A clinical study conducted in several test centers to investigate the safetyof an accelerated high dose escalation schedule for an immune therapy in pediatric patients with hayfever with or without asthma.

Phase 1

• Conditions: Patients with moderate to severe seasonal rhinitis or rhinoconjunctivitiswith or without asthma; MedDRA version: 20.1Level: LLTClassification code 10039776Term: Seasonal allergic rhinitisSystem Organ Class: 100000004870; MedDRA version: 20.0Level: LLTClassification code 10001726Term: Allergic rhinitis due to pollenSystem Organ Class: 100000004870; MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853; MedDRA version: 21.1Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 100000004855; MedDRA version: 21.1Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-000548-25-DE
• Lead Sponsor: Allergopharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-27
• Study Completion: 2019-06-25
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

1. Written informed consent given from patient and parents/legal guardian(s) according to local requirements before any trial-related activities started (a trial-related activity is any procedure that would not have been performed during the routine management of the patient)
2. Age between 5 to < 18 years
3. IgE-mediated seasonal moderate to severe allergic rhinitis or rhinoconjunctivitis with or without allergic asthma caused by grass pollen documented by:
• Skin prick test (SPT):
• wheal for grass pollen = 3 mm in diameter
• Histamine wheal = 3 mm (positive control)
• NaCl reaction < 2 mm (negative control)
• Assessment of moderate to severe rhinitis according to ARIA guideline (Brozek et al. 2010)
• Immunoassay result for specific IgE = 0.70 kU/L to grass pollen
4. At least 1 month symptoms of allergic rhinitis or rhinoconjunctivitis in May to August triggered by grass pollen exposure over the last two seasons.
5. In case of bronchial asthma at entry: confirmed diagnosis of asthma according to GINA guideline (GINA 2017)
6. In case of a diagnosed asthma: asthma symptoms classified as being well controlled” according to GINA guideline (GINA 2017)
7. Previous treatment with anti-allergic treatment for at least 2 seasons prior to enrolment

Are the trial subjects under 18? yes
Number of subjects for this age range: 140
F.1.2 Adults (18-64 years) no
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

General criteria:
1. Adolescent and/or parents/legal guardian(s) are unable to understand and comply with the requirements of the trial, as judged by the investigator
2. Currently participating in any other clinical trial or participating in any other clinical trial within 30 days prior informed consent for this trial
3. Low compliance or inability to understand instructions/trial documents by participant and/or parents/legal guardian(s)
4. Involvement in the planning and conduct of the trial
5. Adolescent and/or parent/legal guardian is employee of Allergopharma GmbH & Co. KG or of one of the trial sites
6. Any relationship of dependence with the sponsor or with the investigator
7. Previous randomization to treatment in the present trial
8. Mentally disabled
9. Institutionalized due to an official or judicial order
For female patients with childbearing potential
10. Positive pregnancy test or pregnant
11. Use of an unacceptable or unreliable contraceptive method during the trial, as judged by the investigator (reliable and highly effective methods of birth control defined as failure rate less than 1% per year)
12. Wish to breast feed or breast feeding
13. Wish to become pregnant during the course of the trial
Immunotherapy criteria:
14. History of a confirmed anaphylaxis after an AIT injection
15. AIT with grass pollen within the last 5 years
16. Current treatment with any kind of immunotherapy
17. AIT with unknown allergen within the last 5 years
Diseases and health status:
18. Clinically relevant chronic rhinoconjunctival or respiratory symptoms related to other reasons than allergy
19. Forced expiratory volume in 1 second (FEV1) < 70 % of predicted normal values according to Quanjer (Quanjer et al. 2012) under adequate asthma treatment according to GINA guidelines (GINA 2017)
20. Uncontrolled or partly controlled asthma according to GINA guidelines (GINA 2017)
21. Acute asthma attack within the last 6 months prior to randomization defined as unscheduled doctors visit, hospitalization, or emergency visit
22. Severe acute or chronic diseases (e.g. chronic urticaria, mastocytose, active tuberculosis, diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys)
23. Autoimmune diseases, immune defects including immunosuppression, immune-complex-induced immunopathies (e.g. HIV, post-transplant patients, lupus erythematodes [SLE], vitiligo, Grave’s disease, multiple sclerosis)
24. Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)
25. Recurrent seizures (e.g. febrile convulsion, untreated epilepsy)
26. Irreversible secondary alterations of the reactive organ (e.g. emphysema, bronchiectasis)
27. For assessment the normal reference ranges of the central laboratory should be applied. If out of range, laboratory values greater than grade 1 according to the FDA Guidance for Industry (Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials)will lead to exclusion of the patient.
Medications:
28. Use of beta-blockers (locally or systemically), ACE inhibitors
29. Contraindication for use of adrenalin (e.g. acute or chronic symptomatic coronary heart disease, severe hypertension)
30. Completion or ongoing treatment with anti-IgE-antibody
31. Completion or ongoing long-term treatment with tranquilizer or other psychoactive dru

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified