Safety and pharmacokinetics clinical of BPS804 in adult patients with osteogenesis imperfecta

A randomized, open label intra-patient dose escalation study with an untreated reference group to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of multiple infusions of BPS804 in adults with moderate osteogenesis imperfecta - NA

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001465-41-BE

Enrollment

Registered

2011-05-23

Start date

2011-07-20

Completion date

Unknown

Last updated

2017-08-21

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

Conditions

Patients with previously established diagnosis of osteogenesis imperfecta (OI). OI is a rare genetic disorder of the connective tissue characterized by bone fragility and reduced bone mass. OI comprises a group of inherited disorders which primarily, but not always, arise from mutations in the genes encoding type I collagen. MedDRA version: 14.1 Level: PT Classification code 10031243 Term: Osteogenesis imperfecta System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Product Name: NA Product Code: BPS804 Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: NA CAS Number: NA Current Sponsor code: BPS804 Other descriptive name: Anti-scler

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Osteogenesis imperfecta Two or more previous fractures Bone mineral density Z-score of = -1.0 and > -4.0 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 11 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: Open epiphyses Fracture within last 2 weeks Treatment with bisphosphonates/teriparatide (last 6 months) Surgery within last year

Design outcomes

Primary

Measure	Time frame
Main Objective: Assessment of safety, tolerability, pharmacodynamics, and bone mass density.;Secondary Objective: Assessment of pharmacokinetic profile, total/free sclerostin in serum, and immunogenicity.;Primary end point(s): Safety, tolerability, biomarkers and bone mineral density;Timepoint(s) of evaluation of this end point: Over 21 weeks	—

Secondary

Measure	Time frame
Secondary end point(s): Multiple endpoints will be assessed in this trial, related to efficacy, pharmacodynamics, safety, health related quality of life, pharmacokinetics, pharmacogenetics.;Timepoint(s) of evaluation of this end point: Over 21 weeks	—

Countries

Belgium, Canada, Germany

Contacts

Public ContactClinical Trial Information Desk

Novartis Pharma Services AG

clinicaltrial.enquiries@novartis.com+41613241111

Outcome results

None listed

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