A study of FKS518 compared to Prolia in Postmenopausal Women with Osteoporosis (LUMIADE-3 Study)

A Double-blind, Randomized, Multicenter, Multiple-dose, 2-arm, Parallel-group Study to Evaluate Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 - Proposed Biosimilar to Denosumab with Prolia® in Postmenopausal Women with Osteoporosis (LUMIADE-3 Study) - LUMIADE-3 Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004422-31-BG

Enrollment

556

Registered

2020-12-30

Start date

2021-03-17

Completion date

Unknown

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis in Postmenopausal Women MedDRA version: 20.0 Level: HLT Classification code 10005992 Term: Bone metabolism disorders System Organ Class: 100000004861

Interventions

Product Code: FKS518 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: DENOSUMAB CAS Number: 615258-40-7 Current Sponsor code: FKS518 Other descriptive name: DENOS

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Female =55 to =85 years of age, inclusive, at screening. 2. Subject should have confirmed postmenopausal status, defined as age-related or early/premature amenorrhea =12 consecutive months and increased follicle-stimulating hormone (FSH) >40 mIU/mL at screening; or surgical menopause (bilateral oophorectomy with or without hysterectomy) =12 months prior to screening. 3. Absolute BMD consistent with T-score =-2.5 and =-4.0 at the lumbar spine as measured by DXA as per central assessment. 4. At least 2 vertebrae in the L1-L4 region and at least 1 hip joint are 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 370 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 186

Exclusion criteria

Exclusion criteria: 1. History and/or presence of 1 severe or >2 moderate vertebral fractures or hip fracture confirmed by x-ray. 2. Presence of active healing fracture at screening. 3. History and/or presence of bone-related disorders, such as but not limited to Paget’s disease, osteomalacia, hyperparathyroidism (or parathyroid disorders), or renal osteodystrophy. 4. Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures, poor oral hygiene, periodontal, and/or pre-existing dental disease as assessed by the Investigator. 5. Prior denosumab (Prolia, Xgeva, or proposed denosumab biosimilar) exposure. 6. Prior use of fluoride within the 5 years before inclusion in the study. 7. Any current or prior use of strontium ranelate.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate equivalent efficacy of the proposed biosimilar denosumab FKS518 to US-licensed Prolia (US-Prolia) in women with postmenopausal osteoporosis (PMO). For Marketing Authorization Application (MAA) in the European Union (EU) and European Economic Area (EEA) only: to demonstrate equivalent efficacy and pharmacodynamics (PD) of the proposed biosimilar denosumab FKS518 to US- licensed Prolia (US-Prolia) in women with PMO.;Secondary Objective: To compare the safety, tolerability, PD and immunogenicity of FKS518 to US-Prolia in women with PMO.;Primary end point(s): Primary endpoint: • Percent change from baseline in LS-BMD by DXA at Week 52. • Area under the effect curve (AUEC) of serum CTX up to Week 26 (for MAA in the EU and EEA only).;Timepoint(s) of evaluation of this end point: From baseline up to Week 26 and to Week 52	—

Measure

Time frame

Main Objective: To demonstrate equivalent efficacy of the proposed biosimilar denosumab FKS518 to US-licensed Prolia (US-Prolia) in women with postmenopausal osteoporosis (PMO). For Marketing Authorization Application (MAA) in the European Union (EU) and European Economic Area (EEA) only: to demonstrate equivalent efficacy and pharmacodynamics (PD) of the proposed biosimilar denosumab FKS518 to US- licensed Prolia (US-Prolia) in women with PMO.;Secondary Objective: To compare the safety, tolerability, PD and immunogenicity of FKS518 to US-Prolia in women with PMO.;Primary end point(s): Primary endpoint: • Percent change from baseline in LS-BMD by DXA at Week 52. • Area under the effect curve (AUEC) of serum CTX up to Week 26 (for MAA in the EU and EEA only).;Timepoint(s) of evaluation of this end point: From baseline up to Week 26 and to Week 52

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Secondary

Measure	Time frame
Secondary end point(s): Efficacy: • Percent change from baseline in BMD at femoral neck and total hip by DXA at Week 52. Pharmacodynamic: • Percent change from baseline in serum P1NP at Week 52. • Percent change from baseline in serum CTX at Week 52. Safety and tolerability: • Occurrence of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) during Core Treatment Period, Transition Period, and overall. • Occurrence of treatment-emergent adverse events of special interest (AESIs): drug-related hypersensitivity/allergic reactions (Common Terminology criteria for Adverse Events [CTCAE] Grade =3 or reported as SAEs), and adverse events leading to IP discontinuation or study withdrawal during Core Treatment Period, Transition Period, and overall. • Occurrence of injection site reactions (local tolerability) during Core Treatment Period, Transition Period, and overall. Immunogenicity: • Antidrug antibody (ADA) incidence during Core Treatment Period, Transition Period, and overall. • ADA titer during the Core Treatment Period, Transition Period. • Neutralizing antibody (NAb) incidence during the Core Treatment Period, Transition Period, and overall.;Timepoint(s) of evaluation of this end point: Week 52, Week 72 and overall	—

Measure

Time frame

Secondary end point(s): Efficacy: • Percent change from baseline in BMD at femoral neck and total hip by DXA at Week 52. Pharmacodynamic: • Percent change from baseline in serum P1NP at Week 52. • Percent change from baseline in serum CTX at Week 52. Safety and tolerability: • Occurrence of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) during Core Treatment Period, Transition Period, and overall. • Occurrence of treatment-emergent adverse events of special interest (AESIs): drug-related hypersensitivity/allergic reactions (Common Terminology criteria for Adverse Events [CTCAE] Grade =3 or reported as SAEs), and adverse events leading to IP discontinuation or study withdrawal during Core Treatment Period, Transition Period, and overall. • Occurrence of injection site reactions (local tolerability) during Core Treatment Period, Transition Period, and overall. Immunogenicity: • Antidrug antibody (ADA) incidence during Core Treatment Period, Transition Period, and overall. • ADA titer during the Core Treatment Period, Transition Period. • Neutralizing antibody (NAb) incidence during the Core Treatment Period, Transition Period, and overall.;Timepoint(s) of evaluation of this end point: Week 52, Week 72 and overall

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Countries

Bulgaria, Czechia, Czech Republic, Estonia, Georgia, Hungary, Poland

Contacts

Public ContactClinical Development

Fresenius Kabi SwissBioSim GmbH

clinical.development@fresenius-kabi.com+41793075735

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026