosumab or biosimilar denosumab
- Participant has weight or girth measurements which may preclude accurate DXA measurements
- Participant has an active infection, including, but not limited to severe acute respiratory syndrome coronavirus-2, hepatis B, hepatitis C and human immunodeficiency virus infections during the Screening Period
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05087030
Locations
Show 59 study locations
Sponsors and Collaborators
Gedeon Richter Plc.
| Responsible Party: | Gedeon Richter Plc. |
| ClinicalTrials.gov Identifier: | NCT05087030 |
| Other Study ID Numbers: |
RGB 14 101 2020 006017 38 ( EudraCT Number ) |
| First Posted: | October 21, 2021 Key Record Dates |
| Last Update Posted: | November 27, 2023 |
| Last Verified: | November 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Gedeon Richter Plc.:
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Biosimilars Prolia® |
Additional relevant MeSH terms:
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Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Metabolic Diseases Denosumab Bone Density Conservation Agents Physiological Effects of Drugs |