Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)
Status:
Not yet recruiting
Trial end date:
2025-09-30
Target enrollment:
Participant gender:
Summary
This is a multicenter, Phase 3, randomised, double-blind, placebo-controlled study, which
aims to evaluate the efficacy and safety of the investigational drug emactuzumab for the
treatment of patients with localized or diffuse TGCT where surgical removal of the tumor is
not viewed as an option.
The study consists of two parts. In Part 1, eligible subjects will be assigned in a 2:1 ratio
to receive either emactuzumab or matching placebo in a double-blind fashion, that will be
administered in total 5 times as an intravenous (i.v.) infusion once every 2 weeks. This will
be followed by an observation period of 3 months leading to a total duration of 24 weeks in
Part 1. A number of assessments will be carried out during the course of the study, including
physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires.
Part 2 is a long-term double-blind follow-up phase of the subjects on emactuzumab or placebo.
Subjects assigned to placebo in Part 1 have the option to crossover under certain
circumstances to receive open-label emactuzumab in Part 2.