Comparative Efficacy, Safety, PK, and Immunogenicity Study

Status unconfirmed · Phase 3

Conditions studied: Osteoporosis, Postmenopausal

In brief

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.

Key facts

Study ID

NCT05853354

Run by

Luye Pharma Group Ltd.

People needed

392

Starts

2023-04-05

Expected to finish

2025-12-30

Last updated by the study team

2024-04-26

Who can join

Age: 60 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

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.
• Participant has other disease conditions where there is bone/joint involvement (e.g., rheumatoid arthritis, ankylosing spondylitis, gout, multiple myeloma, achondroplasia, bone metastases, renal osteodystrophy, osteomyelitis).
• Participant has hypocalcemia (defined as albumin adjusted serum calcium level < 2.0 mmol/L [8.0 mg/dL] Grade 2 per Common Terminology Criteria for Adverse Events version 5.0) or hypercalcemia (defined as albumin adjusted serum calcium levels > 2.62 mmol/L [10.50 mg/dL]).
• Participant has vitamin D deficiency (defined as 25-hydroxy vitamin D level < 20 ng/mL [< 50 nmol/L]).
• Note: Oral replenishment of vitamin D is permitted at the discretion of the Investigator and in accordance with local standard of care during the Screening Period. Participants can be enrolled if a repeat test (post supplementation) prior to enrollment shows corrected 25-hydroxy vitamin D level ≥ 20 ng/mL (≥ 50 nmol/L).
• Participant has any malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years.
• Participant has known history of liver cirrhosis.
• Participant has known history of hepatitis B, hepatitis C, or HIV infection, or an active infection including, but not limited to SARS-CoV-2, tests positive for hepatitis B (positive HBsAg, positive anti-HBc with negative anti-HBs), hepatitis C (hepatitis C antibody), or HIV antibody during the Screening Period.
• Participant has oral or dental conditions:
• Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw.
• Active dental or jaw condition which requires oral surgery.

Where it is running

• Clinical Trials Management Services, LLC — Thousand Oaks, California, United States
• Indago Research and Health Center, Inc. — Hialeah, Florida, United States
• Valley Institute of Research — Fort Worth, Texas, United States
• MHAT Dr. Atanas Dafovski AD — Kardzhali, Bulgaria
• Medical Centre Leo Clinic EOOD — Plovdiv, Bulgaria
• Diagnostic-consultative center Ascendent EOOD — Sofia, Bulgaria
• Medical Center Leo Clinic EOOD — Varna, Bulgaria
• CCR Brno s.r.o. — Brno, Czechia
• Synexus Prague — Prague, Czechia
• Gifu Prefectural General Med C. — Gifu, Gihu, Japan
• Asakawa Orthopedic Clinic — Chikugo, Hukuoka, Japan
• Obase Hospital - Orthopedics — Miyako-gun, Hukuoka, Japan
• Himeno Hospital — Yame-gun, Hukuoka, Japan
• Marunouchi Hospital — Matsumoto-shi, Nagano, Japan
• Nemoto Geka SeikeiGeka — Fujimi, Saitama, Japan
• Kobayakawa Orthopedic Rheumatologic — Fukuroi, Shizuoka, Japan
• Med Teda Ooimachi Orthopaedic — Shinagawa-ku, Tôkyô, Japan
• Koenji Orthopedic Surgery — Shinagawa-ku, Tôkyô, Japan
• Shimonoseki City Hospital — Shimonoseki, Yamaguchi, Japan
• Nakamura Hospital — Beppu, Ôita, Japan
• Centrum Medyczne Pratia Poznan — Skórzewo, Greater Poland Voivodeship, Poland
• Centrum Medyczne Pratia Poznan — Skórzewo, Greater Poland Voivodeship, Poland
• Synexus Polska Sp. z o.o. — Katowice, Silesian Voivodeship, Poland
• Centrum Medyczne Pratia Czestochowa — Częstochowa, Poland
• Synexus Polska Sp. z o.o. — Częstochowa, Poland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.