Single Injection of REGN475/SAR164877 in Treatment of Vertebral Fracture Pain

Regeneron Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Back Pain

Treatments: Drug: REGN475/SAR164877; Drug: Placebo (for REGN475/SAR164877)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01001715

ACT11308

Details and patient eligibility

About

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

Secondary objectives were:

• to assess the safety and tolerability of REGN475/SAR164877 in patients with vertebral fracture pain;
• to characterize the pharmacokinetic and immunogenicity profiles of REGN475/SAR164877 in this population.

Full description

The duration of the study period for each participant was up to 13 weeks, including a screening period up to 5 days, and 12-week follow-up after the injection.

Enrollment: 41 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe pain due to non-traumatic vertebral fracture associated with osteoporosis.

Exclusion criteria

• Mild pain score on the Pain Intensity-Numeric Rating Scale [PI-NRS] at screening and randomization visits;
• Narcotic addiction;
• Post-fracture vertebral instability;
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 2 patient groups, including a placebo group

REGN475/SAR164877

Experimental group

Description:

REGN475/SAR164877, single injection, dose depending on the participant's body weight

Treatment:

Drug: REGN475/SAR164877

Placebo

Placebo Comparator group

Description:

Placebo (for REGN475/SAR164877), single injection

Treatment:

Drug: Placebo (for REGN475/SAR164877)