Status:
UNKNOWN
A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®
Lead Sponsor:
Enzene Biosciences Ltd.
Collaborating Sponsors:
Alkem Laboratories Ltd
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
55-85 years
Phase:
PHASE3
Brief Summary
This is a phase 3 Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Enzene Denosumab (ENZ215)...
Eligibility Criteria
Inclusion
- Willing to provide voluntary written informed consent and able to comply with the protocol requirements
- Postmenopausal women aged ≥ 55 and ≤ 85 years
- Body weight ≥ 50 kg and ≤ 90 kg
- Diagnosed with osteoporosis, with absolute BMD at the lumbar spine (L1-L4 region) as measured by dual-energy X ray absorptiometry (DXA) at screening
- At least 5 years of postmenopausal status confirmed by follicle-stimulating hormone (FSH) levels at screening
- At least one hip joint and two vertebrae in L1-L4 region evaluable by DXA
- No other clinically significant medical history, vital signs, physical examination, laboratory profiles as deemed by the Investigator or designee
Exclusion
- Known hypersensitivity to denosumab or any of the excipients of the study drug
- Known intolerance to, or malabsorption of calcium or vitamin D supplements
- Previous exposure to Prolia® or any other denosumab biosimilar
- Previous use of oral bisphosphonates
- Use of intravenous bisphosphonates within the past 5 years prior to screening
- Use of parathyroid hormone or its derivatives, systemic hormone replacement therapy, selective estrogen-receptor modulators, or tibolone or calcitonin within 12 months prior to enrollment
- Any prior use of fluoride or strontium
- Systemic glucocorticoids (≥ 5 mg prednisone equivalent per day or cumulative dose ≥ 50 mg) for more than 10 days within 3 months prior to enrollment (topical and inhaled corticosteroids are allowed)
- Other bone active drugs (i.e. drugs affecting bone metabolism) including heparin, anti-epileptics (except for benzodiazepines and pregabalin), systemic ketoconazole, adrenocorticotrophic hormone (ACTH), lithium, protease inhibitors, gonadotropin-releasing hormone (GnRH) agonists, or anabolic steroids within the past 3 months prior to screening
- Known sensitivity to drug products derived from mammalian cell lines
- History of one severe or more than two moderate vertebral fractures per Genant classification as determined by the central reading center
- History of hip fracture or bilateral hip replacement
- Total hip or femoral neck T-score \<-4.0
- History and/or presence of atypical femoral fracture
- Presence of any active healing fracture according to the Investigator's assessment
- History of any transplant or chronic immunosuppression (including patients on immunosuppressive therapy)
- Severe liver dysfunction
- Positive testing for hepatitis B (hepatitis B virus surface antigen \[HbsAg\]) or hepatitis C (hepatitis C virus antibody \[HCV Ab\]) virology
- Known history of human immunodeficiency virus (HIV) infection or positive serology for HIV at screening
- Significantly impaired renal function or receiving dialysis
- Oral or dental conditions
- Major surgery within 8 weeks prior to screening or anticipated major surgery during the study
- Clinically significant leukopenia, neutropenia, or anemia as determined by the Investigator or any other clinically significant medical condition or laboratory abnormality that, in the opinion of the Investigator, would pose a risk to patient safety or interfere with adherence to study procedures, study completion, or the interpretation of study results
- Patient with an active infection or history of infection
- Suspected signs and symptoms of COVID-19/confirmed COVID-19 or with recent history of travel/contact (less than 2 weeks from screening) with any COVID-19 positive patient/isolation/quarantine
Key Trial Info
Start Date :
July 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT05405725
Start Date
July 4 2022
End Date
August 1 2024
Last Update
August 2 2022
Active Locations (1)
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1
MEDICAL PLUS s.r.o.
Uherské Hradiště, Czechia