E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adult patients with perennial allergic rhinoconjunctivitis |
|
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 |
|
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 II trial is the proof of concept for CYT003-QbG10 (QbG10) as monotherapy in patients with perennial allergic rhinoconjunctivitis due to house dust mite and/or cat allergy. An active treatment arm will be compared to a placebo arm using conjunctival allergen challenge as efficacy readout parameter. |
|
E.2.2 | Secondary objectives of the trial |
Furthermore, safety and tolerability of the treatment will be assessed |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•18 to 65 years of age • Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite and/or cat allergens as evident from: - history of ≥ 2 years, and - positive skin prick test to house dust mite and/or cat allergen extract and - (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 ; if allergic to both house dust mites and cat, CPT should be performed with the allergen extract that caused the bigger wheal in the screening SPT • Patient did not perform an environmental intervention such as house dust mite remediation and/or cat removal to physically avoid the allergens he/she is allergic to 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, 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 • Patient gave written informed consent • Patient is willing and able to comply with all trial requirements.
|
|
E.4 | Principal exclusion criteria |
• Clinically relevant seasonal allergy/-ies which is/are expected to interfere with the patient’s study treatment schedule and/or assessments as judged by the investigator • Clinically relevant perennial allergy/-ies other than house dust mites or cat allergy • 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 • History of anaphylaxis • Contraindication for adrenaline/epinephrine as allergic shock rescue medication • Current diagnosis of asthma that requires permanent treatment with corticosteroids, or severe asthma according to guidelines • 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 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 or lactation • Female planning to become pregnant during the study period • History of or present abuse of alcohol or other recreational drugs as judged by the investigator • 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
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy
Allergen challenge parameters: • Conjunctival provocation test (CPT) scores using a HDM-/cat-specific allergen dilution series. • Skin Prick Test (SPT) results using a HDM-/cat-specific allergen. Immunologic pharmacodynamic parameters: • anti-HDM/-cat IgG (total and subtypes IgG1, IgG2, IgG3 and IgG4). • anti-HDM/-cat IgE. • IgE (total). • Anti-Qb antibodies. Clinical parameters: • Disease scores and rescue medication use will be recorded by the patients in allergy diaries. • Quality of life (QoL) scores will be recorded in the CRF.
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 and physical examination are performed at screening and at study end. • Routine laboratory tests (hematology, blood chemistry, urinalysis) and test for CRP are performed at screening and at study end and during follow-up. • Antinuclear antibodies (ANA) tests are performed at visit 1 and at study end and during follow-up. • Injection sites will be inspected at each injection day, at the study end and at the follow-up visit 9 by the investigator; furthermore, the patients record local reactions at the injection site in a diary during the week following each injection.
|
|
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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 15 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 15 |