NCT05417789

Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)

A Phase III, Multicentre, Randomised, Double-Blind Study to Assess the Safety and Efficacy of Emactuzumab vs. Placebo in Subjects With Tenosynovial Giant Cell Tumour

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: SynOx Therapeutics Limited · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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, subject to eligibility, to crossover to receive open-label emactuzumab in Part 2. Subjects assigned to active drug in Part 1 have the option to receive open-label retreatment under certain circumstances.

Conditions

• TGCT

Interventions

Type	Name	Description
DRUG	Emactuzumab	Emactuzumab administered once every 2 weeks (q2w)
DRUG	Placebo	Matching placebo administered once every 2 weeks (q2w)

Timeline

• Start date: 2024-10-09
• Primary completion: 2025-12-23
• Completion: 2027-09-30
• First posted: 2022-06-14
• Last updated: 2026-02-02

Locations

48 sites across 13 countries: United States, Austria, Belgium, Canada, France, Italy, Netherlands, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study