Systemic mastocytosis – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Fri, 12 Jun 2026 11:14:12 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Systemic mastocytosis – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Study on Dupilumab and Fexofenadine for Treating Indolent Systemic Mastocytosis with Skin Involvement in Patients https://clinicaltrials.eu/trial/study-on-dupilumab-and-fexofenadine-for-treating-indolent-systemic-mastocytosis-with-skin-involvement-in-patients/ Wed, 29 Apr 2026 15:02:48 +0000 https://clinicaltrials.eu/trial/study-on-dupilumab-and-fexofenadine-for-treating-indolent-systemic-mastocytosis-with-skin-involvement-in-patients/ This clinical trial is focused on studying the effects of a medication called dupilumab in treating a condition known as indolent systemic mastocytosis with skin involvement. Indolent systemic mastocytosis is a disease where certain cells in the body, called mast cells, build up in the skin and other parts of the body, causing symptoms like itching, skin lesions, and sometimes more severe reactions. The study will compare the effects of dupilumab, which is given as an injection, with a standard treatment using fexofenadine, a common antihistamine taken as a tablet.

The purpose of the study is to see how well dupilumab works compared to fexofenadine in reducing symptoms such as skin lesions, itching, and improving the overall quality of life for people with this condition. Participants in the study will receive either dupilumab or fexofenadine over a period of time, and their symptoms will be monitored to assess the effectiveness of the treatments. Some participants may also receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments.

The study will last for several months, during which participants will have regular check-ups to monitor their symptoms and any changes in their condition. The goal is to gather information on how these treatments can help manage the symptoms of indolent systemic mastocytosis and improve the quality of life for those affected by this disease. This research could provide valuable insights into better treatment options for people living with this condition.

]]> Study of Avapritinib for Adults with Systemic Mastocytosis Who Previously Participated in an Avapritinib Study https://clinicaltrials.eu/trial/study-of-avapritinib-for-adults-with-systemic-mastocytosis-who-previously-participated-in-an-avapritinib-study/ Wed, 29 Apr 2026 14:58:33 +0000 https://clinicaltrials.eu/trial/study-of-avapritinib-for-adults-with-systemic-mastocytosis-who-previously-participated-in-an-avapritinib-study/ This clinical trial focuses on a condition known as Systemic Mastocytosis, which is a rare disorder where there is an abnormal accumulation of mast cells in various parts of the body. The study involves a medication called Avapritinib, also known by its code name BLU-285. Avapritinib is provided in the form of a film-coated tablet and is taken orally.

The purpose of this study is to allow patients who have previously participated in an Avapritinib clinical study to continue receiving the medication until it becomes commercially available. This is intended for patients who have been benefiting from the treatment, as determined by their doctor. The study is open-label, meaning both the researchers and participants know what treatment is being administered.

Participants in this study will continue to take Avapritinib as they did in their previous study. The study will last until the medication is commercially available, or until the participant no longer benefits from the treatment. This trial is designed to ensure that patients who have shown positive results with Avapritinib can maintain their treatment without interruption.

]]> Study of BLU-263 and Azacitidine for Patients with Advanced Systemic Mastocytosis and Other KIT Altered Blood Cancers https://clinicaltrials.eu/trial/study-of-blu-263-and-azacitidine-for-patients-with-advanced-systemic-mastocytosis-and-other-kit-altered-blood-cancers/ Wed, 29 Apr 2026 14:30:36 +0000 https://clinicaltrials.eu/trial/study-of-blu-263-and-azacitidine-for-patients-with-advanced-systemic-mastocytosis-and-other-kit-altered-blood-cancers/ This clinical trial is focused on studying treatments for certain blood-related diseases, specifically those involving changes in a gene called KIT. The diseases being studied include Advanced Systemic Mastocytosis and other related blood cancers. The trial is testing a medication called Elenestinib (BLU-263), which is being evaluated both on its own and in combination with another drug called Azacitidine. Azacitidine is a medication that is typically used to treat certain types of blood disorders and cancers.

The purpose of the study is to determine the best dose of BLU-263 when used alone and when combined with Azacitidine, as well as to assess the safety and effectiveness of these treatments. The study is divided into two parts: one part involves taking BLU-263 by itself, and the other part involves taking BLU-263 together with Azacitidine. Participants will receive the medication either as a tablet taken by mouth or as an injection under the skin or into a vein, depending on the treatment plan.

Throughout the study, participants will be monitored to see how their bodies respond to the treatment, including any side effects they may experience. The study aims to gather information on how well the treatments work in managing the diseases and improving the health of the participants. The trial is expected to continue until 2030, allowing researchers to collect comprehensive data on the long-term effects and benefits of the treatments.

]]> Study on the Safety and Effectiveness of CGT9486 for Patients with Nonadvanced Systemic Mastocytosis https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-cgt9486-for-patients-with-nonadvanced-systemic-mastocytosis/ Wed, 29 Apr 2026 14:24:46 +0000 https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-cgt9486-for-patients-with-nonadvanced-systemic-mastocytosis/ This clinical trial is focused on studying a condition known as Systemic Mastocytosis, specifically its nonadvanced forms, which include Indolent Systemic Mastocytosis and Smoldering Systemic Mastocytosis. These are conditions where certain immune cells, called mast cells, build up in the body and can cause various symptoms. The study is testing a treatment called CGT9486, also known as bezuclastinib, which is a type of medication that targets specific proteins involved in the disease process. This medication is taken orally in the form of a tablet.

The purpose of the study is to evaluate the safety and effectiveness of CGT9486 compared to a placebo in patients with nonadvanced systemic mastocytosis. The study is divided into three parts. In the first part, the goal is to determine the best dose of bezuclastinib for patients. The second part aims to assess how well the medication works at the chosen dose compared to a placebo. The third part focuses on understanding the safety and how well patients tolerate the medication.

Participants in the study will take the medication or placebo for a period of time, and their health will be monitored to see how they respond to the treatment. The study will look at changes in symptoms and any side effects that may occur. The overall duration of the study is planned to last until 2026, with the aim of gathering comprehensive data on the treatment’s impact on the condition.

]]> Study of Avapritinib for Patients with Indolent Systemic Mastocytosis Not Adequately Managed by Standard Therapy https://clinicaltrials.eu/trial/study-of-avapritinib-for-patients-with-indolent-systemic-mastocytosis-not-adequately-managed-by-standard-therapy/ Wed, 29 Apr 2026 14:23:11 +0000 https://clinicaltrials.eu/trial/study-of-avapritinib-for-patients-with-indolent-systemic-mastocytosis-not-adequately-managed-by-standard-therapy/ This clinical trial is focused on studying a condition called Indolent Systemic Mastocytosis (ISM), which is a type of disease where certain cells in the body, known as mast cells, grow uncontrollably and cause various symptoms. The trial is testing a medication called Avapritinib, which is a type of drug known as a tyrosine kinase inhibitor. This medication is designed to target specific mutations in the KIT gene that are often found in patients with ISM. The study also involves the use of a placebo, which is a substance with no active medication, to compare the effects of Avapritinib.

The purpose of the study is to evaluate the safety and effectiveness of Avapritinib in patients with ISM whose symptoms are not adequately controlled with standard treatments. The study is divided into three parts. In the first part, the appropriate dose of Avapritinib will be determined. The second part will compare the change in symptoms from the start of the study to a specific point in time between those taking Avapritinib and those taking a placebo. The third part will assess the long-term safety and effectiveness of Avapritinib in these patients.

Participants in the study will take Avapritinib in the form of film-coated tablets, which are taken orally. The study will monitor changes in symptoms, the burden of mast cells in the body, and the overall quality of life of the participants. Safety will be closely monitored through regular assessments, including checking vital signs, conducting electrocardiograms (ECGs), and performing laboratory tests. The study aims to provide valuable information on how well Avapritinib works in managing ISM and its long-term safety for patients.

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