Treatment of seasonal grass pollen-induced rhinoconjunctivitis MedDRA version: 21.1 Level: LLT Classification code 10019170 Term: Hay fever System Organ Class: 100000004870
Conditions
Sponsors
ASIT biotech S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria - Year 1 1) Female or male patients aged 18 to 64 years (inclusive); 2) Signed and dated Informed Consent Form (ICF) by a legally competent patient; 3) Good physical and mental health according to medical history, physical examination and vital signs; 4) Female patients who are: a. Not of childbearing potential, defined as: amenorrhea or post-menopausal (natural spontaneous amenorrhea for at least 12 months, or at least 6 weeks following surgical menopause), OR b. Naturally or surgically sterile (hysterectomy; bilateral salpingectomy or oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study screening), OR c. Non-pregnant, non-lactating with negative blood pregnancy test at the Screening visit and using at least one of the following contraceptive methods: i. Stable hormonal contraceptive for =90 days prior to the study (if =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria - Year 1 1) Diagnosis of mastocytosis; 2) Previous (within the last 5 years) immunotherapy with grass allergens; 3) Ongoing immunotherapy with grass allergens or any other allergens; 4) Patients with any history of anaphylaxis due to any cause; 5) Patients with a history of hypersensitivity to the excipients of the investigational product; 6) Patients with a forced expiratory volume in 1 second (FEV1) <80% of the predicted value (European Community for Steel and Coal [ECSC]) or with a peak expiratory flow (PEF) <70% of the individual optimum value at the Screening visit 7) History of being intubated with mechanical ventilator support or in intensive care unit for asthma at any point in the patient’s life; 8) History of emergency visit or hospital admission for asthma in the previous 12 months; 9) Clinical history of moderate to severe allergic rhinitis, as defined according to the ARIA classification of rhinitis, due to tree pollen near or overlapping the grass pollen season; 10) Clinical history of moderate to severe allergic rhinitis as defined according to the ARIA classification of rhinitis caused by an allergen to which the participant is regularly exposed; 11) Patients with a history of significant renal disease or chronic hepatic disease; 12) Patients with a malignant disease; 13) Patients with history of systemic disease affecting the immune system such as autoimmune diseases, immune complex disease or immunodeficiency, or with any chronic disease which may impair the patient’s ability to participate in the trial (e.g. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc.); 14) Patients requiring concomitant medications such as beta-blocking, angiotensin receptor antagonist or angiotensin-converting enzyme inhibitor treatment; antidepressant drugs with potent antihistamine properties i.e. tricyclic antidepressants (e.g. doxepin, amitriptyline, desipramine, imipramine, etc.); anti-IgE antibodies, mast cell stabilisers, anti-leukotriene agents or anti-interleukin treatment (e.g. anti-interleukin 5); corticosteroids (oral, topical or nasal); or H1 anti-histaminic drugs; 15) Patients with any contraindication for the use of adrenaline; 16) Patients with (repeated) laboratory abnormalities according to Common Terminology Criteria for Adverse Events higher than Grade 2 at Screening; 17) Patients with known positive serology for Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus; 18) Patients having received a vaccine, corticoids or immunosuppressive medications with significant systemic effect within 1 month before trial entry; 19) Patients being in any relationship with or being dependent on the Sponsor, Contract Research Organisation (CRO) and/or Investigator; 20) Inability to understand instructions, attend planned visits and/or complete study documents or assessments, including unreliable patients such as those with known alcoholism or drug abuse or with a history of a severe psychiatric disorder, as well as patients unwilling to give informed consent or to abide by the requirements of the protocol; 21) Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion; 22) Patients who have been committed to an institution by virtue of an order issued by either the judicial or the administrative authorities. Exclusion criteria (Year 2; extension) Pa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the clinical efficacy of grass pollen-ASIT+™ (gpASIT+™) following subcutaneous administration to patients suffering from grass pollen-induced allergic rhinoconjunctivitis, as assessed with the combined symptom and medication score (CSMS) during the peak of the grass pollen season in Year 1 (2019). ;Secondary Objective: · To confirm the clinical efficacy of gpASIT+™ as assessed with the CSMS during the entire grass pollen seasons in Year 1 (2019) and Year 2 (2020); · To confirm the clinical efficacy of gpASIT+™ as assessed with the Rhinoconjunctivitis Total Symptom Score (RTSS) and subscores, the Rescue Medication Score (RMS) and the rate of “well days”, during the grass pollen seasons (both peaks and entire seasons) in Year 1 (2019) and Year 2 (2020); · To confirm the safety and clinical tolerability of gpASIT+™ treatment after the first and second treatment courses; · To confirm the induction of key immunological effects in serum after treatment with gpASIT+™ after the first and second treatment courses; · To assess patients’ quality of life and the health economics impact of treatment with gpASIT+™ during the grass pollen seasons in Year 1 (2019) and Year 2 (2020); Additional objectives detailed in the Study Protocol.;Primary end point(s): The primary efficacy endpoint will be the average daily CSMS collected during the peak of the grass pollen season in Year 1. The daily CSMS is the sum of the daily symptom score and the daily RMS calculated from the data recorded in the eDiary.;Timepoint(s) of evaluation of this end point: Over the peak of the grass pollen season. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints for Year 1 are: • CSMS over the entire grass pollen season; • RTSS (i.e. the sum of ESS and NSS) over the peak period and the entire grass pollen season; RMS over the peak period and the entire grass pollen season; • Symptom subscores (ESS and NSS) over the peak period and the entire grass pollen season; • TSS (the sum of the ESS, NSS and lung symptom score) over the peak period and the entire grass pollen season (in asthmatic patients only); • Use of rescue medication to relieve asthma symptoms over the peak period and the pollen season; • Number (%) of “well days” over the peak period and the entire grass pollen season; • RQLQ(S); • PGE assessment. Secondary efficacy endpoints and analysis for Year 2 With the exception of the secondary analysis, the same statistical analyses will be used for both Year 1 and Year 2. The first efficacy endpoint for Year 2 will be the average daily CSMS collected during the peak of the grass pollen season in Year 2. An analysis of covariance (ANCOVA) similar to the one run for Year 1 will be applied. The LS mean from the ANCOVA and the corresponding two-sided 95% CI of the difference of LS means between the two treatment groups will be presented. If the 20% difference (0.30 in absolute value) is within the 95% CI, then the study will be declared positive because the observed treatment effect of Year 1 could be considered as sustained. The second efficacy analysis will be the evaluation of change within the gpASIT+™ group assessed through a paired comparison (repeated ANOVA) between Year 1 and Year 2 which allows a reliable assessment of efficacy improvement between the first and second season. To explore the change of the CSMS scores over the two pollen seasons in the non-treated group, the same analysis will be repeated within the placebo group. ;Timepoint(s) of evaluation of this end point: Over the peak period and the entire pollen season | — |
Countries
Belgium, Czech Republic, Germany, Hungary, Poland
Contacts
Public ContactClinical Operations
ASIT biotech S.A.
Outcome results
None listed