Adult patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy MedDRA version: 9.1 Level: LLT Classification code 10063527 Term: Allergic respiratory symptom
Conditions
Interventions
Product Name: CYT005-AllQbG10 (Combination of CYT003-QbG10 + House Dust Mite Allergen)
Pharmaceutical Form: Suspension for injection
Current Sponsor code: CYT003-QbG10
Concentration unit: µg microgra
50% D. pteronyssinus)
Concentration unit: SQU Standardised Quality Unit(s) (Deprecated)
Concentration type: up to
Concentration number: 5000-
Pharmaceutical form of the placebo: Suspension for injecti
Sponsors
Cytos Biotechnology AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 to 65 years of age 2. Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite allergens (Dermatophagoides pteronyssinus and/or D. farinae) as evident from: - history of =2 years, and - positive skin prick test (SPT, mean wheal diameter =3mm larger than negative control) to house dust mite allergen solution (50:50 mixture of D. pteronyssinus and D. farinae SPT solutions) (for SPT instruction refer to Appendix 11.1) and - total conjunctival provocation test (CPT) score =8 at 5,000 (S)BE/mL and =2 at 500 (S)BE/mL of the ten-fold dilution series of house dust mite allergen solution (for CPT instruction refer to Appendix 11.2) 3. Patient did not perform a house dust mite sanitation to physically avoid house dust mite allergens within 2 months prior to his/her screening visit and patient does not plan to perform such an environmental intervention during study participation 4. Female participants must meet one of the following criteria: - No reproductive potential due to menopause (one year without menses, in case of doubts serum FSH will be determined and must be >30 U/mL), hysterectomy, bilateral oophorectomy, or tubal ligation - Patient agrees to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 1 additional month after the last immunization (hormone-based, or intrauterine device, or double barrier contraception, i.e. condom + diaphragm, condom or diaphragm + spermicidal gel or foam) 5. Patient gave written informed consent 6. Patient is willing and able to comply with all trial requirements (such as diary completion, sticking to the study’s visit schedule and also the study rules regarding use of anti-allergic and other concomitant medication) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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
Exclusion criteria: 1. Clinically relevant seasonal allergy/-ies (especially against tree pollen) which is/are expected to interfere with the patient’s study treatment schedule and/or assessments (e.g. via usage of anti-allergic drugs or presence of allergy symptoms) as judged by the investigator (the patient should not report clinically relevant seasonal allergy symptoms between January and May) 2. Clinically relevant perennial allergy/-ies other than house dust mites allergy (e.g. cat, moulds) 3. Contraindication for Conjunctival Provocation Test and/or Skin Prick Test (refer to Appendices 11.1 and 11.2) 4. Use of any concomitant medication that could affect the patient’s study treatment response and/or allergic sensitivity or assessment results during the trial or that represents a contraindication for any study assessment as judged by the investigator (for a list of relevant drugs and appropriate wash-out times refer to Appendix 11.3; see also the “concomitant medication” section of this protocol) 5. Any contraindication to Novo-Helisen® Depot, in particular use of contraindicated drugs such as betablockers, ACE/ATII inhibitors (refer to Appendix 11.4) 6. Any other specific immunotherapy (SIT) planned during the whole study period or any former specific immunotherapy (SIT) within the last five years (independent of allergens administered and treatment outcome) 7. History of anaphylaxis 8. Contraindication for adrenaline/epinephrine as allergic shock rescue medication (e.g. acute or chronic symptomatic coronary heart disease, severe arterial hypertension) 9. Actual significant obstructive pulmonary disorder (FEV1< 70% of predicted value) 10. Asthma, with the exception of intermittent asthma according to the asthma severity definitions of the Global Initiative for Asthma (GINA 2006) (refer to Appendix 11.5) 11. Any vaccination planned during study treatment period 12. Presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological and psychiatric disease as judged by the investigator 13. Completed or ongoing treatment with tranquilizers or other psychoactive drugs for treatment of a psychiatric disease/condition 14. Presence of active infectious disease as judged by the investigator 15. History of recurrent invasive streptococcal or staphylococcal infections, or known interleukin-1 receptor-associated kinase 4 (IRAK 4) deficiency. 16. Confirmed or suspected current infection with HIV, HBV, or HCV (e.g. based on positive serum test) 17. Current diagnosis or history of malignancy; presence of suspicious lymphadenopathy or splenomegaly on physical examination 18. Pregnancy (based on positive serum test at screening visit) or lactation 19. Female planning to become pregnant during the study period 20. History of abuse of alcohol or other recreational drugs 21. Use of an investigational drug within 30 days before enrolment, or planned use during the whole study period 22. Previous participation in a clinical trial with a Qb-based vaccine (DerQb, NicQb, GhrQb, AngQb, TNFQb, QbG10, and AllQbG10) 23. Possible dependency of the patient on sponsor and/or investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this clinical Phase II trial is the investigation of the safety, tolerability, immunogenicity and clinical efficacy of the combination treatment AllQbG10 in a double-blind setting employing the treatment regimen that has been shown to be highly efficient in the open label proof-of-concept study CYT005-AllQbG10 01 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy.;Secondary Objective: ;Primary end point(s): Efficacy • Allergen challenge parameters - Conjunctival provocation test (CPT) scores using a HDM-specific allergen dilution series - Skin Prick Test (SPT) results using a HDM-specific allergen solution • Immunogenicity and immunologic pharmacodynamic parameters - anti-HDM IgG (total and subclasses – IgG total and subclass IgG4 analyses will be performed by the central laboratory; additional, exploratory anti-HDM antibody analyses (e.g. other IgG subclasses) will be performed by Cytos) - anti-HDM IgE - IgE (total) - Anti-Qb IgG (total IgG as a measure of drug exposure) • Clinical parameters - Disease symptom scores and relief medication use will be recorded by the patients in allergy diaries - Quality of life (QoL) scores will be recorded in the CRF All efficacy parameters will be assessed for changes over time from baseline to post treatment (i.e. from screening visit as baseline to the core study completion visit and the follow-up visits) both within subjects and between groups. Additional immunologic analyses in available serum samples might be performed triggered by scientifically relevant findings from the exploratory analysis. Safety and tolerability • Adverse events and concomitant medications are recorded throughout the study • Vital signs (blood pressure, heart rate, body temperature), are recorded at each visit • ECG, routine laboratory tests (hematology, blood chemistry, urinalysis) and the test for CRP are performed at the screening visit, at the core study completion visit and at | — |
Countries
Germany
Outcome results
None listed