A multicentre, international, randomised, double-blind, placebo controlled study to demonstrate the clinical efficacy and safety of subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergic rhinoconjunctivitis

ASIT biotech S.A.0 sites624 target enrollmentJuly 9, 2018

Overview

No summary available.

Registry

who.int

Start Date

July 9, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

ASIT biotech S.A.

•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
•iii. Successful male sterilisation of the sole sexual partner (patient must verbally

•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;