Contemporary Clinical Trials | VOL. 121
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Design of a randomized, placebo-controlled, phase 2 study evaluating the safety and efficacy of tanezumab for treatment of schwannomatosis-related pain

Publication Date Oct 1, 2022

Abstract

Schwannomatosis (SWN) is a rare tumor suppressor syndrome that predisposes affected individuals to develop multiple schwannomas and, less often, meningiomas. The most common symptom is chronic, severe pain. No medications are broadly effective in treating SWN-associated pain. The clinical trial described in this manuscript is a phase 2, randomized, double-blind, placebo-controlled study investigating the safety and efficacy of tanezumab - a humanized monoclonal antibody that inhibits nerve growth factor - for treatment of SWN-related pain. As the first therapeutic trial for SWN-related pain, it also aims to evaluate trial endpoints, understand recruitment patterns, and improve clinical trial design in this rare disease. The primary objective of this trial is to assess the analgesic efficacy of subcutaneous tanezumab 10mg in subjects with SWN who continue pre-existing pain therapy (excluding non-steroidal anti-inflammatory drugs). The secondary objective is to assess safety in this population. Exploratory objectives include assessment of pain features, quality of life, and predictive biomarkers. The study is comprised of four periods (pre-treatment, double-blind treatment, single-arm treatment, safety follow-up) across 10months with a delayed-start trial design to allow all participants to receive tanezumab. Forty-six participants will be enrolled and randomized 1:1 to receive either tanezumab or placebo subcutaneously in the double-blind treatment period; all participants receive tanezumab during the single-arm treatment per...

Concepts

Efficacy Of Tanezumab Inhibits Nerve Growth Factor Schwannomatosis Humanized Monoclonal Antibody Mg In Subjects Double-blind Treatment Period Single-arm Treatment Rare Disease Safety Follow-up Double-blind Treatment

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