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

NCT05087030 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: RGB 14 1012020 006017 38
• Study Type: interventional
• Target: 473
• Locations: 8 countries
• Sites: 59

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.

Conditions

Postmenopausal Osteoporosis

Keywords

Biosimilars; Prolia®

Outcome Measures

Primary Outcomes (2)

• Percentage Change From Baseline (%CfB) in Lumbar Spine Bone Mineral Density (BMD)

  Percentage change from baseline in lumbar bone BMD was assessed. BMD at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA). This outcome measure was assessed for main period.

  Week 52

• Area Under the Effective Curve (AUEC) After the First Dose Until Day 183 of %CfB in Serum Type I Collagen C-telopeptide (sCTX)

  The AUEC of %CfB in sCTX of RGB-14-P was assessed as part of pharmacodynamics parameter with US-licensed Prolia® in female participants was demonstrated with postmenopausal osteoporosis. This outcome measure was assessed for main period only.

  Week 26

Secondary Outcomes (11)

• %CfB in Total Hip BMD

  Weeks 26, 52 and 78

• %CfB in Lumbar Spine BMD

  Weeks 26 and 78

• %CfB in Femoral Neck BMD

  Weeks 26, 52 and 78

• Number of Participants With Vertebral Fragility Fracture

  Weeks 52 and 78

• Number of Participants With Non-vertebral Fragility Fracture

  Weeks 52 and 78

Study Arms (5)

RGB-14-P (Main period)

EXPERIMENTAL

Randomized participants will receive subcutaneous (SC) injection of RGB-14-P, on Day 1 of Treatment periods 1 and 2.

Drug: RGB-14-P

Prolia® (Main period)

ACTIVE COMPARATOR

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

Drug: Prolia®

RGB-14-P (Transition period)

EXPERIMENTAL

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

Drug: RGB-14-P

Prolia® (Transition period)

ACTIVE COMPARATOR

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

Drug: Prolia®

RGB-14-P (Continued till transition period)

EXPERIMENTAL

Randomized participants will continue to receive SC injection of RGB-14-P from the main period till Day 1 of Treatment period 3.

Drug: RGB-14-P

Interventions

RGB-14-P DRUG

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

RGB-14-P (Continued till transition period); RGB-14-P (Main period); RGB-14-P (Transition period)

Prolia® DRUG

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

Prolia® (Main period); Prolia® (Transition period)

Eligibility Criteria

• Age: 60 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gedeon Richter Plc.: lead

Study Sites (59)

Miami Clinical Research

Miami, Florida, 33155, United States

Location

Global Health Research Center

Miami Lakes, Florida, 33016, United States

Location

iResearch Atlanta, LLC

Decatur, Georgia, 30030, United States

Location

Excel Clinical Research - Internal Medicine

Las Vegas, Nevada, 89109, United States

Location

Medical Center Hera EOOD - Rheumatology Office

Sofia, Sofia-Grad, 1510, Bulgaria

Location

Medical Center Medconsult Pleven

Pleven, 5803, Bulgaria

Location

UMHAT Kaspela

Plovdiv, 4001, Bulgaria

Location

DKC "Sveti Georgi"

Plovdiv, 4002, Bulgaria

Location

UMHAT Kaspela (Endocrinology/metabolic disease)

Plovdiv, 4002, Bulgaria

Location

UMHAT Pulmed - Reumathology

Plovdiv, 4002, Bulgaria

Location

UMHAT Plovdiv

Plovdiv, Bulgaria

Location

Medical Center - Teodora EOOD

Rousse, Bulgaria

Location

Medical Center Excelsior

Sofia, 1407, Bulgaria

Location

"DCC XVII-Sofia" EOOD

Sofia, 1505, Bulgaria

Location

APAVAR Lekarna

Ostrava, Ostrava-město, 702 00, Czechia

Location

FN Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Klatovska nemocnice, a.s.

Klatovy, 339 01, Czechia

Location

Fakultni nemocnice Plzen

Pilsen, Czechia

Location

Revmatologicky ustav

Prague, 128 50, Czechia

Location

Affidea Praha s.r.o.

Prague, 148 00, Czechia

Location

Fakultni nemocnice v Motole

Prague, 305 99, Czechia

Location

BAZM KKH EOK Szt Ferenc Tagkh

Miskolc, Borsod-Abauj Zemplen county, 3529, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Qualiclinic Kft.

Budapest, 1036, Hungary

Location

Semmelweis Egyetem

Budapest, Hungary

Location

Pest Megyei Flor Ferenc Korhaz

Kistarcsa, 2143, Hungary

Location

Csongrad Megyei Dr Bugyi Istvan Korhaz

Szentes, 6600, Hungary

Location

IRCCS Policlinico San Matteo, Università degli studi di Pavi

Pavia, 27100, Italy

Location

Azienda Ospedaliera di Perugia - Ospedale Santa Maria della

Perugia, 06125, Italy

Location

Azienda Ospedaliero Universitaria Integrata Verona

Veneto, 37126, Italy

Location

Barbara Rewerska Diamond Clin.

Krakow, Lesser Poland Voivodeship, 31-559, Poland

Location

Zespol Poradni Specjalistycznych REUMED, Filia nr 1 Wallenroda

Lublin, Lublin Voivodeship, 20-607, Poland

Location

Lubelskie Centrum Diagnostyczne

Świdnik, Lublin Voivodeship, 21-040, Poland

Location

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Komisja Bioetyczna przy OIL w Bialymstoku

Bialystok, Podlaskie Voivodeship, 15-082, Poland

Location

Nasz Lekarz Osrodek Badan Klinicznych

Bialystok, Podlaskie Voivodeship, 15-082, Poland

Location

ClinicMed Daniluk, Nowak Sp. J

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

Nasz Lekarz Osrodek Badan Klinicznych

Bydgoszcz, 85-065, Poland

Location

Centrum Medyczne Pratia Gdynia

Gdynia, 81-338, Poland

Location

Centrum Medyczne Pratia Katowice

Katowice, 40-081, Poland

Location

Centrum Medyczne Plejady

Krakow, 30-363, Poland

Location

Oswiecimskie Centrum Badan Klinicznych

Oświęcim, 32-600, Poland

Location

RCMed Oddzial Sochaczew

Sochaczew, 96-500, Poland

Location

RCMed

Sochaczew, 96-500, Poland

Location

Medycyna Kliniczna

Warsaw, 00-874, Poland

Location

RCMed Oddział Warszawa

Warsaw, 00-892, Poland

Location

Centrum Medyczne Reuma Park

Warsaw, 02-691, Poland

Location

H. Ntra. Sra. de la Esperanza

Santiago de Compostela, A Coruña, 15705, Spain

Location

Corporacio Sanitaria Parc Tauli de Sabadell - Servicio de reumatologia

Sabadell, Barcelona, 08208, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital de La Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Centro Medico Instituto Palacios

Madrid, 28009, Spain

Location

Clinica Gaias Santiago

Santiago de Compostela, 15703, Spain

Location

Medychnyi tsentr tovarystva z obmezhenoyu vidpovidalnistyu "Medbud-Klinik"

Kyiv, Kyïv, 0 3037, Ukraine

Location

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

Kyiv, Kyïv, 04114, Ukraine

Location

Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova

Vinnytsia, Vinnytsia Oblast, 21018, Ukraine

Location

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

Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

Location

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

Kiyiv, 03049, Ukraine

Location

Med tsentr TOV "Tsentr simeinoi medytsyny plius"

Kiyiv, 04210, Ukraine

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Information Scientific Service
• Organization: Gedeon Richter Plc.

medinfo@richter.hu

+36 1 505 70 32

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: A double-blind design will be used during the main and transition periods.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 21, 2021
• Study Start: September 21, 2021
• Primary Completion: October 2, 2023
• Study Completion: November 15, 2023
• Last Updated: October 24, 2024
• Results First Posted: October 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

UA (6); PL (17); US (4); CZ (7); HU (6); IT (3); ES (6); BU (10)