E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Atopic eczema and clinical relevant IgE-mediated sensitisation against birch pollen |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003641 |
E.1.2 | Term | Atopic eczema |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of the study is the initial evaluation of the tolerability of Birch pollen extract in a subcutaneous immunotherapy over 3 months in patients with atopic ec-zema and clinical relevant IgE-mediated sensitisation against birch pollen. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. 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
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E.4 | Principal exclusion criteria |
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 >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)
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E.5 End points |
E.5.1 | Primary end point(s) |
Type and frequency of Adverse Events. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 13 |
E.8.9.1 | In the Member State concerned days | |