Patient Research
Sign in
All studies
Enrolling by invitationPHASE2INTERVENTIONAL

An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis

This research study, called an "open-label extension study," is for people with lung sarcoidosis, whether it affects only their lungs or other body parts too. The new medicine being tested is XTMAB-16. If you've already taken part in an earlier study (XTMAB-16-201) and completed its main parts, you might be able to join this one. The main goal is to check the long-term safety of XTMAB-16 and see how well it continues to work over time. Doctors will be looking at its effects on your sarcoidosis and making sure it's still safe for you to take. Everyone in this study will receive the active medicine, XTMAB-16.

At a glance

Status
Enrolling by invitation
Phase
PHASE2
Sponsor
Xentria, Inc.
Enrolment target
94
Start
01 Mar 2024
Estimated completion
01 Jan 2029
Pulmonary Sarcoidosis

What is this study about?

This study is an extension of previous research into a new medicine called XTMAB-16 for a condition known as pulmonary sarcoidosis. Pulmonary sarcoidosis is a disease where tiny clumps of inflammatory cells, called granulomas, grow in your lungs. These clumps can cause breathing problems and other symptoms. In some people, sarcoidosis can also affect other parts of the body, not just the lungs.

The main purpose of this particular study is to learn more about XTMAB-16's long-term safety and how well its positive effects last over time. It's called an "open-label" study because everyone who takes part will be given the actual medicine, XTMAB-16. This is different from some other studies where people might get a dummy treatment (placebo). We want to see if the medicine continues to be a good option for people living with sarcoidosis.

Understanding the long-term safety and how well a medicine works is very important for doctors and patients. It helps doctors decide the best ways to treat sarcoidosis and gives patients confidence in their treatment options. This study aims to provide that crucial information by following participants for a longer period.

Key takeaways

  • This study continues to look at a new medicine, XTMAB-16, for lung sarcoidosis.
  • It aims to check long-term safety and how well the treatment keeps working.
  • Only people from a previous XTMAB-16 study (XTMAB-16-201) can join.
  • All participants will receive the active medicine, XTMAB-16.
  • It's for adults aged 18 to 80 with sarcoidosis in the lungs, with or without involvement elsewhere.

Who may be eligible?

This study is open to both men and women between the ages of 18 and 80.

To join, you must have already taken part in an earlier study for XTMAB-16 (either study XTMAB-16-201 Part A or Part B) and have completed the main assessments in that study. If you're taking steroids for your sarcoidosis, your dose needs to have been steady for at least two weeks before you join this new study.

You cannot join if you had serious side effects in the previous study that meant you had to stop treatment, or if the treatment wasn't working for you in the previous study. Also, if you are pregnant, breastfeeding, or planning to become pregnant during the study, you won't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 18 and 80 years old?
  2. Have you already completed the main part of the XTMAB-16-201 study?
  3. If you take steroids for sarcoidosis, has your dose been steady for at least two weeks?
  4. Are you NOT pregnant, breastfeeding, or planning to become pregnant during the study?
  5. Did you NOT have to stop the previous XTMAB-16 study due to serious side effects or because the treatment wasn't working?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be continuing treatment with XTMAB-16. You'll have regular visits with the study team, likely at your usual clinic or hospital, to monitor your health and the effects of the medicine. These visits will involve various health checks, and possibly blood tests or other assessments to see how you're responding and to check for any side effects. You'll continue taking XTMAB-16 according to a schedule decided by the study doctors. The study aims to follow participants for an extended period to gather long-term information, and the exact duration of your participation will be discussed with you.

Potential risks and benefits

Taking part in this study means you could potentially benefit by continuing to receive supervised treatment with XTMAB-16, which may help manage your pulmonary sarcoidosis. However, there are always potential risks with any medicine, including side effects, some of which might be serious. The study team will carefully monitor you for these. You will be given a document that lists all known and potential risks. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Xentria Investigative Site
    Verified postcode
    Denver, United States
  • Xentria Investigative Site
    Verified postcode
    Chicago, United States
  • Xentria Investigative Site
    Verified postcode
    Greenville, United States
  • Xentria Investigative Site
    Verified postcode
    Cincinnati, United States
  • Xentria Investigative Site
    Verified postcode
    Philadelphia, United States
  • Xentria Investigative Site
    Verified postcode
    Prague, Czechia
  • Xentria Investigative Site
    Verified postcode
    Bielsk Podlaski, Poland
  • University Hospitals Coventry and Warwickshire NHS Trust
    Verified postcode
    Coventry, United Kingdom
  • King's College Hospital NHS Foundation Trust
    Verified postcode
    London, United Kingdom
  • Norfolk and Norwich University Hospitals NHS Foundation Trust
    Verified postcode
    Norwich, United Kingdom
  • NHS Tayside
    Verified postcode
    Perth, United Kingdom

Common questions

What is sarcoidosis?

Sarcoidosis is a condition where small lumps, called granulomas, grow in different parts of your body. It most commonly affects the lungs (pulmonary sarcoidosis) but can affect other organs too.

What is XTMAB-16?

XTMAB-16 is the name of the new medicine being tested in this study to treat sarcoidosis. It's hoped to help manage the condition.

What does 'open-label' mean?

'Open-label' means that everyone taking part in the study will know they are receiving the actual medicine, XTMAB-16, rather than a dummy treatment.

Why is this study important?

This study is important because it helps us understand if XTMAB-16 is safe and effective over a longer period, which is crucial for new treatments.

Will I have to pay to be in the study?

No, you will not have to pay for the XTMAB-16 medicine or the study-related visits and tests when you take part in a clinical trial.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "An Open-label Extension Study of XTMAB-16 in Patients With P…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.