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

NCT ID: NCT05087030

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 473 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-21
• Study Completion Date: 2023-11-15

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

RGB-14-P

Intervention Type: DRUG

Participants will receive RGB-14-P into the thigh, abdomen, or upper arm as per the arm assigned.

Prolia® (Main period)

Randomized participants will receive SC injection of Prolia®, on Day 1 of Treatment periods 1 and 2.

Group Type: ACTIVE_COMPARATOR

Prolia®

Intervention Type: DRUG

Participants will receive Prolia® into the thigh, abdomen, or upper arm as per the arm assigned.

RGB-14-P (Transition period)

Re-randomized participants will receive SC injection of RGB-14-P, on Day 1 of Treatment period 3.

Group Type: EXPERIMENTAL

RGB-14-P

Intervention Type: DRUG

Participants will receive RGB-14-P into the thigh, abdomen, or upper arm as per the arm assigned.

Prolia® (Transition period)

Re-randomized participants will receive SC injection of Prolia®, on Day 1 of Treatment period 3.

Group Type: ACTIVE_COMPARATOR

Prolia®

Intervention Type: DRUG

Participants will receive Prolia® into the thigh, abdomen, or upper arm as per the arm assigned.

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.

Group Type: EXPERIMENTAL

RGB-14-P

Intervention Type: DRUG

Participants will receive RGB-14-P into the thigh, abdomen, or upper arm as per the arm assigned.

Interventions

RGB-14-P

Participants will receive RGB-14-P into the thigh, abdomen, or upper arm as per the arm assigned.

Intervention Type: DRUG

Prolia®

Participants will receive Prolia® into the thigh, abdomen, or upper arm as per the arm assigned.

Intervention Type: DRUG

Eligibility 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 osteonecrosis of the jaw (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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gedeon Richter Plc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Miami Clinical Research

Miami, Florida, United States

Global Health Research Center

Miami Lakes, Florida, United States

iResearch Atlanta, LLC

Decatur, Georgia, United States

Excel Clinical Research - Internal Medicine

Las Vegas, Nevada, United States

Medical Center Hera EOOD - Rheumatology Office

Sofia, Sofia-Grad, Bulgaria

Medical Center Medconsult Pleven

Pleven, , Bulgaria

UMHAT Kaspela

Plovdiv, , Bulgaria

DKC "Sveti Georgi"

Plovdiv, , Bulgaria

UMHAT Kaspela (Endocrinology/metabolic disease)

Plovdiv, , Bulgaria

UMHAT Pulmed - Reumathology

Plovdiv, , Bulgaria

UMHAT Plovdiv

Plovdiv, , Bulgaria

Medical Center - Teodora EOOD

Rousse, , Bulgaria

Medical Center Excelsior

Sofia, , Bulgaria

"DCC XVII-Sofia" EOOD

Sofia, , Bulgaria

APAVAR Lekarna

Ostrava, Ostrava-město, Czechia

FN Hradec Kralove

Hradec Králové, , Czechia

Klatovska nemocnice, a.s.

Klatovy, , Czechia

Fakultni nemocnice Plzen

Pilsen, , Czechia

Revmatologicky ustav

Prague, , Czechia

Affidea Praha s.r.o.

Prague, , Czechia

Fakultni nemocnice v Motole

Prague, , Czechia

BAZM KKH EOK Szt Ferenc Tagkh

Miskolc, Borsod-Abauj Zemplen county, Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hajdú-Bihar, Hungary

Qualiclinic Kft.

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Pest Megyei Flor Ferenc Korhaz

Kistarcsa, , Hungary

Csongrad Megyei Dr Bugyi Istvan Korhaz

Szentes, , Hungary

IRCCS Policlinico San Matteo, Università degli studi di Pavi

Pavia, , Italy

Azienda Ospedaliera di Perugia - Ospedale Santa Maria della

Perugia, , Italy

Azienda Ospedaliero Universitaria Integrata Verona

Veneto, , Italy

Barbara Rewerska Diamond Clin.

Krakow, Lesser Poland Voivodeship, Poland

Zespol Poradni Specjalistycznych REUMED, Filia nr 1 Wallenroda

Lublin, Lublin Voivodeship, Poland

Lubelskie Centrum Diagnostyczne

Świdnik, Lublin Voivodeship, Poland

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, Masovian Voivodeship, Poland

Komisja Bioetyczna przy OIL w Bialymstoku

Bialystok, Podlaskie Voivodeship, Poland

Nasz Lekarz Osrodek Badan Klinicznych

Bialystok, Podlaskie Voivodeship, Poland

ClinicMed Daniluk, Nowak Sp. J

Bialystok, Podlaskie Voivodeship, Poland

Nasz Lekarz Osrodek Badan Klinicznych

Bydgoszcz, , Poland

Centrum Medyczne Pratia Gdynia

Gdynia, , Poland

Centrum Medyczne Pratia Katowice

Katowice, , Poland

Centrum Medyczne Plejady

Krakow, , Poland

Oswiecimskie Centrum Badan Klinicznych

Oświęcim, , Poland

RCMed Oddzial Sochaczew

Sochaczew, , Poland

RCMed

Sochaczew, , Poland

Medycyna Kliniczna

Warsaw, , Poland

RCMed Oddział Warszawa

Warsaw, , Poland

Centrum Medyczne Reuma Park

Warsaw, , Poland

H. Ntra. Sra. de la Esperanza

Santiago de Compostela, A Coruña, Spain

Corporacio Sanitaria Parc Tauli de Sabadell - Servicio de reumatologia

Sabadell, Barcelona, Spain

Complejo Hospitalario Universitario A Coruña

A Coruña, , Spain

Hospital de La Santa Creu i Sant Pau

Barcelona, , Spain

Centro Medico Instituto Palacios

Madrid, , Spain

Clinica Gaias Santiago

Santiago de Compostela, , Spain

Medychnyi tsentr tovarystva z obmezhenoyu vidpovidalnistyu "Medbud-Klinik"

Kyiv, Kyïv, Ukraine

Derzhavna ustanova "Instytut herontolohii imeni D.F. Chebotarova Natsionalnoi akademii medychnykh nauk Ukrainy

Kyiv, Kyïv, Ukraine

Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova

Vinnytsia, Vinnytsia Oblast, Ukraine

Naukovo-doslidnyi instytut reabilitatsii osib z invalidnistiu (navchalno-naukovo-likuvalnyi kompleks) Vinnytskoho natsionalnoho medychnoho universytetu im. M.I. Pyrohova

Vinnytsia, Vinnytsia Oblast, Ukraine

Kyivska klinichna likarnia na zaliznychnomu transporti #2 filii "Tsentr okhorony zdoroviya" AT "Ukrayinska Zaliznytsia"

Kiyiv, , Ukraine

Med tsentr TOV "Tsentr simeinoi medytsyny plius"

Kiyiv, , Ukraine

Countries

United States; Bulgaria; Czechia; Hungary; Italy; Poland; Spain; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020 006017 38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RGB 14 101

Identifier Type: -

Identifier Source: org_study_id