E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adult patients with perennial allergic rhinoconjunctivitis due to house dust mite |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039097 |
E.1.2 | Term | Rhinoconjunctivitis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this clinical Phase IIb trial is to define the dose of QbG10 for further development by investigating clinical efficacy, safety, tolerability and immunogenicity of two doses versus placebo. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 18 to 65 years of age - Perennial allergic rhinoconjunctivitis due to clinically relevant allergy towards house dust mite allergens (Dermatophagoides pteronyssinus and/or D. farinae) as evident from: - history of ≥2 years, and - positive skin prick test (SPT) with a mean wheal diameter ≥3mm larger than negative control to house dust mite allergen solution (50:50 mixture of D. pteronyssinus and D. farinae) and - positive conjunctival provocation test (CPT) with a score ≥2 at 1 HEP/mL and a score ≥8 at 10 HEP/mL concentrations of a dilution series of house dust mite allergen (50:50 mixture of D. pteronyssinus and D. farinae). - 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
-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) - Patient gave written informed consent - Patient is willing and able to comply with all trial requirements (such as diary completion, sticking to the study’s visit schedule and also to the study rules regarding use of anti-allergic and other concomitant medication)
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E.4 | Principal exclusion criteria |
- Clinically manifested seasonal allergy/-ies 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 suffer from clinically relevant seasonal allergy symptoms between January and May) - Clinically relevant perennial allergy/-ies other than house dust mites allergy (e.g. cat, moulds) - Contraindication for Conjunctival Provocation Test and/or Skin Prick Test - 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. - Any other specific immunotherapy (SIT) planned during the whole study period or any former specific immunotherapy (SIT) within the last five years with house dust mite allergens (Dermatophagoides pteronyssinus and/or D. farinae) - History of anaphylaxis - Contraindication for adrenaline/epinephrine as allergic shock rescue medication (e.g. acute or chronic symptomatic coronary heart disease, severe arterial hypertension) - Actual significant obstructive pulmonary disorder as judged by the investigator - Current diagnosis of asthma that requires treatment with oral or daily inhaled corticosteroids; intermittent and mild persistent asthma according to the asthma severity definitions of the Global Initiative for Asthma (GINA 2006) are permitted. - Any vaccination planned during study treatment period - Presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological and psychiatric disease as judged by the investigator - Completed or ongoing treatment with tranquilizers or other psychoactive drugs for treatment of a psychiatric disease/condition - Presence of active infectious disease as judged by the investigator - History of recurrent invasive streptococcal or staphylococcal infections, or known interleukin-1 receptor-associated kinase 4 (IRAK 4) deficiency - Confirmed or suspected current infection with HIV, HBV or HCV - Current diagnosis or history of malignancy; presence of suspicious lymphadenopathy or splenomegaly on physical examination - Pregnancy (based on positive urine test at screening visit) or lactation - Female planning to become pregnant during the study period - History of abuse of alcohol or other recreational drugs - Use of an investigational drug within 30 days before enrolment, or planned use during the whole study period - Previous participation in a clinical trial with a Qb-based vaccine - Possible dependency of the patient on sponsor and/or investigator
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E.5 End points |
E.5.1 | Primary end point(s) |
Rhinoconjunctivitis symptom and medication scores: ocular and nasal allergy symptoms and relief medication use are recorded by the patients in a allergy diary over 2 weeks
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 42 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |