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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05405725
Other study ID # ALK22/ENZ215-DEN2
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 4, 2022
Est. completion date August 2024

Study information

Verified date July 2022
Source Enzene Biosciences Ltd.
Contact Dr. Harish Shandilya
Phone +9102067184202
Email harish.shandilya@enzene.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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) and Prolia® in Postmenopausal Women with Osteoporosis


Recruitment information / eligibility

Status Recruiting
Enrollment 504
Est. completion date August 2024
Est. primary completion date February 2024
Accepts healthy volunteers No
Gender Female
Age group 55 Years to 85 Years
Eligibility Inclusion Criteria: 1. Willing to provide voluntary written informed consent and able to comply with the protocol requirements 2. Postmenopausal women aged = 55 and = 85 years 3. Body weight = 50 kg and = 90 kg 4. Diagnosed with osteoporosis, with absolute BMD at the lumbar spine (L1-L4 region) as measured by dual-energy X ray absorptiometry (DXA) at screening 5. At least 5 years of postmenopausal status confirmed by follicle-stimulating hormone (FSH) levels at screening 6. At least one hip joint and two vertebrae in L1-L4 region evaluable by DXA 7. No other clinically significant medical history, vital signs, physical examination, laboratory profiles as deemed by the Investigator or designee Exclusion Criteria: 1. Known hypersensitivity to denosumab or any of the excipients of the study drug 2. Known intolerance to, or malabsorption of calcium or vitamin D supplements 3. Previous exposure to Prolia® or any other denosumab biosimilar 4. Previous use of oral bisphosphonates 5. Use of intravenous bisphosphonates within the past 5 years prior to screening 6. 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 7. Any prior use of fluoride or strontium 8. 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) 9. 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 10. Known sensitivity to drug products derived from mammalian cell lines 11. History of one severe or more than two moderate vertebral fractures per Genant classification as determined by the central reading center 12. History of hip fracture or bilateral hip replacement 13. Total hip or femoral neck T-score <-4.0 14. History and/or presence of atypical femoral fracture 15. Presence of any active healing fracture according to the Investigator's assessment 16. History of any transplant or chronic immunosuppression (including patients on immunosuppressive therapy) 17. Severe liver dysfunction 18. Positive testing for hepatitis B (hepatitis B virus surface antigen [HbsAg]) or hepatitis C (hepatitis C virus antibody [HCV Ab]) virology 19. Known history of human immunodeficiency virus (HIV) infection or positive serology for HIV at screening 20. Significantly impaired renal function or receiving dialysis 21. Oral or dental conditions 22. Major surgery within 8 weeks prior to screening or anticipated major surgery during the study 23. 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 24. Patient with an active infection or history of infection 25. 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

Study Design


Intervention

Biological:
ENZ215
Enrolled women with postmenopausal osteoporosis will receive ENZ215 (60mg)
Prolia
Enrolled women with postmenopausal osteoporosis will receive Prolia

Locations

Country Name City State
Czechia MEDICAL PLUS s.r.o. Uherské Hradište

Sponsors (2)

Lead Sponsor Collaborator
Enzene Biosciences Ltd. Alkem Laboratories Ltd

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the efficacy of ENZ215 when compared to Prolia in patients with postmenopausal osteoporosis, in terms of change in bone mineral density (BMD) at lumbar spine Percentage change in BMD at lumbar spine (L1-L4 region) measured by dual-energy X-ray absorptiometry (DXA) 360 days
Primary To compare the area under the effect curve (AUEC) of serum C-telopeptide of Type-1 collagen (sCTX) levels AUEC of sCTX over the initial 6 months (from Day 1 pre-dose to Month 6 pre-dose) will be assessed. 180 days
Secondary To compare the immunogenicity potential of ENZ215 and Prolia ADAs incidence at baseline and different timepoints from 1 month to 12 months and during open-label switch over period will be assessed. 540 days
Secondary To compare the safety and tolerability of ENZ215 and Prolia Treatment-emergent serious and non-serious adverse events (TEAEs) during main treatment period and open-label switch-over period will be assessed 540 days
Secondary To compare the pharmacokinetics of ENZ215 and Prolia Cmax of denosumab measured at predefined timepoints. 360 days
Secondary To compare the pharmacokinetics of ENZ215 and Prolia Tmax of denosumab measured at predefined timepoints. 360 days
Secondary To compare the pharmacokinetics of ENZ215 and Prolia partial AUC of denosumab measured at predefined timepoints. 360 days
Secondary To compare the change in serum procollagen type 1 N-terminal propeptide (sP1NP) levels 180 days
Secondary To compare the change in BMD at the lumbar spine Percentage change in BMD at lumbar spine measured by DXA from baseline to predefined timepoint 180 days
Secondary To compare the change in BMD at total hip and femoral neck Percentage change in BMD at total hip and femoral neck measured by DXA from baseline to Month to predefined timepoint 360 days
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