Study of XTMAB-16 and Prednisolone Sodium Phosphate for Patients with Pulmonary Sarcoidosis

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What is this study about?

This clinical trial is focused on studying a condition known as pulmonary sarcoidosis, which can sometimes affect other parts of the body beyond the lungs. The trial is testing a new treatment called XTMAB-16, which is given as a solution through an intravenous infusion. The study aims to understand how safe and effective this treatment is for people with pulmonary sarcoidosis, especially in reducing the need for oral corticosteroids, which are commonly used to manage the condition.

The trial is divided into two parts. In the first part, participants will receive different doses of XTMAB-16 to determine the safest and most effective dose for further study. The second part will focus on how well the treatment works in reducing the use of corticosteroids, such as Prednesol (a form of prednisolone), which is often used to control inflammation in sarcoidosis. Participants will be monitored for any side effects and changes in their condition throughout the study.

During the trial, some participants may receive a placebo, which looks like the treatment but does not contain the active ingredient. This helps researchers compare the effects of XTMAB-16 with no treatment. The study will also look at various health markers and quality of life measures to assess the overall impact of the treatment. The goal is to find a new way to manage pulmonary sarcoidosis that could potentially reduce the reliance on corticosteroids and improve patients’ quality of life.

1 joining the study

Upon joining the study, the participant will be assessed to ensure they meet the eligibility criteria. This includes being between 18 to 80 years old, having a diagnosis of pulmonary sarcoidosis for at least 6 months, and being on a stable dose of certain medications.

2 part a: safety and dosage evaluation

In Part A, the focus is on evaluating the safety and tolerability of the medication XTMAB-16. This involves receiving multiple ascending doses of the medication through an intravenous infusion.

Participants will also continue their current treatment with Prednesol 5mg Tablets taken orally, with a dosage of 7.5 to 25 mg per day, as determined by the investigator.

The goal is to determine the recommended dose level and frequency for the next phase of the study.

3 part b: efficacy evaluation

In Part B, the study aims to establish the effectiveness of XTMAB-16 in reducing the use of oral corticosteroids.

Participants will continue to receive XTMAB-16 and their corticosteroid dosage will be gradually reduced, aiming for a target dose of 5 mg per day by Week 12.

The effectiveness will be measured by the ability to maintain this reduced dose through Week 24.

4 monitoring and assessments

Throughout the study, participants will undergo regular monitoring to assess safety, including checking for any adverse effects.

Various health markers will be evaluated, such as levels of certain proteins and vitamins in the blood, to understand the impact of the treatment.

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

5 completion of the study

The study is expected to conclude by July 2026. Upon completion, participants will have a final assessment to evaluate the overall outcomes of the treatment.

Who Can Join the Study?

Participant must be between 18 to 80 years old.
The participant should be able to understand and follow the study requirements, as judged by the study doctor.
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 (a lung condition) at least 6 months before the study starts, following specific medical guidelines. Other similar diseases should be ruled out. Skin and eye involvement is allowed.
Participant must have a score of 1 or more 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 (a type of steroid) or an equivalent medication during the screening period and should be able to follow a specific plan to reduce this medication, as decided by the study doctor.
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 have been stable for 4 weeks before the study starts. Efforts should be made to keep the medication dose 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 SARS-CoV-2 (the virus that causes COVID-19) 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 have a different condition than pulmonary sarcoidosis with or without other body parts being affected cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Patients who are not male or female cannot participate.
Patients who are considered part of a vulnerable population cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Odense University Hospital	Odense	Denmark
Aalborg University Hospital	Aalborg	Denmark
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Centrum Medycyny Oddechowej Mroz Sp. j.	Bialystok	Poland
Multimedica S.p.A.	Milan	Italy
Fakultni Thomayerova nemocnice	Prague	Czechia
Zealand University Hospital	Koege	Denmark
Ospedale “Morgagni – Pierantoni” di Forlì	Forli'	Italy
Arkezci Okjzppxxfot Ucvqvsgmrulnd Sjkxfu	Siena	Italy
Aroxba Uiouoshtyv Hyfgxumk	Aarhus	Denmark
Hjhlnqfb Vgub dyhwxdlw	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	11.09.2024
Denmark	Recruiting	11.09.2024
Italy	Not yet recruiting	11.09.2024
Poland	Recruiting	11.09.2024
Spain	Recruiting	11.09.2024

Trial locations

Investigated drugs:

XTMAB-16 is an investigational medication being studied for its potential to treat pulmonary sarcoidosis, a condition that affects the lungs and sometimes other parts of the body. The study aims to evaluate the safety and tolerability of this medication when given in multiple doses. Researchers are also looking to determine the most effective dose and frequency for future studies. Additionally, the study will assess whether XTMAB-16 can help reduce the need for oral corticosteroids, which are commonly used to manage symptoms of sarcoidosis.

Investigated diseases:

Sarcoidosis

Pulmonary Sarcoidosis – Pulmonary sarcoidosis is a condition characterized by the growth of tiny clusters of inflammatory cells, known as granulomas, in the lungs. These granulomas can affect the normal structure and function of the lungs, leading to symptoms such as persistent dry cough, shortness of breath, and chest pain. The disease can progress with varying severity, sometimes remaining stable or even resolving on its own, while in other cases, it may lead to lung scarring and reduced lung function. Pulmonary sarcoidosis can also have extrapulmonary manifestations, affecting other organs like the skin, eyes, or lymph nodes. The exact cause of sarcoidosis is unknown, but it is believed to involve an abnormal immune response to an unknown trigger. The progression of the disease can vary greatly among individuals, with some experiencing mild symptoms and others facing more significant health challenges.

Trial ID:

2022-502877-41-01

Protocol code:

XTMAB-16-201

NCT ID:

NCT05890729

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of XTMAB-16 and Prednisolone Sodium Phosphate for Patients with Pulmonary Sarcoidosis

What is this study about?

Who Can Join the Study?

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