Study to investigate the efficacy and safety of a subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergy in comparison with a placebo

Phase 1

• Conditions: Treatment of seasonal grass pollen-induced rhinoconjunctivitis; MedDRA version: 20.0Level: LLTClassification code 10019170Term: Hay feverSystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2017-002911-33-HU
• Lead Sponsor: ASIT biotech S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-05
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 624

Inclusion Criteria

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 <90 days prior to the study, additional use of a double barrier method is required until 90 days are reached) and for =3 weeks after the final injection, OR
ii. Placement of an intrauterine device (IUD) or intrauterine hormone-releasing
system, OR
iii. Successful male sterilisation of the sole sexual partner (patient must verbally
confirm that appropriate post-vasectomy documentation of the absence of sperm in the ejaculate was provided), OR
iv. True abstinence when in line with the preferred and usual lifestyle of the patient. Periodic abstinence such as calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception.
5) Allergy diagnosis:
a. A clinical history of moderate to severe grass pollen-induced SARC for at least 2 pollen seasons, requiring treatment with either antihistamines or nasal corticosteroids during the 2017 and 2018 grass pollen seasons and with symptoms interfering with usual daily activities or with sleep, as defined according to Allergic Rhinitis and its Impact on Asthma (ARIA) classification of rhinitis (Bousquet et al. 2001; Brozèk et al. 2017, see Chapter VIII.3.2) AND
b. A positive SPT (wheal diameter =3 mm) to grass pollen mixture, histamine wheal =3 mm, sodium chloride (NaCl) control reaction <2 mm AND
c. Specific IgE against grass pollen =0.7 kU/L.
6) For asthmatic patients, confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA; 2018) guidelines (Steps 1 to 3, see Chapter VIII.3.2).
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 624
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 greater than Common Terminology Criteria for Adverse Events Grade 2 or higher 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified