Comparative Efficacy, Safety, PK, and Immunogenicity Study

NCT05853354 | Active Not Recruiting Phase 3 FDA Drug

• 3 other identifiers: LY06006/MRCT-301IND 1385912022-002312-23
• Study Type: interventional
• Target: 392
• Locations: 5 countries
• Sites: 39

Brief Summary

this comparative clinical study is designed to demonstrate that LY06006 and EU-Prolia have no clinically meaningful differences in clinical efficacy, pharmacodynamic (PD), safety, PK, and immunogenicity in postmenopausal women with osteoporosis.

Conditions

Osteoporosis, Postmenopausal

Keywords

Comparative efficacy;safety;PK; immunogenicity; biosimilar

Outcome Measures

Primary Outcomes (2)

• To demonstrate equivalent efficacy between LY06006 and EU-Prolia, in terms of BMD in female participants with postmenopausal osteoporosis;

  %CfB in lumbar spine BMD at Month 12

  12 months

• EU Marketing Authorization only: To demonstrate similar PD between LY06006 and EU-Prolia, in terms of the bone resorption marker sCTX in female participants with postmenopausal osteoporosis

  EU Marketing Authorization only: standardized AUEC0-6m (post first dose) of -%CfB in bone resorption marker sCTX over 6 months

  6 months

Secondary Outcomes (1)

• To provide additional comparative efficacy data of LY06006 with EU-Prolia in female participants with postmenopausal osteoporosis

  6-12 months

Study Arms (2)

LY06006

EXPERIMENTAL

to be administered 2 doses to the patients at the main treatment period and 1 dose at the transition period.

Biological: Denosumab

EU Prolia

ACTIVE COMPARATOR

to be administered 2 doses to the patients at the main treatment period and 1 dose at the transition period.

Biological: Denosumab

Interventions

Denosumab BIOLOGICAL

Sterile, preservative-free, solution of denosumab packed in 1-mL pre-filled glass syringes for subcutaneous administration.Each syringe contains 60 mg denosumab (60 mg/mL solution) and is intended for single administration once every 6 months.

EU Prolia; LY06006

Eligibility Criteria

• Age: 60 Years - 90 Years
• Gender Eligibility Details: lack of menstrual period for at least 12 months prior to Screening Visit, for which there is no other obvious pathological or physiological cause
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age
• Participant is ≥ 60 to ≤ 90 years of age inclusive, at the time of signing the informed consent.
• Type of Participant and Disease Characteristics
• Participant is an ambulatory postmenopausal woman (defined as lack of menstrual period for at least 12 months prior to Screening Visit, for which there is no other obvious pathological or physiological cause).
• Serum FSH test can be done at the Screening Visit in case of uncertainty.
• Female participants who underwent bilateral oophorectomy (with or without hysterectomy) at least 6 weeks prior to the Screening Period are eligible to participate.
• Participant is diagnosed with osteoporosis, with absolute BMD consistent with a T-score of ≤ -2.5 and ≥ -4.0 at the lumbar spine (L1-L4 region) as measured by DXA at the Screening Visit.
• Participant has at least two lumbar vertebrae in L1-L4 region and one hip evaluable by DXA for BMD measurement at the Screening Visit.
• Weight 5. Participant has body weight ≥ 50 kg and ≤ 90 kg at Screening. Informed Consent 6. Participant is able to read and understand, and willing to provide signed informed consent as described in Appendix 1, Section 10.1.3 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

You may not qualify if:

• Medical Conditions
• Participant has a history and/or presence of any severe or more than two moderate vertebral fractures as determined by central reading of lateral spine X-ray at Screening Visit.
• Participant has a history and/or presence of hip fracture.
• Participant has a history and/or presence of atypical femur fracture.
• Participant presents with any active healing fracture, per assessment of the Investigator.
• Participant has a history of bilateral hip replacement (unilateral is allowed if the other hip is evaluable by DXA).
• Participant has history and/or presence of osteonecrosis of the external auditory canal.
• Evidence of any of the following conditions which may affect BMD or interfere with the interpretation of the findings:
• Participant has a history of bone disease e.g., osteomalacia, osteopetrosis, Paget's disease, or osteogenesis imperfecta.
• Participant has a history of metabolic or other endocrinologic diseases such as Cushing's disease, hyperprolactinemia, hypopituitarism, acromegaly, malabsorption syndrome (or any gastrointestinal disorders associated with malabsorption, e.g., Crohn's disease and chronic pancreatitis).
• Participant has a history of chronic inflammatory diseases, obvious sclerosis, osteophytosis, severe scoliosis, or other degenerative changes due to other co-morbidities.
• Participant has a history or current hyperparathyroidism or hypoparathyroidism. Note: Mild non-clinically significant secondary hyperparathyroidism may be acceptable upon discussion with the Medical Monitor.
• Participant has current uncontrolled hyperthyroidism or hypothyroidism. Note: Participants with hypothyroidism who are on stable thyroid hormone replacement therapy may be allowed per the following criteria:
• If TSH level is within normal range, the participant is eligible.
• If TSH level is elevated (\> 5.5 μIU/mL and ≤ 10.0 μIU/mL) and serum free T4 is within normal range, the participant is eligible. If TSH is below the lower level of normal, the participant should be excluded.

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (39)

Clinical Trials Management Services, LLC

Thousand Oaks, California, 91360, United States

Location

Indago Research and Health Center, Inc.

Hialeah, Florida, 33012, United States

Location

Valley Institute of Research

Fort Worth, Texas, 76164, United States

Location

MHAT Dr. Atanas Dafovski AD

Kardzhali, 6600, Bulgaria

Location

Medical Centre Leo Clinic EOOD

Plovdiv, 4003, Bulgaria

Location

Diagnostic-consultative center Ascendent EOOD

Sofia, 1202, Bulgaria

Location

Medical Center Leo Clinic EOOD

Varna, 9000, Bulgaria

Location

CCR Brno s.r.o.

Brno, 60200, Czechia

Location

Synexus Prague

Prague, 12000, Czechia

Location

Gifu Prefectural General Med C.

Gifu, Gihu, 500-8717, Japan

Location

Asakawa Orthopedic Clinic

Chikugo, Hukuoka, 833-0031, Japan

Location

Obase Hospital - Orthopedics

Miyako-gun, Hukuoka, 800-0344, Japan

Location

Himeno Hospital

Yame-gun, Hukuoka, 834-0115, Japan

Location

Marunouchi Hospital

Matsumoto-shi, Nagano, 390-8601, Japan

Location

Nemoto Geka SeikeiGeka

Fujimi, Saitama, 354-0021, Japan

Location

Kobayakawa Orthopedic Rheumatologic

Fukuroi, Shizuoka, 437-0061, Japan

Location

Med Teda Ooimachi Orthopaedic

Shinagawa-ku, Tôkyô, 140-0014, Japan

Location

Koenji Orthopedic Surgery

Shinagawa-ku, Tôkyô, 166-0003, Japan

Location

Shimonoseki City Hospital

Shimonoseki, Yamaguchi, 750-8520, Japan

Location

Nakamura Hospital

Beppu, Ôita, 874-0937, Japan

Location

Centrum Medyczne Pratia Poznan

Skórzewo, Greater Poland Voivodeship, 60-185, Poland

Location

Centrum Medyczne Pratia Poznan

Skórzewo, Greater Poland Voivodeship, 60-535, Poland

Location

Synexus Polska Sp. z o.o.

Katowice, Silesian Voivodeship, 40-040, Poland

Location

Centrum Medyczne Pratia Czestochowa

Częstochowa, 42-200, Poland

Location

Synexus Polska Sp. z o.o.

Częstochowa, 42-202, Poland

Location

Synexus Polska Sp. z o.o.

Gdansk, 80-382, Poland

Location

Centrum Medyczne Pratia Gdynia

Gdynia, 81-338, Poland

Location

Pratia Jelenia Gora

Jelenia Góra, 58-506, Poland

Location

Centrum Medyczne Pratia Katowice

Katowice, 40-081, Poland

Location

Pratia MCM Krakow

Krakow, 30-727, Poland

Location

Krakowskie Centrum Medyczne Sp.z o.o.

Krakow, 31-501, Poland

Location

Synexus Polska Sp. z. o.o.

Lodz, 90-127, Poland

Location

Centrum Medyczne AMED Oddzial w Lodzi

Lodz, 91-363, Poland

Location

Synexus Polska Sp. z o.o.

Poznan, 60-702, Poland

Location

FutureMeds Warszawa Centrum

Warsaw, 00-215, Poland

Location

Synexus Polska Sp. z o.o.

Warsaw, 02-672, Poland

Location

Centrum Medyczne AMED

Warsaw, 7 03-291, Poland

Location

Synexus Polska Sp. z o.o.

Wroclaw, 50-381, Poland

Location

FutureMeds Sp. z o.o.

Wroclaw, 53-673, Poland

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

Study Officials

• Joe Tai

  Luye Pharma Group Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Upon enrollment, each participant will receive a unique participant identification number.Participant numbers must not be re-used for any other participants. Prior to dosing in the Transition Period and to maintain the blind throughout the study, participants will be re-randomized and receive a second randomization number. Participants randomized to receive EU-Prolia in the Main Period will be re-randomized to receive either LY06006 or continue to receive EU-Prolia. Participants who received LY06006 in the Main Period will be re-randomized to continue to receive LY06006 in the Transition Period. All participant assignment during the Transition Period will be performed via the IRT system to maintain the blind of treatment assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, parallel-group, active-controlled, comparative study (Main Period) with a Transition Period to compare the efficacy, PD, safety, PK and immunogenicity of LY06006 and EU-Prolia among female participants with postmenopausal osteoporosis.

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: April 5, 2023
• Primary Completion: July 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

JP (11); US (3); BU (4); PL (19); CZ (2)