Moderate to severe atopic eczema with or without rhinitis and/or rhinoconjunctivitis caused by clinical relevant IgE-mediated sensitization against House dust mites (HDM) leading to aggravation of patient’s skin lesions. MedDRA version: 8.1 Level: LLT Classification code 10003641 Term: Atopic eczema
Conditions
Interventions
Trade Name: Depigoid
Product Name: Depigoid Milben Mix
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NA
CAS Number: NA
Other descriptive name: NA
Concentration unit: ml millilitre(s
Sponsors
LETI Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients of both gender aged from 18 up to 65 years 2.Prior to study specific examinations the patient has to give his/her written informed consent 3.At least 2 exacerbations of eczema or permanent skin lesions during the last 2 months 4.Patients have to suffer from atopic eczema (with or without rhinitis and/or rhinoconjunctivitis) impaired by clinical sensitization against House dust mites (HDM) leading to an aggravation of skin lesions. The sensitization against House dust mites (HDM) has to be verified by* ·Symptom aggravation of skin lesions by exposure to House dust mites (HDM) and during winter season ·A positive skin prick test for Dermatophagoides pteronyssinus (Der p) and/or Dermatophagoides farinae (Der f), resulting in a wheal diameter of at least 4 mm > negative control reaction or '++' versus histamine ·Specific IgE for Der p or Der f CAP-RAST > 3 5.The diagnosis atopic eczema has to be verified according to the criteria of Hanifin and Rajka 6.Duration of atopic eczema > 5 years 7.Encasings of bedding and mattress for more than 6 months (or stable environmental control) *Additionally an atopy patch test with Der p and Der f will be performed in selected study sites but not be used as inclusion criterion 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.The following therapy is not allowed within the last 5 years prior to screening as well as during the study and will prevent the patient from being included into the study: ·Specific Immunotheraphy with House dust mites (HDM) 2.The following therapy is not allowed within within 3 months prior to screening as well as during the study and will prevent the patient from being included into the study: ·Photopheresis 3.The following medications and therapies are not allowed within the last month prior to screening as well as during the study and will prevent the patient from being included into the study: ·Immunosuppressive agents (cyclosporins, mycophenolates) ·Systemic corticosteroids ·UV-therapy, tanning 4.The following medications and therapies are not allowed during the entire study and will lead to the patient being withdrawn: ·b-blocker ·Treatment with substances interfering with the immune system 5.Total SCORAD 40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or hysterectomy or are u
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is the comparison of the efficacy and tolerability of Depigoid House dust mites (HDM) extract versus placebo in a subcutaneous immuno-therapy over 18 months in patients with moderate to severe atopic eczema with or without rhinitis and/or rhinoconjunctivitis caused by clinical relevant IgE-mediated sensitization against House dust mites (HDM) leading to aggravation of patient’s skin lesions. For the comparison of efficacy between Depigoid House dust mites (HDM) and Pla-cebo a hierarchical test procedure will be applied. The primary objective will be evaluated by assessment of the following criteria: 1)the AUC (area under the Total SCORAD curve) over the 18 months time of treatment, 2)the medication consumption/basic medication (cumulative intake) over the 18 months time of treatment. ;Secondary Objective: ·Onset of efficacy · Number of atopic exacerbations ·Time to and severity of atopic exacerbations ·Quality of life questionnaire using the Dermatology Life Quality Index (DLQI) ·Specific IgG1, IgG4 and IgE against Der p and Der f ·Adverse events ·Laboratory ·Vital signs ·Global evaluation of safety;Primary end point(s): For the comparison of efficacy between Depigoid House dust mites (HDM) and Pla-cebo a hierarchical test procedure will be applied. The primary objective will be evaluated by assessment of the following criteria: 1)the AUC (area under the Total SCORAD curve) over the 18 months time of treatment, 2)the medication consumption/basic medication (cumulative intake) over the 18 months time of treatment. | — |
Countries
Germany
Outcome results
None listed