Postmenopausal osteoporosis MedDRA version: 20.0 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Enzene Denosumab (ENZ215)
Product Code: ENZ215
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Denosumab
CAS Number: 615258-40-7
Current Sponsor co
Sponsors
Alkem Laboratories Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women aged = 55 and = 85 years 2. Body weight = 50 kg and = 90 kg 3. Diagnosed with osteoporosis, with absolute BMD consistent with T-scores of = -2.5 and = - 4.0 at the lumbar spine (L1-L4 region) as measured by dual-energy X ray absorptiometry (DXA) at screening 4. At least 5 years of postmenopausal status confirmed by follicle-stimulating hormone (FSH) levels at screening 5. At least one hip joint and two vertebrae in L1-L4 region evaluable by DXA Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 126 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 378
Exclusion criteria
Exclusion criteria: 1.Previous exposure to Prolia® or any other denosumab biosimilar 2.Previous use of oral bisphosphonates: a.Used for 3 or more years cumulatively b.If used for 3 times upper limit of normal) 15.Positive testing for hepatitis B ([HbsAg]) or hepatitis C ([HCV Ab]) virology 16.Known history of human immunodeficiency virus (HIV) infection or positive serology for HIV at screening 17.Significantly impaired renal function (determined by glomerular filtration rate of < 45 mL/min/1.73 m2 by the Modification of Diet in Renal Disease (MDRD) formula, as calculated by the central laboratory) or receiving dialysis 18.Oral or dental conditions: a.Osteomyelitis or history and/or presence of osteonecrosis of the jaw (ONJ) b.Presence of risk factors for ONJ c.Active dental or jaw condition which requires oral surgery d.Planned invasive dental procedure 19.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 20.Patient with an active infection or history of infection as follows: a.Any active infection for which systemic anti-infectives were used within 4 weeks prior to randomization b.A serious infection defined as requiring hospitalization or intravenous anti infectives within 8 weeks prior to ranomization c.Recurrent or chronic infections or other active infection that, in the opinion of the Investigator, might compromise the safety of the patient 21.Evidence of any of the following conditions per laboratory test results, medical history, electrocardiogram (ECG), DXA, or X-ray review: a.Uncontrolled hyperthyroidism or hypothyroidism b.History or current hyperparathyroidism or hypoparathyroidism (intact parathyroid hormone levels not within normal range) c.Vitamin D deficiency defined as 25 (OH) vitamin D level < 20 ng/mL (< 50 nmol/L) d.Current hypocalcemia (albumin-adjusted s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the efficacy of ENZ215 when compared to Prolia® in patients with postmenopausal osteoporosis, in terms of change in BMD at the lumbar spine from baseline to Month 12 •To compare the AUEC of sCTX levels from baseline to Month 6 ;Secondary Objective: •To compare the change in sP1NP levels from baseline to Month 6 •To compare the change in BMD at lumbar spine from baseline to Month 6 •To compare the change in BMD at total hip and femoral neck from baseline to Month 6 and Month 12 •To compare the immunogenicity potential of ENZ215 and Prolia® •To compare the safety and tolerability of ENZ215 and Prolia® •To compare the pharmacokinetics of ENZ215 and Prolia®;Primary end point(s): •Percentage change in BMD at lumbar spine (L1-L4 region) measured by DXA from baseline to Month 12 •AUEC of sCTX over the initial 6 months (from Day 1 pre-dose to Month 6 pre dose) ;Timepoint(s) of evaluation of this end point: Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percentage change in sP1NP concentrations from baseline to Month 1, Month 3, and Month 6 • Percentage change in BMD at lumbar spine measured by DXA from baseline to Month 6 • Percentage change in BMD at total hip and femoral neck measured by DXA from baseline to Month 6 and Month 12 • ADAs incidence at baseline (Day 1) and Months 1, 3, 6, 9, and 12 and during open label switch over period, i.e. Months 15 and 18 • Treatment emergent serious and non serious adverse events (TEAEs) during main treatment period and open label switch over period • Alteration in clinical laboratory parameters during main treatment period and open-label switch over period • PK Parameters (Cmax, Tmax, partial AUC(0-1 month), AUC(0-6month)) of denosumab measured at baseline (Day 1), Day 8, Day 15, Month 1, Month 3, Month 6 (prior to second dose), and Month 12;Timepoint(s) of evaluation of this end point: • Percentage change in sP1NP concentrations from baseline to Month 1, Month 3, and Month 6 • Percentage change in BMD at lumbar spine measured by DXA from baseline to Month 6 • Percentage change in BMD at total hip and femoral neck measured by DXA from baseline to Month 6 and Month 12 • ADAs incidence at baseline (Day 1) and Months 1, 3, 6, 9, and 12 and during open label switch over period, i.e. Months 15 and 18 • PK Parameters (Cmax, Tmax, partial AUC(0-1 month), AUC(0-6month)) of denosumab measured at baseline (Day 1), Day 8, Day 15, Month 1, Month 3, Month 6 (prior to second dose), and Month 12 | — |
Countries
Bulgaria, Czechia, Denmark, Lithuania, Poland, Serbia, Spain
Contacts
Public ContactClinical Trial Information Desk
Alkem Laboratories Limited
Outcome results
None listed