A dose-ranging clinical study to determine the range of grass pollen allergen (gpCPT+) concentrations to be used in a conjunctival provocation test to grade moderate to severe hay fever in patients suffering from allergic inflammation of the conjunctiva which is caused by grass pollen allergens.
- Conditions
- This clinical trial aims to evaluate a conjunctival provocation test (CPT) with the IMP gpCPT+ for the assessment and grading of grass pollen allergic rhinoconjunctivitis. Thus, a diagnostic solution will be tested and not medical condition or disease. Patients will be included in this trial who are suffering from grass pollen allergic rhinoconjunctivitis.MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2017-004616-19-DE
- Lead Sponsor
- ASIT biotech S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 76
For all subjects and patients:
•Signed and dated Informed Consent Form by a legally competent patient
•Female or male subjects aged 18–64 years
•Being in good physical and mental health
•For females: non-pregnant, non-lactating with adequate contraception as defined in the trial protocol in section 3.4.2 or females unable to bear children (i.e. tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period))
For non-allergic healthy subjects only (not for ARC patients):
•Having no grass pollen induced allergy based on the following criteria:
oNo medical history of moderate to severe persistent allergic rhinoconjunctivitis (ARC) for the grass pollen season
oA negative skin prick test (SPT - wheal diameter < 3 mm) to grass pollen mixture, histamine wheal = 3 mm, NaCl control reaction < 2 mm
oSpecific IgE against grass pollen mixture < 0.7 kU/L
For ARC patients only (not for non-allergic, healthy subjects):
•Having the diagnosis of grass pollen induced allergy based on all the following criteria:
-A medical history of moderate to severe persistent seasonal ARC for the grass pollen season during at least the two previous seasons (definition of allergy severity according to ARIA (Bousquet et al, 2016))
-Patients treated with documented use of anti-allergic medication for at least 2 grass pollen seasons prior to enrollment
-A positive skin prick test (SPT - wheal diameter = 3 mm) to grass pollen mixture, histamine wheal = 3 mm, NaCl control reaction < 2 mm
-Specific Immunoglobulin E (IgE) against grass pollen mixture = 0.7 kU/L
•For patients with co-sensitization to ragweed or mugwort pollen allergens, the result of the SPT to ragweed or mugwort pollen has to be less (in mm wheal diameter) than the result to grass pollen
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 76
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Simultaneous participation in another clinical study or previous participation within 30 days before inclusion
•Previous fully accomplished immunotherapy of 2 years or more with grass allergens within the last 5 years
•Ongoing immunotherapy
•Subjects being in any relationship or dependence with the Sponsor, clinical research organization and/or Investigator
•Subjects for whom the Investigator believes he/she will not be able to comply with the study requirements, e.g. unreliable subjects, subjects with known alcoholism or drug abuse or with a history of a severe psychiatric disorder
•Subjects symptomatic to perennial inhaled allergens (house dust mites, cat, dog) to which the patients are regularly exposed
•Subjects symptomatic to ragweed or mugwort pollen allergens or expected to develop allergic symptoms to mugwort or ragweed pollen allergens during the study period
•Subjects with a documented history of IgE dependent anaphylaxis, including food (e.g. peanut or marine animals) or hymenoptera venom (e.g. bee or wasp stings) or medication (e.g. penicillin)
•Subjects with partly controlled or uncontrolled asthma according to Global Initiative For Asthma (GINA) guidelines (GINA steps 3-5, 2017) and/or with asthma or Chronic Obstructive Pulmonary Disease (COPD) with confirmed forced expiratory volume in 1 second (FEV1) < 70% of the predicted value (ECSC) or with a peak expiratory flow (PEF) <70% of the individual optimum value
•Subjects requiring any treatment with biologics, anti-IgE antibodies, mast cell stabilizers, anti-leukotriene agents
•Subjects suspected of having allergies to the drugs used during CPT (e.g. topical antihistamines or eye drops containing benzalkonium)
•Subjects with any contraindication for the use of adrenaline (in accordance with SmPC and including hyperthyroidism, uncontrolled hypertension) and/or requiring concomitant beta-blocking, angiotensin receptor blocker or angiotensin-converting-enzyme (ACE inhibitor) treatment
•Subjects with (repeated) laboratory abnormalities greater than CTCAE grade 2 or more at screening or known positive serology for Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus
•Concomitant ongoing treatment with H1 anti-histaminic drugs or corticosteroids (oral, topical or nasal) except for skin ointments for mild conditions as eczema
•Subjects with signs and symptoms of allergic conjunctivitis
•Subjects with any known eye diseases except for anomalies of refraction
•Subjects with any known ocular surface disease where IgE-mediated hypersensitivity is not involved (sicca syndrome, blepharitis, blepharo-conjunctivitis, urban eye syndrome, giant papillary conjunctivitis following intolerance to contact lenses or foreign bodies)
•Subjects with any surgery to the eye within 6 months prior to CPT
•Clinically relevant abnormalities in the 12-lead electrocardiogram (ECG)
•Subjects with ongoing malignant disease
•Subjects with an autoimmune disease and/or who are immunocompromised by medication or illness, or have received a vaccine or immunosuppressive medications within 30 days before study screening
•Subjects with any severe systemic pathology, or chronic disease which may impair the subject’s ability to participate in the study (e.g. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc.) including history of significant renal disease or chronic hepatic disease
•Diagnosis of ma
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to determine in patients with moderate to severe grass pollen allergic rhinoconjunctivitis (ARC) the concentrations of grass pollen allergen at which cumulatively 50% +/- 10% of patients respond after local application in a conjunctival provocation test (CPT).;Secondary Objective: Secondary objectives of this study are:<br>•Assessment of safety and local tolerability of the conjunctival provocation test solutions<br>•Determination of two concentrations of grass pollen allergens to which cumulatively 50%±10% of the patients respond in a CPT after administration of 50 µl<br>•Determination of three concentrations of grass pollen allergens to which cumulatively 95% of the patients respond in a CPT after administration of 50 µl<br>;Primary end point(s): The primary efficacy endpoint is the cumulative percentage of CPT responders in concentrations used in a CPT solution at V2.<br>;Timepoint(s) of evaluation of this end point: Visit V2
- Secondary Outcome Measures
Name Time Method