A phase 2 clincial study to evaluate safety and efficacy of AMG 785 in Skeletally Mature Adults With a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation With an Intramedullary Nail

A Multi-center, Randomized, Double Blind, Placebo-controlled Study of AMG 785 in Skeletally Mature Adults With a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation With an Intramedullary Nail

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/001044

Enrollment

400

Registered

2009-12-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Fracture Healing Health Condition 2: M844- Pathological fracture, not elsewhere classified

Interventions

Intervention1: AMG 785 dose group 1: Experimental ,Four doses of 70mg AMG 785: AMG 785 70mg , subcutaneous (under the skin) injection Intervention2: AMG 785 dose group 2: Experimental Three doses of 7

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Skeletally mature adults, age 18 to 85 years with radiographically closed growth plates Fresh unilateral closed or Gustilo type I or type II open tibial fracture Definitive fracture fixation with reamed (closed and open fractures) or unreamed (open fractures only) intramedullary nailing

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Major polytrauma or significant axial trauma Associated lower extremity fracture that will delay subjects ability to bear weight beyond the normal time expected for a tibial shaft fracture Use of bone grafts at the time of fracture fixation Pathological fracture or metabolic or bone disease History of symptomatic spinal stenosis or facial nerve paralysis Malignancy within the last 5 years Evidence of the following (currently or within the past 5 years): elevated transaminases, significantly impaired renal function, current hyper- or hypocalcaemia Use of agents affecting bone metabolism Subject refuses to use appropriate methods of contraception

Design outcomes

Primary

Measure	Time frame
Time to radiographic healing for the AMG 785 and placebo groupsTimepoint: [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]	—

Secondary

Measure	Time frame
- Physical functioning as measured by change from baseline in the SF-36 PFTimepoint: [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] ;-Adverse events, vital signs, laboratory data, ECG parameters, formation of anti-AMG 785 antibodies, change in lumbar spine bone mineral density, long-term effect on radiographic healing and callus size and qualityTimepoint: [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ] ;-Subject incidence of revision surgeryTimepoint: [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] ;-Time to clinical healing as determined by the ability to bear weight on the fractured limb and the absence of pain at the fracture siteTimepoint: [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]	—

Measure

Time frame

- Physical functioning as measured by change from baseline in the SF-36 PFTimepoint: [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] ;-Adverse events, vital signs, laboratory data, ECG parameters, formation of anti-AMG 785 antibodies, change in lumbar spine bone mineral density, long-term effect on radiographic healing and callus size and qualityTimepoint: [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ] ;-Subject incidence of revision surgeryTimepoint: [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] ;-Time to clinical healing as determined by the ability to bear weight on the fractured limb and the absence of pain at the fracture siteTimepoint: [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

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Countries

Australia, Bulgaria, Canada, Denmark, France, Germany, Greece, India, Italy, Latvia, Poland, Romania, Russian Federation, Slovakia, United Kingdom, United States of America

Contacts

Public ContactDr Veena Jaguste

Amgen Technology Pvt Ltd

tsawant@amgen.com91-22-67869301

Outcome results

None listed

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