NCT02205814

Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee

A Double-blind, Randomised, Placebo-controlled, Four Parallel Arm, Dose-finding Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Single Intra-articular Injections of Fasitibant in Patients With Symptomatic Osteoarthritis of the Knee.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 436 (actual)
• Sponsor: Menarini Group · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is designed as a double-blind, randomised, placebo-controlled, four parallel arm, dose-finding study, to be conducted in approximately 26 sites, to evaluate the efficacy, safety, tolerability, and pharmacokinetics of single intra-articular (IA) injections of fasitibant in patients with symptomatic osteoarthritis (OA) of the knee. Approximately 400 male and female patients 40-80 years old, with BMI \< 30 kg/m² and with a clinical diagnosis of symptomatic primary osteoarthritis of the knee will be randomised to a total of 4 treatment arms. Each arm includes a single intra-articular injection of one of three dosages of fasitibant (low, intermediate and high dose) OR placebo. The randomisation ratio will be 1:1:1:1. The primary efficacy variable will be the change of the Western Ontario and McMaster Universities Visual Analogue Scale 3.1 A (WOMAC VA 3.1 A) (total pain) subscore from baseline up to 2 weeks after randomisation. Safety will be assessed by monitoring adverse events and clinical laboratory tests; local tolerability at the injection site will also be assessed. In addition, the population pharmacokinetics and the exposure-response relationship will be evaluated. The individual experimental clinical phase will last up to maximal 15 weeks encompassing 7 planned visits at site, including screening, randomisation, 4 follow-up visits and the End of study visit.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	Fasitibant- low dose	Single intra-articular injection of low dose of fasitibant
DRUG	Fasitibant- intermediate dose	Single intra-articular injection of intermediate dose of fasitibant
DRUG	Fasitibant- high dose	Single intra-articular injection of high dose of fasitibant
DRUG	Placebo comparator	Single intra-articular injection of placebo

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-07-31
• Last updated: 2015-11-03
• Results posted: 2015-09-16

Locations

25 sites across 4 countries: United States, Czechia, Germany, Italy