moderate to severe allergic rhinitis or rhinoconjunctivitis with or without asthma MedDRA version: 21.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 100000004855 MedDRA version: 20.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853
Conditions
Interventions
Product Name: Novo-Helisen Depot house dust mites
Pharmaceutical Form: Suspension for injection
CAS Number: 8000045-20-7
Other descriptive name: ALLERGENS, HOUSE DUST & MITE
Concentration unit: U/ml u
Sponsors
Allergopharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent given from patient (and parents/legal guardian(s), as applicable) 2. Age between 12 and = 65 years 3. IgE-mediated moderate to severe allergic rhinitis or rhinoconjunctivitis with or without allergic asthma caused by house dust mite allergens (established and documented as part of the screening procedures) 4. Symptoms of allergic rhinitis or rhinoconjunctivitis triggered by house dust mite exposure over at least the last 2 years 5. No diagnosis of bronchial asthma in medical history, or confirmed diagnosis of asthma as being “well controlled” 6. Previous symptomatic anti-allergic treatment for at least 2 years prior to enrolment 7. Negative SARS-CoV-2 test result Are the trial subjects under 18? yes Number of subjects for this age range: 70 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 69 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: General criteria: 1. Patients and if relevant 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 another clinical trial or participating in any other clinical trial within 30 days prior informed consent for this trial 3. Low adherence to trial procedures expected 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. Patients and if relevant parent/legal guardian is employee of Allergopharma GmbH & Co. KG or of one of the trial sites or CRO 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 urine pregnancy test or pregnant 11. Wish to become pregnant during the course of the trial 12.Not using highly effective and reliable contraception, as judged by the investigator (reliable and highly effective methods of birth control defined as failure rate less than 1% per year) 13. Wish to breast feed or breast feeding Immunotherapy criteria: 14. History of a confirmed anaphylaxis after an AIT injection 15. AIT with house dust mite allergoids or allergens within the last 5 years 16. Current treatment with any kind of allergen immunotherapy (AIT) 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 recommendation (GINA 2020) 20. Uncontrolled or partly controlled asthma according to GINA recommendation (INA 2020) 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. COVID-19, chronic urticaria, mastocytose, active tuberculosis, diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys), acute viral and bacterial infections presenting with fever 23. Autoimmune diseases, immune defects including immunosuppression, immune-complexinduced 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 ß-blockers (locally or systemically), ACE inhibitors 29. Contraindication for use of adrenalin (e.g. acute or chronic symptomatic coronary heartdisease, severe hypertension) 30. Completion or ongoing treatment with anti-IgE-a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the safety and tolerability of an accelerated high dose escalation scheme with one strength for allergen immunotherapy with NHD D.p./D.f. 50%/50% compared to the standard escalation scheme involving 3 strengths in adults and adolescents with rhinitis or rhinoconjunctivitis caused by house dust mite allergens with or without allergic asthma;Secondary Objective: Not applicable;Primary end point(s): (descriptive safety variables) 1) Number, incidence, time of onset, type and intensity of AEs and serious adverse events (SAE) according to MedDRA primary system organ class (SOC) and preferred term 2) Number, incidence, time of onset, type and intensity of AEs and serious adverse events assessed as drug related (by investigator) according to MedDRA primary SOC and preferred term 3) Incidence and intensity of allergic systemic reactions after injections according to the World Allergy Organization (WAO) grading system 4) Number of patients reaching the maintenance dose without dose adjustment due to adverse events 5) Change of laboratory values (hematology, clinical chemistry and urinalysis) measured before and after the treatment phase 6) Change of vital signs and lung function measured before and after the treatment phase 7) 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: endpoints 1, 2, 3: cumulative data from every visit except screening visit 1: for accelerated dose escalation group (G1): screening phone contact (week -2 - 0), weeks 0, 1, 2, 3, 4, 5, 7, 11, follow-up visit (week 13 - 15) for standard dose escalation group (G2): screening phone contact (week -2 - 0), weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 8, 10, 11, 12, 13, 15, 19, follow-up visit (week 21 - 23) endpoint 4: for G1: week 5 for G2: 13 endpoints 5, 6: screening visit 1, follow-up visit (G1: week 13 - 15; G2: week 21 - 23) endpoint 7: for G1: weeks 1, 2, 3, 4, 5, 7, 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): exploratory enpoint: IgG4 specific for Dermatophagoides farinae and Dermatophagoides pteronyssinus;Timepoint(s) of evaluation of this end point: Screening visit (week -14 - 0), follow-up visit (group 1: week 13 - 15; group 2: week 21 - 23) | — |
Countries
Germany, Poland
Contacts
Public ContactClinical Project Leader
Allergopharma GmbH & Co. KG
Outcome results
None listed