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ABOUT CLINICAL TRIAL GOALS INCLUSION/EXCLUSION CRITERIA WHAT WILL HAPPEN IN THIS TRIAL? FAQs
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A Clinical Trial to Evaluate Emactuzumab as a Treatment for People with Tenosynovial Giant Cell Tumor (TGCT)

This website informs, educates and supports patients, carers and healthcare professionals seeking to understand and manage Tenosynovial Giant Cell Tumour (TGCT), also known as pigmented villonodular synovitis (PVNS).

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A Clinical Trial to Evaluate Emactuzumab as a Treatment for People with Tenosynovial Giant Cell Tumor (TGCT)

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This website informs, educates and supports patients, carers and healthcare professionals seeking to understand and manage Tenosynovial Giant Cell Tumour (TGCT), also known as pigmented villonodular synovitis (PVNS).

About

TGCT

TGCT is a rare, locally aggressive tumor of the joint, tendon sheath, or bursae. TGCT can lead to joint damage, limited mobility, pain, and stiffness.

Symptoms of these tumors are often initially like those of other conditions, such as sports injuries or arthritis, which is why they may be difficult to diagnose and treat effectively. TGCT can affect nearly every aspect of a person’s daily life. Common everyday activities such as walking up and down stairs, shopping, and doing household chores can be difficult for people with TGCT.

There are 2 types of TGCT: diffuse TGCT, which is less common and more difficult to treat, and localized TGCT, which can often be treated with surgery, although some tumors can be difficult to remove fully and may grow back with time. TGCT is a rare disease. Researchers do not exactly know how many people are affected by TGCT, but it is estimated that only 43 out of every million people are diagnosed with TGCT each year worldwide.

TANGENT Clinical Trial

Phas 3 Clinical Trial Age 12 years & older

TANGENT is a Phase 3 clinical trial that aims to learn more about a novel drug called emactuzumab in development for the treatment of people with TGCT.

The TANGENT trial will include people aged 12 years or older with TGCT who are not eligible for surgery and who are experiencing a loss of mobility and reduced quality of life due to pain and stiffness caused by their TGCT.

You can learn more about the TANGENT clinical trial on the ClinicalTrials.gov website. You can search for the TANGENT clinical trial using this number: NCT05417789

EMACTUZUMAB

Emactuzumab is a type of drug called a monoclonal antibody. Monoclonal antibodies are man-made drugs that are designed to act like antibodies already present in our immune system.

Colony stimulating factor-1 (CSF-1) is a naturally occurring protein that can be overexpressed in patients with TGCT and can stimulate the growth of tumors in people with the disease. Emactuzumab is a novel monoclonal antibody developed to treat TGCT. It binds to the CSF-1 receptor, also called CSF-1R, thereby blocking the receptor and preventing CSF-1 from binding to it, inhibiting tumor growth in patients with TGCT.

Emactuzumab is an investigational drug. This means it is not yet approved for use by a government health agency or authority. It has been already investigated in patients with TGCT in other earlier-stage clinical studies, which demonstrated that emactuzumab had an acceptable safety profile and showed activity in TGCT patients.

TGCT

TGCT is a rare, locally aggressive tumour of the joint, tendon sheath or bursae. TGCT can lead to joint damage, limited mobility, pain and stiffness.

Symptoms of these tumours are often initially like those of other conditions, such as sports injuries or arthritis, which is why they may be difficult to diagnose and treat effectively. TGCT can affect nearly every aspect of a person’s daily life. Common everyday activities such as walking up and down stairs, shopping and doing household chores can be difficult for people with TGCT.

There are 2 types of TGCT: diffuse TGCT, which is less common and more difficult to treat, and localised TGCT, which can often be treated with surgery, although some tumours can be difficult to remove fully and may grow back with time. TGCT is a rare disease. Researchers do not exactly know how many people are affected by TGCT, but it is estimated that only 43 out of every million people are diagnosed with TGCT each year worldwide.

TANGENT
Clinical Trial

TANGENT is a Phase 3 clinical trial that aims to learn more about a novel drug called emactuzumab in development for the treatment of people with TGCT.

The TANGENT trial will include people aged 12 years or older with TGCT who are not eligible for surgery and who are experiencing a loss of mobility and reduced quality of life due to pain and stiffness caused by their TGCT.

You can learn more about the TANGENT clinical trial on the ClinicalTrials.gov website. You can search for the TANGENT clinical trial using this number: NCT05417789

Phase 3 Clinical Trial
Age 12 Years & Older

EMACTUZUMAB

Emactuzumab is a type of drug called a monoclonal antibody. Monoclonal antibodies are man-made drugs that are designed to act like antibodies already present in our immune system.

Colony stimulating factor-1 (CSF-1) is a naturally occurring protein that can be overexpressed in patients with TGCT and can stimulate the growth of tumours in people with the disease. Emactuzumab is a novel monoclonal antibody developed to treat TGCT. It binds to the CSF-1 receptor, also called CSF-1R, thereby blocking the receptor and preventing CSF-1 from binding to it, inhibiting tumour growth in patients with TGCT.

Emactuzumab is an investigational drug. This means it is not yet approved for use by a government health agency or authority. It has been already investigated in patients with TGCT in other earlier-stage clinical studies, which demonstrated that emactuzumab had an acceptable safety profile and showed activity in TGCT patients.

CLINICAL TRIAL GOALS

To learn whether emactuzumab helps tumours shrink in size or disappear better than a placebo (an identical-looking treatment that contains no active ingredients).

To confirm that emactuzumab is a safe treatment for TGCT.

To learn whether emactuzumab helps tumours shrink in size or disappear better than a placebo (an identical-looking treatment that contains no active ingredients).

To learn whether emactuzumab improves joint movement and reduces joint pain and stiffness better than a placebo.

To learn whether emactuzumab improves joint movement and reduces joint pain and stiffness better than a placebo.

Emactuzumab has already been tested in smaller clinical studies that were approved by competent authorities and ethical committees, which showed clinical activity of emactuzumab with an acceptable safety profile in patients with TGCT.

To confirm that emactuzumab is a safe treatment for TGCT.

Emactuzumab has already been tested in smaller clinical studies that were approved by competent authorities and ethical committees, which showed clinical activity of emactuzumab with an acceptable safety profile in patients with TGCT.

INCLUSION CRITERIA

Participants are eligible to be INCLUDED in the study if at least the following key criteria apply:

Be at least 12 years old

Have a confirmed diagnosis of TGCT and cannot undergo surgery for their disease

Have loss of mobility and overall lower quality of life due to pain and stiffness caused by TGCT

Be able to attend trial site visits and complete trial assessments

EXCLUSION CRITERIA

Participants are EXCLUDED from the study if at least the following key criteria apply:

Have TGCT that affects multiple joints or has spread to other parts of the body

Have certain medical conditions that might put them at a higher risk for side effects during the trial

Be taking certain medications that are not allowed during the trial

WHAT WILL HAPPEN IN THIS TRIAL

If you are interested in joining this trial, you will need to visit a trial site. A trial doctor will explain the trial to you. If you agree to join, the doctors and other site staff will give you an examination and ask you questions about your TGCT and your medical history to make sure the study is right for you. Read More

If you are interested in joining this trial, you will need to visit a trial site. A trial doctor will explain the trial to you. If you agree to join, the doctors and other site staff will give you an examination and ask you questions about your TGCT and your medical history to make sure the study is right for you.

During the trial, adult participants will be randomly assigned and you will receive either emactuzumab or a placebo (an identical-looking treatment with no active ingredients). About two-thirds of the adult participants will receive emactuzumab, and about one-third will receive a placebo. Adult participants who are randomised to the placebo arm will have a chance to cross over to the active emactuzumab arm after 6 months from start of initial treatment depending on the clinical situation as defined in the protocol. Neither the participants nor the trial site staff will know who is receiving the trial drug and who is receiving a placebo. Younger participants (under 18 years of age) will all receive emactuzumab.

Trial participants will receive their treatment as an intravenous infusion (through a needle in their vein) once every 2 weeks with a total of 5 administrations for a period of about 10 weeks.

Once you finish treatment, you will have follow-up visits at the trial site. You will visit the trial site monthly at first, then once every 3 months and then twice a year. It is estimated that each person who joins the trial will spend up to 2 years as a participant. If your TGCT gets worse during this time, you may be eligible for additional treatment with emactuzumab.

During follow-up visits, the trial doctors will monitor the size of your tumour using magnetic resonance imaging, also called an MRI. An MRI is a non-invasive scan that allows doctors to measure the size of a tumour. You will provide information about your symptoms and general health.
You can choose to leave the trial at any time. The trial doctor or sponsor also has the right to discontinue a participant for safety issues or if the participant no longer meets the trial requirements.

Frequently Asked Questions (FAQs)

What is a clinical trial?

Clinical trials help determine the safety and effectiveness of treatments in humans. A research plan, also called a protocol, is created before the trial starts. The protocol describes who can join the trial, what treatments the participants will receive, what questions the researchers will seek to answer, how long the trial will last, and how participant privacy and safety will be protected during the trial. A clinical trial may compare a new treatment to a standard treatment option that is already available, to a placebo (an identical-looking treatment with no active ingredient) or to no intervention at all. Participation in a clinical trial is voluntary. Trial participants should have the intention to complete the trial. Before you decide to join a clinical trial, the trial team will explain all of the trial details.

What is Tangent?

TANGENT is a Phase 3 clinical trial that aims to learn more about a novel drug called emactuzumab in development for the treatment of people with TGCT.

The TANGENT trial will include people aged 12 years or older with TGCT who are not eligible for surgery and who are experiencing a loss of mobility and reduced quality of life due to pain and stiffness caused by their TGCT.

You can learn more about the TANGENT clinical trial on the ClinicalTrials.gov website. You can search for the TANGENT clinical trial using this number: NCT#05417789.

What is a Phase 3 trial?

When new drugs are being studied as possible treatments for patients with a disease, they are tested in stages, or “phases.”

Phase 3 trials typically include large numbers of participants, often from multiple countries. Drugs studied in Phase 3 trials have already been studied in smaller trials. Earlier trials of emactuzumab helped researchers learn about its safety and tolerability, how effectively it works to treat people with the disease and the dose level at which it works best. If the outcomes of a Phase 3 trial are positive, the results can be used to apply for approval of a drug by health authorities.

What is emactuzumab?

Emactuzumab is a type of drug called a monoclonal antibody. Monoclonal antibodies are man made drugs that are designed to act like antibodies already present in our immune system.

Colony stimulating factor-1 (CSF-1) is a naturally occurring protein that can be overexpressed in patients with TGCT and can stimulate the growth of tumours in people with the disease. Emactuzumab is a novel monoclonal antibody developed to treat TGCT. It binds to the CSF-1 receptor, also called CSF-1R, thereby blocking the receptor and preventing CSF-1 from binding to it, inhibiting tumour growth in patients with TGCT.

Emactuzumab is an investigational drug. This means it is not yet approved for use by a government health agency or authority. It has been investigated in patients with TGCT in another earlier-stage clinical study, which demonstrated that emactuzumab had | an acceptable safety profile and showed activity in TGCT patients.

What is a placebo?

A placebo is a treatment that looks exactly like the trial drug but contains no active ingredients. In clinical trials, researchers often compare an investigational treatment with a placebo. All of the participants receive the same level of quality care, regardless of whether they are assigned to receive the investigational drug or the placebo – the only difference is whether they actually receive the trial drug. This helps researchers better evaluate the true effects of the drug.

How can I check to see if this trial could be right for me?

You can check if this trial could be right for you by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

Can I leave the trial at any time?

You have the right to drop out of the trial at any time for any reason or for no reason at all. The trial doctor or sponsor also has the right to discontinue a trial participant at any time for the participant’s safety, or if the participant no longer meets the trial requirements.

What personal information will be collected about me for the trial?

The trial doctor and other site staff will collect your personal information. All staff with access to your records are required to keep your data private. Personal information may include:

  • Your name, address, telephone number and health insurance number, where applicable
  • Your age, sex, and ethnic and racial background
  • Lifestyle information
  • Medical history details
  • Your trial treatments and your response to these treatments
  • Data resulting from testing your biological samples

How will my privacy be protected?

  • You will not be identifiable by your personal information, including your name.
  • Instead, a computer programme will assign you a unique code. You will be identified by that code only for the duration of the trial. In an emergency, the study doctor and certain staff will be able to connect this code to your name if necessary for your health and wellbeing.
  • Also, your name and other data that can identify you will NOT be attached to any records or samples sent to the study sponsor or its service providers.

Will it cost anything to take part in this trial?

No. All trial-related examinations, tests and trial medication are provided at no cost to participants. In addition, travel assistance may be provided if you need to travel to one of the trial clinics taking part in this clinical trial. Ask the site contact for more information.

Can I join this trial if I don’t have health insurance?

Yes. Health insurance is not required to participate.

Can I join this trial if the trial doctor is not part of my health insurance network?

Yes. You can join this trial even if your trial doctor is not part of your health insurance network. There is no cost to participate, and your insurance will not be billed

Will any individuals or entities other than the study staff and doctor have access to my personal information?

All of your personal information collected for this trial will be securely stored in the trial medical records at the trial site. Sponsor staff, review boards and ethics committees (that approve and monitor studies), and government agencies may check the trial records. This is done to make sure that the trial is being run properly. Regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify clinical trial procedures and/or data. If you share your personal data to contact a site, that data will be used by a dedicated person from the TANGENT team to contact you regarding this clinical trial and related information.

How can I learn more?

To lean more, you can ask your doctor for more information. You can also visit www.ClinicalTrials.gov and search for this trial. You can search for the trial using this number: NCT05417789.

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