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Study on Long-term Safety of XTMAB-16 for Patients with Pulmonary Sarcoidosis with or without Extra-pulmonary Involvement

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term effects of a treatment called XTMAB-16 for patients with pulmonary sarcoidosis. Pulmonary sarcoidosis is a condition where clusters of inflammatory cells, known as granulomas, form in the lungs, and it can sometimes affect other parts of the body. The treatment being tested, XTMAB-16, is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to evaluate the long-term safety and effectiveness of XTMAB-16 in managing pulmonary sarcoidosis, whether or not it involves other parts of the body. Participants in the study will receive the treatment over an extended period, and researchers will monitor them to see how well they tolerate the medication and how it affects their condition. The study will also look at various health measures, such as lung function and quality of life, to understand the overall impact of the treatment.

Throughout the study, researchers will keep track of any side effects or adverse events that participants may experience. They will also assess changes in the use of corticosteroids, which are often used to manage sarcoidosis symptoms, and measure certain biological markers in the blood that can indicate inflammation or disease activity. This information will help determine the long-term benefits and risks of using XTMAB-16 for treating pulmonary sarcoidosis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying completion of the previous study, XTMAB-16-201, and ensuring a stable steroid dose for at least two weeks prior to the start of this study.

  2. Step 2

    Medication administration

    The medication XTMAB-16 is administered as a solution for infusion through an intravenous route. The specific dosage and frequency are determined based on the participant's previous study cohort.

  3. Step 3

    Monitoring and assessments

    Throughout the study, regular monitoring is conducted to evaluate the rate of adverse events, including serious adverse events and those of special interest.

    Assessments include measuring the total corticosteroid dose over the first 12 weeks, changes in quality-of-life measures, and changes in pulmonary function tests.

    Biomarkers such as angiotensin converting enzyme, interleukin-6, and others are monitored for changes from baseline.

  4. Step 4

    Antibody testing

    Participants are tested for the presence of XTMAB-16 anti-drug antibodies and neutralizing antibodies to evaluate immune response to the medication.

  5. Step 5

    Study completion

    The study is estimated to conclude by November 26, 2028. Participants will undergo final assessments to evaluate the long-term safety and effectiveness of the treatment.

Who can join the trial?

5 criteria

  • The study is for people with **pulmonary sarcoidosis**, which is a condition affecting the lungs, and it can also affect other parts of the body.
  • Participants must have completed a previous study called **XTMAB-16-201**. This means they should have finished either 12 weeks (Part A) or 24 weeks (Part B) of that study.
  • Participants from the previous study should be taking a stable dose of **steroids** for at least 2 weeks before starting this new study. Steroids are medications that help reduce inflammation in the body.
  • The study is open to both men and women.
  • The study includes people who are considered part of a **vulnerable population**, which means they might need extra protection or care.

Who cannot join the trial?

9 criteria

  • Individuals who do not have a diagnosis of pulmonary sarcoidosis. Pulmonary sarcoidosis is a condition that affects the lungs and sometimes other parts of the body.
  • Individuals who are not within the specified age range for the study. The study is open to certain age groups only.
  • Individuals who are not able to follow the study procedures or attend the required visits.
  • Individuals who have other medical conditions that might interfere with the study or make participation unsafe.
  • Individuals who are pregnant or breastfeeding, as the study may not be safe for them or their babies.
  • Individuals who are currently participating in another clinical trial, as this could affect the results of the study.
  • Individuals who have a history of allergic reactions to the study medication or similar medications.
  • Individuals who have a history of substance abuse, as this could interfere with the study results.
  • Individuals who have certain mental health conditions that might affect their ability to participate in the study.
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Investigated drugs

XTMAB-16 is a medication being studied for its long-term safety and effectiveness in treating patients with pulmonary sarcoidosis. Pulmonary sarcoidosis is a condition where clusters of inflammatory cells form in the lungs, and this medication aims to help manage the symptoms and progression of the disease. The study is focused on understanding how well patients tolerate this medication over an extended period and how it affects their condition, whether they have additional symptoms outside of the lungs or not.

What is already known about the treatment

XTMAB-16 – This medication is administered through an injection, typically given under the skin. It is currently being studied in clinical trials to assess its long-term safety and effectiveness for treating pulmonary sarcoidosis, a condition that affects the lungs and may also involve other parts of the body. XTMAB-16 works by targeting specific proteins in the immune system to reduce inflammation and prevent the formation of granulomas, which are clusters of immune cells. It is classified as a monoclonal antibody, a type of medication designed to specifically target and neutralize certain molecules in the body.

Investigated diseases

Pulmonary Sarcoidosis – This is a condition characterized by the growth of tiny clusters of inflammatory cells, called granulomas, in the lungs. These granulomas can affect how the lungs function, leading to symptoms such as a persistent cough, shortness of breath, and chest pain. The disease can progress by causing lung tissue to become scarred and stiff, which may further impair breathing. In some cases, sarcoidosis can also affect other organs, such as the skin, eyes, or lymph nodes, leading to additional symptoms. The exact cause of sarcoidosis is unknown, but it is believed to involve an abnormal immune response. The progression of the disease varies widely among individuals, with some experiencing mild symptoms and others having more severe manifestations.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507590-18-00Protocol codeXTMAB-16-202Estimated enrolment94 patientsSponsorXentria Inc.

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