A clinical study conducted in several test centres to investigate the safety and tolerability of a year-round dosage of immune therapy with an Allergoid drug in patients with hay fever and or without controlled asthma.

A multicenter, randomized, open-label clinical trial to evaluate safety and tolerability of a year-round initiation of specific immunotherapy with an aluminum hydroxide adsorbed allergoid preparation of 6-grasses in patients with moderate to severe seasonal rhinitis or rhinoconjunctivitis with or without controlled asthma. - SuBITo

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002409-13-DE

Enrollment

240

Registered

2015-08-28

Start date

2015-11-19

Completion date

Unknown

Last updated

2017-10-30

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

Conditions

Patients with moderate to severe seasonal rhinitis or rhinoconjunctivitis with or without controlled asthma. MedDRA version: 19.0 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis System Organ Class: 100000004870 MedDRA version: 19.0 Level: LLT Classification code 10001726 Term: Allergic rhinitis due to pollen System Organ Class: 100000004870 MedDRA version: 19.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853

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 CAS Number: 8000045-2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent given 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. Legally competent male or female outpatient 3. Age = 18 and = 65 years 4. IgE-mediated seasonal allergic rhinitis or rhinoconjunctivitis with or without controlled allergic asthma caused by grass pollen as confirmed by the following test procedures: • Skin prick test (SPT): • wheal for 6-grasses pollens = 3 mm in diameter • Histamine wheal = 3 mm (positive control) • NaCl 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 participating in any other trial within 30 days before inclusion into this trial 3. Low compliance or inability to understand instructions/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 or any relationship with the sponsor or investigator 6. Mentally disabled 7. 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 postmenopausal): 8. Positive pregnancy test at screening or during the course of the trial 9. 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) 10. Wish to breastfeed 11. Wish to become pregnant during the course of the trial Immunotherapy criteria: 12. AIT with grass pollen within the last 5 years 13. Currently under any sort of immunotherapy 14. AIT with unknown allergen within the last 5 years Diseases and health status: 15. Clinically relevant chronic rhinoconjunctival or respiratory symptoms related to other reasons than allergy 16. Peak expiratory flow (PEF) < 70% of predicted normal (ECSC) under adequate asthma treatment according to GINA 2015 17. Uncontrolled or partly controlled asthma according to GINA 2015 18. Perennial and continuously treated asthma 19. Rhinoconjunctival atopic symptoms for 20 years or longer 20. Severe acute or chronic diseases (e.g. active tuberculosis, diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys) 21. Autoimmune diseases, immune defects including immunosuppression, immune-complex-induced immunopathies (e.g. HIV, post-transplant patients, lupus erythematodes [SLE], vitiligo, Grave’s disease) 22. Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse) 23. Recurrent seizures 24. Irreversible secondary alterations of the reactive organ (e.g. emphysema, bronchiectasis) 25. 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) Medications: 26. Use of beta-blockers (locally or systemically) 27. Contraindication for use of adrenaline (e.g. acute or chronic symptomatic coronary heart disease, severe hypertension) 28. Completion or ongoing treatment with anti-IgE-antibody 29. Completion or ongoing long-term treatment with tranquilizer or other psychoactive drugs 30. Use of prophylactic or continuous treatment with anti-allergic medication in fixed (constant) dose during the pollen season

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this therapeutic phase IIIb trial is to evaluate the safety and tolerability of a year-round initiation start of immunotherapy with Allergovit® 6-grasses in patients with rhinitis or rhinoconjunctivitis, caused by grasses, with or without controlled allergic asthma compared to a standard therapy. A possible influence (masking of adverse events) of a symptomatic co-medication during intraseasonal therapy will be considered.;Secondary Objective: Not applicable.;Primary end point(s): The aim of the trial is to obtain information about the safety and tolerability of an intraseasonal compared to a standard dose escalation of Allergovit® 6-grasses. To achieve this goal, the following safety variables will be assessed: • the incidence, type and intensity of AEs and serious adverse events (SAE) according to MedDRA primary system organ class (SOC) and preferred term, • the incidence, type and intensitiy of AEs assessed as drug related (by investigator) according to MedDRA primary system organ class (SOC) and preferred term, • the incidence, type and intensity of local AEs assessed as drug related (by investigator) according to MedDRA primary system organ class (SOC) and preferred term, • the incidence and intensity of anaphylactic reactions after injections according to the World Allergy Organization (WAO) grading system, • the use of anti-symptomatic co-therapy • the change of laboratory values (hematology, clinical chemistry and urinalysis) measured before and after the treatment phase, • the change of vital signs, • the change of PEF from patients, measured before, during and after treatment, • an assessment of the overall tolerability by the investigator and the patient using a 5 point Likert scale. Exploratory immunological parameters will be evaluated at Screening (S1) and Final Visit (FV): • Specific IgG4 for Phleum pratense. ;Timepoint(s) of evaluation of this end point: After database lock, approximatly April 2017.	—

Measure

Time frame

Main Objective: The main objective of this therapeutic phase IIIb trial is to evaluate the safety and tolerability of a year-round initiation start of immunotherapy with Allergovit® 6-grasses in patients with rhinitis or rhinoconjunctivitis, caused by grasses, with or without controlled allergic asthma compared to a standard therapy. A possible influence (masking of adverse events) of a symptomatic co-medication during intraseasonal therapy will be considered.;Secondary Objective: Not applicable.;Primary end point(s): The aim of the trial is to obtain information about the safety and tolerability of an intraseasonal compared to a standard dose escalation of Allergovit® 6-grasses. To achieve this goal, the following safety variables will be assessed: • the incidence, type and intensity of AEs and serious adverse events (SAE) according to MedDRA primary system organ class (SOC) and preferred term, • the incidence, type and intensitiy of AEs assessed as drug related (by investigator) according to MedDRA primary system organ class (SOC) and preferred term, • the incidence, type and intensity of local AEs assessed as drug related (by investigator) according to MedDRA primary system organ class (SOC) and preferred term, • the incidence and intensity of anaphylactic reactions after injections according to the World Allergy Organization (WAO) grading system, • the use of anti-symptomatic co-therapy • the change of laboratory values (hematology, clinical chemistry and urinalysis) measured before and after the treatment phase, • the change of vital signs, • the change of PEF from patients, measured before, during and after treatment, • an assessment of the overall tolerability by the investigator and the patient using a 5 point Likert scale. Exploratory immunological parameters will be evaluated at Screening (S1) and Final Visit (FV): • Specific IgG4 for Phleum pratense. ;Timepoint(s) of evaluation of this end point: After database lock, approximatly April 2017.

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Secondary

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

Countries

Germany

Contacts

Public ContactPD Dr. med Dietrich Häfner

Allergopharma GmbH & Co. KG

dietrich.haefner@allergopharma.com00494072765316

Outcome results

None listed

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