Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis, Knee Arthritis WOMAC Injections, intra-articular Fasitibant MEN 16132
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 436
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Drug: solution for intra-articular injection arm 2: Drug: solution for intra-articular injection arm 3: Drug: solution for intra-articular injection arm 4: Drug: solution for intra-articular injection

Interventions: intervention 1: Fasitibant- low dose intervention 2: Fasitibant- intermediate dose intervention 3: Fasitibant- high dose intervention 4: Placebo comparator
Intervention descriptions: intervention 1: Single intra-articular injection of low dose of fasitibant intervention 2: Single intra-articular injection of intermediate dose of fasitibant intervention 3: Single intra-articular injection of high dose of fasitibant intervention 4: Single intra-articular injection of placebo

Protocol document: