An open label multicenter phase 2 study for the initial evaluation of the tolerability of Birch pollen extract in patients suffering from atopic eczema and clinical relevant IgE-mediated sensitization against birch pollen.
- Conditions
- Atopic eczema and clinical relevant IgE-mediated sensitisation against birch pollenMedDRA version: 9.1Level: LLTClassification code 10003641Term: Atopic eczema
- Registration Number
- EUCTR2007-004876-38-DE
- Lead Sponsor
- ETI Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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. Women of child-bearing age employing sufficient contraceptive measurements
4. Patients have to suffer from atopic eczema
5. Patients have to suffer from clinical relevant IgE-mediated sensitisation against birch pollen assessed by:
- specific IgE against birch pollen CAP RAST > 3
- positive atopy patch test for birch pollen*
- positive skin prick test for birch pollen**
6. The diagnosis AE has to be verified according to the criteria of Hanifin and Rajka.
7. Duration of atopic eczema > 2 years
8. Total SCORAD > 25 at Screening Visit
* only in selected study centers, optional but not used as inclusion criterion
** if not performed within 3 month prior to screening-visit
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
Disease specific 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 Immunotherapy with birch pollen
2. The following therapy is not allowed 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 others than basic medication Urbason
· 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 (locally and systematically)
· Treatment with substances interfering with the immune system
· Treatment with tranquillizer or psychoactive drugs
5. Patients with therapeutically uncontrolled atopic eczema or erythrodermia
Patients with other known concomitant diseases / treatments
7. Active tuberculosis
8. Acute and chronic inflammatory or infectious diseases at the target organ
9. Advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis)
10. Immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
11. Immune deficiencies
12. Uncontrolled asthma, defined as FEV1 or PEF = 70% of predicted normal value
13. Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism)
14. Cardiovascular insufficiency or any severe or unstable pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; hematologic disorder; any other clinically significant medical condition that could increase the risk to the study participant
15. Malignant disease of any kind during the previous 5 years
16. Abnormal laboratory parameters and vital signs that could increase the risk to the study participant
17. Alcohol, drug or medication abuse within the past year
18. Severe psychiatric or neurologic disorders
Others
19. Patients who are expected to be non-compliant and/or not co-operative
20. Participation in any other clinical study within the last 30 days prior to the start of the study
21. Patients who have already participated in this study
22. Patients who are employees at the investigational site, relatives or spouses of the investigator
23. Any donation of germ cells, blood, organs, or bone marrow during the course of the study
24. Patients who are not contractually capable
25. Patients who are detained in an institution due to regulatory or judicially instruction
Special restrictions for female patients
26. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation
27. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >4
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method