Mastocytosis is characterized by an excessive increase in the number of mast cells in different tissues. Symptoms result either from organ infiltration or frequently from the release of proinflammatory mast cell mediators. Whereas in cutaneous mastocytosis the increase in mast cell numbers is limited to the skin, systemic mastocytosis is characterized by multifocal lesions in the bone marrow and/or in various extracutaneous organs. MedDRA version: 12.1 Level: LLT Classification code 10052577 Te
Conditions
Interventions
Trade Name: RUPAFIN
Product Name: RUPAFIN
Pharmaceutical Form: Tablet
INN or Proposed INN: RUPATADINE
CAS Number: 158876825
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Allergie-Centrum-Charité
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Chronic stable symptomatic maculopapulous cutaneous mastocytosis or indolent systemic mastocytosis with skin involvement and a positive Darier's Sign - Age between 18 and 70 years - Female patients must be using a highly effective method of birth control (such as implants injectables, combined oral contraceptives, some IUDs, sexual abstinence, vasectomised partner), or they must be postmenopausal, surgically sterilised, or hysterectomised. - Voluntarily signed written informde consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - The presence of permanent severe diseases, especially those affecting the immune system, except for mastocytosis - History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia - History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy, hyper-/hypokalemia, bradycardia 440ms - Evidence of severe renal dysfunction (creatinine > 1,5 x upper reference value) - Evidence of significant hepatic disease (liver enzymes > 2 x upper reference value) - History of adverse reactions to RUP, or other ingredients of the IMP - Presence of active cancer which requires chemotherapy or radiation therapy - Aggressive systemic mastocytosis - History or presence of alcohol abuse or drug addiction - Participation in any clinical trial within 4 weeks prior to enrolment - Commitment to an institution in terms of 40 Abs. 1 Nr. 4 AMG - Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study - Intake of oral corticosteroids within 14 days prior to the beginning of the study - Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study - Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reduction of wheal and flare type skin reaction after standardised provocation testing assessed by volumetric and thermographic measurements;Secondary Objective: Improvement of additional related symptoms (e.g. pruritus) and subjective affliction as measured by physician and patient global assessments, DLQI, Itchy-QoL and VAS;Primary end point(s): The main goal of the analysis is to test whether treatment with 20 mg RUP is more effective in protecting mastocytosis patients from induced symptoms as compared to placebo. The primary efficacy parameter of the study is the assessment of wheal development by planimetric analyses of digital photographic imaging (time lapse) before and after treatment with study medication. | — |
Countries
Germany
Outcome results
None listed