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: 20.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853
Conditions
Interventions
Product Name: gpCPT+
Pharmaceutical Form: Solution for provocation test
Sponsors
ASIT biotech S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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: o No medical history of moderate to severe persistent allergic rhinoconjunctivitis (ARC) for the grass pollen season o A negative skin prick test (SPT - wheal diameter =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: •Assessment of safety and local tolerability of the conjunctival provocation test solutions •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 •Determination of three concentrations of grass pollen allergens to which cumulatively 95% of the patients respond in a CPT after administration of 50 µl ;Primary end point(s): The primary efficacy endpoint is the cumulative percentage of CPT responders in concentrations used in a CPT solution at V2. ;Timepoint(s) of evaluation of this end point: Visit V2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints are: • Cumulative percentage of CPT responders at V3 to one of two concentrations selected according to the median (50% +/- 10%) reactivity observed at V2 and 1/9 of this concentration • Cumulative percentage of CPT responders at V3 to one of three concentrations selected according to the median (50% +/- 10%) reactivity observed at V2, 1/9 of this concentration and 9x of this concentration Further secondary endpoints are: • Number of patients responding at each dilution according to Riechelmann H et al, 2003 response staging • Number of patients in each response staging according to Riechelmann H et al, 2003 Safety/Tolerability endpoints are: • Frequency of Adverse events (AEs) concerning, seriousness, intensity and relationship to the CPT procedure • Frequency and grading of local reactions and systemic reactions • Blood pressure, pulse rate, body temperature, and breathing frequency and change thereof ;Timepoint(s) of evaluation of this end point: Timepoint for efficacy endpoints: V3 Timepoint for further secondary endpoints: V2, V3 Timepoint for Safety/Tolerability endpoints: V1, V2, V3 | — |
Countries
Germany
Contacts
Public ContactContract Research Organization
CRI - Clinical Research International Ltd.
Outcome results
None listed