Safety study comparing 2 uptitration schemes with Allergovit® grasses

Open label phase II multicentre clinical trial to evaluate safety during shortened uptitration of an allergoid grass pollen preparation in adult patients with IgE mediated allergic rhinitis / rhinoconjunctivitis with or without controlled bronchial asthma - Allergoid-Grass pollen, shortened uptitration phase II safety study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001914-41-DE

Enrollment

120

Registered

2012-07-03

Start date

2012-10-19

Completion date

Unknown

Last updated

2013-12-16

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

Conditions

ICD classificationcode: J 45.0 and J30.1 Patients with IgE mediated allergic rhinitis / rhinoconjunctivitis with or without controlled bronchial asthma MedDRA version: 14.1 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Allergovit® Grasses Product Name: Allergovit® Grasses Product Code: 553a/91a-b Pharmaceutical Form: Suspension for injection INN or Proposed INN: Allergovit® Grasses Other descriptive n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Has the patient given informed consent according to local requirements before any trial-related activities? (A trial-related activity is any procedure that would not have been performed during the routine management of the patient.) 2. Is the patient a legally competent male or female outpatient? 3. Is the patient aged 18 to 65 year? 4. Does the patient suffer from IgE-mediated seasonal allergic rhinoconjunctivitis with or without asthma caused by grass pollen documented by • 4 a) Skin prick test wheal for grass pollen = 3mm in diameter • 4 b) Histamine wheal = 3mm • 4 c) NaCl control reaction =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: General criteria: 1. Is the patient unable to understand and comply with the requirements of the trial, as judged by the investigator? 2. Is the patient currently participating in any other trial or has the patient participated in any other trial within 30 days before inclusion in this trial? 3. Does the patient show low compliance or inability to understand instructions/trial documents? 4. Is/was the patient involved in the planning and conduct of the trial? 5. Is the patient an employee of Allergopharma Joachim Ganzer KG or of one of the trial sites? 6. Is the patient in any relationship of dependence with the sponsor and/or with the investigator? 7. Has the patient been previously enrolled or randomised to treatment in the present trial? 8. Is the patient mentally disabled? 9. Is the patient institutionalised due to an official or judicial order? For females with childbearing potential (i.e. females who are not chemically or surgically sterilised or females who are not post-menopausal): 10. Does the patient have a positive pregnancy test at screening? 11. Does the patient use an unacceptable and unreliable contraceptive method during the trial, as judged by the investigator? (Reliable and highly effective methods of birth control with a low failure rate (i.e. less than 1% per year) when used consistently and correctly are, e.g., implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partners.) 12. Is the patient pregnant or wishes to breast feed? 13. Is the patient seeking to become pregnant? Immunotherapy criteria: 14. Has the patient undergone previous specific immunotherapy with grass pollen allergens in any formulation? 15. Is the patient currently undergoing any sort of immunotherapy? Other allergies: 16. Has the patient an (anamnestically confirmed) clinically relevant sensitisation to a) Dermatophagoides farinae b) Dermatophagoides pteronyssinus c) birch pollen, d) alder pollen, e) hazel pollen and is any of the Skin Prick Test results greater than the result for grass pollen? 17. Has the patient an (anamnestically confirmed) clinically relevant sensitisation to a) cat epithelia b) dog epithelia c) Dermatophagoides farinae d) Dermatophagoides pteronyssinus e) birch pollen, f) alder pollen, g) hazel pollen and is any of the spec. IgE results greater than the result for grass pollen? Diseases and health status: 18. Has the patient a PEF or FEV1 < 80% of predicted normal (ECSC)? 19. Does the patient suffer from perennial asthma? 20. Has the patient uncontrolled or partly controlled asthma according to GINA guidelines (GINA, 2006)? 21. Does the patient suffer from rhinoconjunctival atopy symptoms for 20 years or longer? 22. Does the patient suffer from severe acute or chronic diseases (e.g. Diabetes mellitus type I, malignant neoplasia, chronic renal failure, active Tuberculosis), severe inflammatory diseases (liver, kidneys)? 23. Does the patient suffer from autoimmune diseases, immune-defects including immune-suppression, immune-complex-induced immunopathies (e.g. HIV, post-transplant patients, lupus erythematodes [SLE], Grave’s disease, Hashimoto’s thyroiditis, Multiple Sclerosis)? 24. Does the patient suffer from severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)? 25. Does the patient suffer from recurrent seizures? 26. Has the patient any laboratory value

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to obtain information about the safety and tolerability of uptitration with 4 injection (shortened uptitration - Group I) and 7 injections (standard uptitration - Group II), respectively, of Allergovit® grasses. ;Secondary Objective: Exploratory immunological parameters will be evaluated at the centre of the co-ordinating investigator. The aim is to evaluate assays within the context of a controlled immunotherapy trial to obtain measures of variability and reliability in order to make these parameters potentially available for future trials as additional endpoints.;Primary end point(s): As this study is a safety study, no efficacy endpoints will be evaluated. The aim of the study is to obtain information about the safety and tolerability of uptitration with 4 and 7 injections, respectively, of Allergovit® grasses. To achieve this goal, the following safety variables will be considered: • the numbers, incidence, type and intensity of local adverse events, adverse events and serious adverse events by MedDRA primary SOC and Preferred Term, • adverse events as described above but considered to be related to trial medication by the investigator, • the incidence and intensity of systemic anaphylactic reactions after injections according to the WAO grading system, • the change of laboratory values (hematology, clinical chemistry and urinalysis) measured before and after the treatment phase, • the change of vital signs and lung function measured before, during and after treatment, • number and size of local reactions at the injection site < 5 cm, and • an assessment of the overall tolerability by the investigator and the patient using a 5 point Likert scale (Likert, 1932) ;Timepoint(s) of evaluation of this end point: uptitration period will be evaluated at study end.	—

Measure

Time frame

Main Objective: The aim of the study is to obtain information about the safety and tolerability of uptitration with 4 injection (shortened uptitration - Group I) and 7 injections (standard uptitration - Group II), respectively, of Allergovit® grasses. ;Secondary Objective: Exploratory immunological parameters will be evaluated at the centre of the co-ordinating investigator. The aim is to evaluate assays within the context of a controlled immunotherapy trial to obtain measures of variability and reliability in order to make these parameters potentially available for future trials as additional endpoints.;Primary end point(s): As this study is a safety study, no efficacy endpoints will be evaluated. The aim of the study is to obtain information about the safety and tolerability of uptitration with 4 and 7 injections, respectively, of Allergovit® grasses. To achieve this goal, the following safety variables will be considered: • the numbers, incidence, type and intensity of local adverse events, adverse events and serious adverse events by MedDRA primary SOC and Preferred Term, • adverse events as described above but considered to be related to trial medication by the investigator, • the incidence and intensity of systemic anaphylactic reactions after injections according to the WAO grading system, • the change of laboratory values (hematology, clinical chemistry and urinalysis) measured before and after the treatment phase, • the change of vital signs and lung function measured before, during and after treatment, • number and size of local reactions at the injection site < 5 cm, and • an assessment of the overall tolerability by the investigator and the patient using a 5 point Likert scale (Likert, 1932) ;Timepoint(s) of evaluation of this end point: uptitration period will be evaluated at study end.

—

Secondary

Measure	Time frame
Secondary end point(s): Exploratory immunological parameters will be evaluated at the centre of the co-ordinating investigator (see section 2.2). The aim is to evaluate assays within the context of a controlled immunotherapy trial to obtain measures of variability and reliability in order to make these parameters potentially available for future trials as additional endpoints. • The kinetics, magnitude and onset T-cell activation markers (CD69+ and CD103+) will be assessed by flow cytometry • T-cell derived cytokine production will be determined by IL-4 and IFN-gamma ELISPOT at start and maintenance of SCIT • Mucosal RNA-content in swabs will be determined • Mucosal frequency of T-cells (CD3+) during the course of SCIT will be determined using flow cytometry ;Timepoint(s) of evaluation of this end point: o at visit T1/1 (after randomisation but prior to first injection) o prior to injection with maximum dose normally administered at visit T1/4 group I or visit T1/7 group II, respectively o 6h after injection with maximum dose normally administered at visit T1/4 group I or visit T1/7 group II, respectively o before the last treatment injection (normally at visit T1/9) o 6h after the last treatment injection (normally at visit T1/9)	—

Measure

Time frame

Secondary end point(s): Exploratory immunological parameters will be evaluated at the centre of the co-ordinating investigator (see section 2.2). The aim is to evaluate assays within the context of a controlled immunotherapy trial to obtain measures of variability and reliability in order to make these parameters potentially available for future trials as additional endpoints. • The kinetics, magnitude and onset T-cell activation markers (CD69+ and CD103+) will be assessed by flow cytometry • T-cell derived cytokine production will be determined by IL-4 and IFN-gamma ELISPOT at start and maintenance of SCIT • Mucosal RNA-content in swabs will be determined • Mucosal frequency of T-cells (CD3+) during the course of SCIT will be determined using flow cytometry ;Timepoint(s) of evaluation of this end point: o at visit T1/1 (after randomisation but prior to first injection) o prior to injection with maximum dose normally administered at visit T1/4 group I or visit T1/7 group II, respectively o 6h after injection with maximum dose normally administered at visit T1/4 group I or visit T1/7 group II, respectively o before the last treatment injection (normally at visit T1/9) o 6h after the last treatment injection (normally at visit T1/9)

—

Countries

Germany

Contacts

Public ContactClinical Trials Department

Allergopharma Joachim Ganzer KG

dietrich.haefner@allergopharma.de004904072765340

Outcome results

None listed

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