Study on the Effects of XTMAB-16 and Prednisolone in Patients with Pulmonary Sarcoidosis with or without Other Body Involvement

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What is this study about?

This clinical trial is focused on studying pulmonary sarcoidosis, a condition that affects the lungs and can sometimes involve other parts of the body. The study is testing a new treatment called XTMAB-16, which is given as a solution through an intravenous infusion. The purpose of the study is to evaluate the safety and effectiveness of XTMAB-16 in reducing the need for oral corticosteroids, such as prednisolone, which are commonly used to manage symptoms of sarcoidosis.

Participants in the study will receive either XTMAB-16 or a placebo, which looks like the treatment but does not contain the active ingredient. The study is divided into two parts. In the first part, the focus is on determining the safe dosage levels of XTMAB-16. In the second part, the study will assess how well XTMAB-16 works in reducing the use of corticosteroids. Throughout the study, participants will be monitored for any side effects and changes in their condition.

The study aims to find out if XTMAB-16 can help patients with pulmonary sarcoidosis by allowing them to reduce their reliance on corticosteroids, which can have significant side effects when used long-term. The trial will also gather information on how the body processes XTMAB-16 and its impact on various health markers. This research could lead to new treatment options for those living with this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current medications.

A physical examination is performed, and specific tests are conducted to ensure the participant meets the study criteria.

2 baseline measurements

Baseline measurements are taken to establish a starting point for the study. These include lung function tests and quality of life assessments.

Blood samples are collected to measure specific biomarkers and to check for any existing antibodies.

3 part a treatment

Participants receive multiple ascending doses of XTMAB-16 through an intravenous infusion. The dosage and frequency are adjusted based on safety and tolerability.

Participants continue their current oral corticosteroid treatment, such as prednisone, at a dose of 7.5 to 25 mg per day.

4 monitoring and assessments

Regular monitoring is conducted to assess safety and any side effects. This includes checking for adverse events and changes in health status.

Participants undergo periodic blood tests to evaluate the body’s response to the treatment and to measure drug levels.

5 part b treatment

Based on results from Part A, participants receive the recommended dose of XTMAB-16 to evaluate its effectiveness in reducing corticosteroid use.

The goal is to achieve a reduced dose of corticosteroids, ideally reaching 5 mg of prednisone per day or equivalent by week 12.

6 final assessments

At the end of the study, final assessments are conducted to evaluate the overall effectiveness and safety of the treatment.

Participants complete questionnaires to assess changes in quality of life and lung function.

Who Can Join the Study?

Participant must be between 18 to 80 years old.
The study doctor believes the participant can understand and follow the study requirements.
Participant must weigh between 45 kg and 160 kg (99 to 353 lbs) at the start of the study.
Participant must have been diagnosed with pulmonary sarcoidosis at least 6 months before the study starts. This diagnosis should follow specific guidelines and rule out other similar diseases. Involvement of skin and eyes is allowed.
Participant must have a score of 1 or higher on the Modified Medical Research Conference (mMRC) Dyspnea Scale, which measures breathlessness.
Participant must be taking 7.5 to 25 mg per day of oral prednisone (or an equivalent medication) during the screening period and be able to follow a specific plan to reduce this medication as part of the study.
Participant must have been taking certain medications like methotrexate, azathioprine, mycophenolate, leflunomide, chloroquine, or hydroxychloroquine for at least 3 months before the study starts, and the dose should be stable for 4 weeks before the study starts. Efforts should be made to keep this medication stable during the study.
For Part A of the study only: Participant must be willing to avoid eating grapefruit or drinking grapefruit juice, as well as other similar fruits, from the start of the study until after the last dose of the study medication.
Participant must test negative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using a PCR or rapid antigen test at the start of the study.
Participant must be able to provide written consent to join the study.

Who Cannot Join the Study?

Patients who do not have pulmonary sarcoidosis (a condition affecting the lungs) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have a history of allergic reactions to similar medications cannot participate.
Patients who are pregnant or breastfeeding cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Fakultni Thomayerova nemocnice	Prague	Czechia
Virgen del Rocío University Hospital	Sevilla	Spain
Odense University Hospital	Odense	Denmark
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Aalborg University Hospital	Aalborg	Denmark
University Hospital Olomouc	Olomouc	Czechia
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
University General Hospital Of Heraklion	Heraklion	Greece
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Centrum Medycyny Oddechowej Mroz Sp. j.	Bialystok	Poland
Multimedica S.p.A.	Milan	Italy
General Hospital Of Corfu Agia Eirini	Corfu	Greece
Thoracic General Hospital Of Athens I Sotiria	Athens	Greece
Zealand University Hospital	Koege	Denmark
Ospedale “Morgagni – Pierantoni” di Forlì	Forli'	Italy
Hslzegvi Vdqk dtbcmblp	Barcelona	Spain
Aritlin Oytysxatgha Uxsgfcyotkzor Sjcsch	Siena	Italy
Akxvrd Utqsaieagu Hdyabrvr	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Czechia	Not yet recruiting	11.09.2023
Denmark	Not yet recruiting	11.09.2023
Greece	Not yet recruiting	11.09.2023
Italy	Not yet recruiting	11.09.2023
Poland	Not yet recruiting	11.09.2023
Spain	Not yet recruiting	11.09.2023

Trial locations

Investigated drugs:

XTMAB-16 is a medication being studied for its potential to help people with pulmonary sarcoidosis, a condition that affects the lungs and sometimes other parts of the body. The trial is looking at how safe and tolerable this medication is when given in increasing amounts. The goal is to find the best dose to use in future studies. Researchers are also checking if XTMAB-16 can help reduce the need for other medications, like oral corticosteroids, which are often used to manage sarcoidosis symptoms. This could mean fewer side effects for patients if XTMAB-16 proves to be effective.

Investigated diseases:

Sarcoidosis

Pulmonary sarcoidosis – Pulmonary sarcoidosis is a condition characterized by the growth of tiny collections of inflammatory cells, called granulomas, in the lungs. These granulomas can cause the lung tissue to become inflamed and may lead to scarring over time. The disease often begins with symptoms such as a persistent dry cough, shortness of breath, and chest pain. As the condition progresses, it can affect lung function, leading to difficulty in breathing and reduced oxygen levels in the blood. In some cases, sarcoidosis can also affect other organs, such as the skin, eyes, and lymph nodes, which is referred to as extrapulmonary manifestations. The exact cause of sarcoidosis is unknown, but it is believed to involve an abnormal immune response.

Trial ID:

2022-502877-41-00

Protocol code:

XTMAB-16-201

NCT ID:

NCT05890729

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Effects of XTMAB-16 and Prednisolone in Patients with Pulmonary Sarcoidosis with or without Other Body Involvement

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?