The XTMAB-16-201 trial will test an investigational drug called XTMAB-16, a monoclonal antibody targeting the inflammatory response known to occur in patients living with sarcoidosis.
A single intravenous (IV) infusion of XTMAB-16 was studied in healthy adult participants at two different dose levels. Both dose levels were considered safe and well tolerated.
Sarcoidosis is a chronic, multisystem inflammatory disorder characterized by the presence of granulomas – tiny clumps of inflammatory cells. This rare disease can affect the skin, eyes, heart and central nervous system, with >90% of cases involving the lungs. While medications for systemic organ involvement often control this disease, some patients fail to respond to initial treatments and require additional targeted therapy, resulting in considerable costs and treatment burdens. This disease presents a significant unmet medical need and a highly important area of research and development.
About Investigational Drug
XTMAB-16 is a chimeric monoclonal antibody specific for TNFα. By blocking TNFα, XTMAB-16 may disrupt an important inflammatory pathway and help slow or stop granuloma formation.
Participants will receive XTMAB-16 or placebo through multiple intravenous (IV) infusions over a 12-24 week period.
The study is comprised of two parts. Participants enrolled in Part A will not participate in Part B of this study.
- Part A is a randomized double-blind placebo-controlled multiple dose-escalating study. Each cohort will enroll up to 8 participants (6 on XTMAB-16 and 2 on placebo).
- Part B is a randomized double-blind placebo-controlled proof of concept study. Up to 62 participants will be enrolled to receive XTMAB-16 or placebo (1:1).
Who is eligible to participate in the XTMAB-16-201 trial?
You may be eligible to take part in this trial if you:
- Are 18 years or older and were diagnosed with pulmonary sarcoidosis at least 6 months ago
- Are on a clinically stable dose of a corticosteroid for at least 4 weeks
- Have never taken a TNFα inhibitor in the past (requirement for Part A only)
For more information about taking part in the trial, please answer a few questions to connect with a clinical trial site near you.
Primary Outcome Measure
Safety and Tolerability: The level of risk to a participant and the degree to which an adverse event may affect day to day activities.
Secondary Outcome Measures
A participant’s immune response after exposed to a treatment over a period of time.
Profile that captures what the human body does to the treatment.
Selective biological markers that help measure disease progress or a participant’s response to a treatment.
Health-Related Quality Of Life
A participant’s individual perception of the impact of health, disease and treatment on their quality of life.
Trial Site Location
A list of trial sites that are actively recruiting can be found on the national clinical trials website.Clinical Trials Locations
XTMAB-16-201 Trial Site Visits
A variety of health information will be collected to see how you are responding to the investigational drug.
Health assessments to collect this information may very between visits but may include:
Frequently Asked Questions
Why Should I Participate?
There may or may not be a direct benefit to you as a result of taking part in this study. Your condition may remain the same, improve or could get worse. However, what is learned from the study may help in the development of better treatments for pulmonary sarcoidosis and may advance scientific knowledge. You may choose to participate for the chance to play an active role in your own clinical care or to gain access to a medical treatment before it is available to the wider public.
How Long Are The Visits?
If you participate in the study, you may have multiple IV infusions over a 12–24-week period. For certain visits you may be required to stay longer at the study site due to certain tests. The study site can give you more information about this. At the first screening visit you’ll be provided an informed consent form before any study procedures are done. At that first visit, your study doctor will check to see if you are able to take part in the study. This will involve completing some procedures and tests, including taking blood and urine samples. If you are able to take part in the study, you will be asked to come back for the additional visits and will have further procedures and tests. The screening period could take up to 6 weeks.
What Are The Possible Side Effects?
We do not know all the possible side effects of the study medicine. Like all medicines, the study medicine can cause side effects, although not everybody gets them. As a TNFα inhibitor, the study medicine may have risks similar to those reported with other similar TNFα inhibitors. The study medicine may also have side effects that are still unknown. If you participate in the study, your doctor will inform you if more information becomes available regarding side effects that may be related to the study medicine.
Will I Be Paid For Taking Part In This Study?
You will not receive any payment for taking part in the study. It is not expected to cost you to participate in the study. The study medicine will be provided to you free of charge and you will not be charged for any procedures performed for this study.
You may be reimbursed for reasonable expenses such as travel cost for attending the study visits, for example, parking. You’ll need to talk to the study doctor to find out about potential reimbursement available at the study site.
How Do I Find Out If I Can Join This Study?
You may want to discuss the study with your doctor so they can help you decide if this study could be right for you.