Adult patients with perennial allergic rhinoconjunctivitis MedDRA version: 9.1 Level: LLT Classification code 10039097 Term: Rhinoconjunctivitis
Conditions
Interventions
Product Name: CYT003-QbG10
Pharmaceutical Form: Solution for injection
Current Sponsor code: QbG10
Concentration unit: µg microgram(s)
Concentration type: range
Concentration number: 300-900
Pharmaceu
Sponsors
Cytos Biotechnology AG
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Furthermore, safety and tolerability of the treatment will be assessed;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. | — |
Countries
Estonia, Latvia, Lithuania
Outcome results
None listed