Single Injection of REGN475/SAR164877 in the Treatment of Chronic Pancreatitis Pain

Randomized, Double-blind, Placebo-controlled Study of the Effect of a Single Injection of SAR164877 (REGN475) on Reduction of Pain From Chronic Pancreatitis

Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain associated with chronic pancreatitis.

Secondary objectives were:

• to assess the safety and tolerability of REGN475/SAR164877 in patients with chronic pancreatitis pain;
• to characterize the pharmacokinetic, pharmacodynamic, and immunogenicity profiles of REGN475/SAR164877 in this population;
• to measure the change in the total daily dose of rescue medications required.

The duration of the study period for each participant was up to 14 weeks, including a screening period up to 2 weeks, and 12-week follow-up after the injection.

Inclusion criteria:

• Moderate to severe abdominal pain due to chronic pancreatitis of at least 6 months duration.

Exclusion criteria:

• Mild pain on the Pain Intensity-Numeric Rating Scale [PI-NRS] at screening and randomization visits;
• Narcotic addiction;
• Recent pancreatic surgical or endoscopic intervention for chronic pancreatitis pain;
• Unwillingness to use study-defined rescue analgesia exclusively.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.