Purpose of this Study
We are doing this study to test how effectively a drug called emactuzumab works to reduce tumor size in people with tenosynovial giant cell tumors (TGCT).
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with biopsy-confirmed local or diffuse TGCT
- Do not have metastatic TGCT or disease that affects multiple joints
- Have not been treated with any systemic therapy (investigational or approved) that targets CSF-1 or CSF-1R within 3 months of joining the study
Age Range
18-100
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you agree to take part in this study, you will get a random assignment to a study drug group, which means that the study drug group you will be in is selected by chance (like rolling dice). In this study, for every 2 people who will receive emactuzumab, 1 person will receive placebo (2:1 ratio). A placebo is an inactive substance that has no drug in it.
Study participants will get the study drug every 2 weeks for approximately 10 weeks. A needle will be inserted into a blood vessel and connected to an intravenous infusion containing the study drug or placebo. The infusion will last for about 1.5 hours.
A scan called magnetic resonance imaging (MRI) will be arranged every 6 weeks after Day 1 for the first 6 months, then every 8 weeks for the next 6 months, and then every 12 weeks for the remainder of the study to assess your tumor(s) size. The "range of movement" (how far your joint moves) of your affected joint will be assessed by a qualified physiotherapist or other qualified healthcare professional.
The total number of visits in the study may be more than 15 if you take part in the open-label part, but your participation in the study will not last longer than 2 years.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
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
Principal Investigator
Richard
Riedel
Protocol Number
PRO00116073
NCT ID
NCT05417789
Phase
III
Enrollment Status
Pending Open to Enrollment