Clinical study conducted in several centers to investigate the safety of an accelerated dose escalation of immune therapy with an allergoid drug in patients with birch pollen allergy with or without controlled asthma

Open label phase II multicenter clinical trial to evaluate safety during accelerated dose escalation of an allergoid birch pollen preparation in patients with IgE mediated allergic rhinitis or rhinoconjunctivitis with or without controlled bronchial asthma - ASTOR

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005400-28-DE

Enrollment

120

Registered

2016-05-18

Start date

2016-06-20

Completion date

Unknown

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with seasonal rhinitis or rhinoconjunctivitis with or without controlled asthma during the birch pollen season MedDRA version: 20.1 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis System Organ Class: 100000004870 MedDRA version: 20.0 Level: LLT Classification code 10001726 Term: Allergic rhinitis due to pollen System Organ Class: 100000004870 MedDRA version: 20.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 10

Interventions

Trade Name: Allergovit® Birch Product Name: Allergovit® Birch Product Code: 547a/91a-b Pharmaceutical Form: Suspension for injection INN or Proposed INN: Allergovit® Birch CAS Number: 8000045-25-2 Oth

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Informed consent given according to local requirements before any trial-related activity. (A trial-related activity is any procedure that would not have been performed during the routine management of the patient.) 2. Legally competent male or female outpatient 3. Age between 18 to 65 years 4. IgE-mediated seasonal allergic rhinitis or rhinoconjunctivitis with or without bronchial asthma caused by birch pollen documented by: 4a) SPT wheal for birch pollen = 3mm in diameter 4b) Histamine wheal = 3mm 4c) NaCl control reaction =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: General criteria: 1. Unable to understand and comply with the requirements of the trial, as judged by the investigator 2. Currently participating in any other trial or participated in any other trial within 30 days before inclusion in this trial 3. Low compliance or inability to understand instructions or trial documents 4. Involvement in the planning and conduct of the trial 5. 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 females with childbearing potential (i.e. females who are not chemically or surgically sterilized or females who are not post-menopausal): 10. Positive pregnancy test or pregnant 11. Use of an unacceptable and unreliable contraceptive method during the trial, as judged by the investigator (Reliable and methods of birth control defined as failure rate less than 1% per year) 12. Wish to breastfeed or breast feeding 13. Wish to become pregnant during the course of the trial Immunotherapy criteria: 14. AIT with birch pollen allergens within the last 5 years 15. Current treatment with any kind of immunotherapy 16. AIT with unknown allergen within the last 5 years Diseases and health status: 17. Clinically relevant chronic rhinoconjunctival or respiratory symptoms related to other reasons than allergy 18. Peak expiratory flow (PEF) < 70% of predicted normal (European Coal and Steel Community) under adequate asthma treatment according to GINA guideline (GINA, 2015) 19. Uncontrolled or partly controlled asthma according to GINA guideline (GINA, 2015) 20. Rhinoconjunctival atopic symptoms for 20 years or longer 21. Severe acute or chronic diseases (e.g. diabetes mellitus type I, malignant neoplasia, chronic renal failure, active tuberculosis), severe inflammatory diseases (liver, kidneys) 22. Autoimmune diseases, immune-defects including immune-suppression, immune-complex-induced immunopathies (e.g. HIV, post-transplant patients, vitiligo, lupus erythematodes [SLE], Grave’s disease, multiple sclerosis) 23. Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse) 24. Recurrent seizures 25. Irreversible secondary alterations of the reactive organ (e.g. emphysema, bronchiectasis) 26. Laboratory value 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) (FDA, 2007) Medications: 27. Use of ß-blockers (locally and systemically) 28. Contraindication for use of adrenalin (e.g. acute or chronic symptomatic coronary heart disease, severe hypertension) 29. Completion or ongoing treatment with anti-IgE-antibody 30. Completion or onging long-term treatment with tranquilizer or other psychoactive drugs

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and tolerability of an accelerated dose escalation scheme with Allergovit birch in patients with seasonal allergic rhinitis or rhinoconjunctivitis caused by birch pollen with or without controlled bronchial asthma (acc. to the Global Initiative for Asthma [GINA] 2015);Secondary Objective: not applicable;Primary end point(s): The aim of the trial is to obtain information about the safety and tolerability of dose escalation with 4 and 7 injections, respectively, of Allergovit birch. To achieve this goal, the following safety variables will be considered: • Number, incidence, type, and intensity of local AEs (local reactions at the injection site > 5 cm or leading to distinct discomfort interfering with the patient’s daily activities), AEs and serious adverse events (SAEs) by MedDRA primary System Organ Class and Preferred Term; • AEs as described above but considered to be related to trial medication by the investigator; • Incidence and intensity of anaphylactic reactions after injections according to the WAO grading system; • Number of patients reaching the maintenance dose without dose adjustment; • Change of laboratory values (hematology, clinical chemistry and urinalysis) measured before and after the treatment phase; • Change of vital signs and lung function measured before, during (after each injection) and after treatment; • Number of local reactions at the injection site = 5 cm; • Assessment of the tolerability by the investigator and the patient using a 5 point Likert scale (Likert, 1932) For efficacy, the change of specific total IgG and specific IgG4 for Betula alba between screening visit (S1) and final visit (FV) will be evaluated.;Timepoint(s) of evaluation of this end point: After data base lock, appoximately March 2017	—

Measure

Time frame

Main Objective: To evaluate the safety and tolerability of an accelerated dose escalation scheme with Allergovit birch in patients with seasonal allergic rhinitis or rhinoconjunctivitis caused by birch pollen with or without controlled bronchial asthma (acc. to the Global Initiative for Asthma [GINA] 2015);Secondary Objective: not applicable;Primary end point(s): The aim of the trial is to obtain information about the safety and tolerability of dose escalation with 4 and 7 injections, respectively, of Allergovit birch. To achieve this goal, the following safety variables will be considered: • Number, incidence, type, and intensity of local AEs (local reactions at the injection site > 5 cm or leading to distinct discomfort interfering with the patient’s daily activities), AEs and serious adverse events (SAEs) by MedDRA primary System Organ Class and Preferred Term; • AEs as described above but considered to be related to trial medication by the investigator; • Incidence and intensity of anaphylactic reactions after injections according to the WAO grading system; • Number of patients reaching the maintenance dose without dose adjustment; • Change of laboratory values (hematology, clinical chemistry and urinalysis) measured before and after the treatment phase; • Change of vital signs and lung function measured before, during (after each injection) and after treatment; • Number of local reactions at the injection site = 5 cm; • Assessment of the tolerability by the investigator and the patient using a 5 point Likert scale (Likert, 1932) For efficacy, the change of specific total IgG and specific IgG4 for Betula alba between screening visit (S1) and final visit (FV) will be evaluated.;Timepoint(s) of evaluation of this end point: After data base lock, appoximately March 2017

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Germany

Contacts

Public ContactDr. Gabriele-Cornelia Fox

Allergopharma GmbH & Co. KG

Gabriele-Cornelia.Fox@allergopharma.com00494072765125

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026