Musculoskeletal Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Wounds and Injuries

Nervous System Diseases

Rare Diseases

Synovitis

Giant Cell Tumors

Giant Cell Tumor of Tendon Sheath

Synovitis, Pigmented Villonodular

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Joint Diseases

Tendinopathy

Muscular Diseases

Pigmented Villonodular Synovitis

Group 1: Subjects receiving emactuzumab administered on Day(D)1 and repeated once every two weeks (Q2W) for a total of 5 times, followed by an observation period of 3 months leading to a total period of 24 weeks in Part 1 and continued with a follow-up phase in Part 2. Subjects assigned to active drug in Part 1 have the option to receive open-label retreatment under certain circumstances

Group 2: Subjects receiving placebo administered as iv infusion on D1 and repeated once every two weeks (Q2W) for 5 times followed by an observation period of 3 months to a total period of 24 weeks in Part 1 will have the option to crossover under certain circumstances to open-label emactuzumab once every 2 weeks (Q2W) for a total of 5 times in Part 2.

Emactuzumab administered once every 2 weeks (q2w)

Emactuzumab

Matching placebo administered once every 2 weeks (q2w)

Placebo

Clinical Team Synox

Jean Y Blay, Prof, MD

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. Subjects assigned to active drug in Part 1 have the option to receive open-label retreatment under certain circumstances.

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

Objective Response Rate (ORR = complete response \[CR\] + partial response \[PR\]) by 6 months from initiation of therapy according to RECIST v1.1 based on independent, blinded central review

Change in Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) TGCT from baseline to 6 months

Mean change from baseline in active ROM of the joint over time

Mean change from baseline in the Worst Stiffness Numeric Rating Scale (NRS) score over time

Mean change in Pain Numerical Rating Scale (NRS) from baseline over time

Change in EuroQol 5-dimension, 5-level questionnaire (EQ-5D-5L)

Duration of response (DoR) as measured by RECIST version 1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)	NCT05417789	TGCT	Emactuzumab Placebo	12 Years -	SynOx Therapeutics Limited
Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)	NCT05417789	TGCT	Emactuzumab Placebo	12 Years -	SynOx Therapeutics Limited

Spots Global Cancer Trial Database for tgct, tenosynovial giant cell tumour