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Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee

NCT03691974 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-03-01

Study results available
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Summary

The primary objective of the study is to evaluate the effect of fasinumab compared to placebo on peripheral nerves in participants with pain due to Osteoarthritis (OA) of the hip or knee.

The secondary objectives of the study are to:

* Evaluate the efficacy of fasinumab compared to placebo in participants with pain due to OA of the hip or knee
* Evaluate the safety and tolerability of fasinumab compared to placebo in participants with pain due to OA of the hip or knee
* Characterize the concentrations of fasinumab in serum in participants with pain due to OA of the hip or knee
* Evaluate the immunogenicity of fasinumab in participants with pain due to OA of the hip or knee.

Conditions

  • Osteoarthritis, Knee
  • Osteoarthritis, Hip

Interventions

DRUG

Fasinumab

Subcutaneous (SC) every four weeks (Q4W)

OTHER

Placebo

Subcutaneous (SC) every four weeks (Q4W)

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2020-01-30
Completion
2021-01-07
FDA Drug
Yes

Countries

  • United States
  • Poland
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03691974 on ClinicalTrials.gov