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The use of dupilumab in treatment of indolent systemic mastocytosis with skin involvement
EU CTIS ID: 2023-509111-89-00
What this study is testing
Compare the effects of treatment with dupilumab (the study drug) and fexofenadine (standard antihistamine treatment).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Diagnosis of systemic mastocytosis with a slow course according to WHO criteria and skin involvement of the above-mentioned. criteria • Age 18-65 lat • There is a moderate additional risk of a disease impairing the quality of life in 2 of 6 abnormalities: 1. Extent of skin lesions - % of skin function (BSA-Body Surface Area according to the Wallace 9 principles); importance of the impact of skin lesions (>=30% BSA) 2. Intensity of itching on the VAS scale assessment of this result on a scale of 0-10 points severe or severe itching >=3 on the VAS scale 3. Quality of life index of the MC-QoL questionnaire (symptoms causing with the release of mast cell mediators) MC-QoL score >=50 points 4. Severity of the score (Hamilton Rating Scale for Depression) Hamilton Rating Scale score >=19 5. Severity determines (Fatigue Impact Scale) Fatigue Impact Scale score >=75 points 6. Assessment of the quality of life of patients treated for hematologic disease using the European Organization for Research and Treatment of Cancer EORTC QLQ C30 questionnaire <= 83 points
You likely can't join if
- • Other cancer diseases, including one of the aggressive forms of mastocytosis, isolated cutaneous mastocytosis (without systemic mastocytosis). • Liver, kidney and heart failure, respiratory failure • Chronic infectious diseases and parasitic infections, pregnancy, lactation, lack of cooperation with the patient. • Exacerbation of chronic diseases. • Hypersensitivity to study drugs
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.