A prospective, randomized, double-blind placebo-controlled multi-centre dose-finding study of 3 different regimens of gpASIT+TM administered subcutaneously to adult patients suffering from hay fever

• Conditions: Treatment of seasonal grass pollen rhinoconjunctivitis; MedDRA version: 16.1Level: LLTClassification code 10019170Term: Hay feverSystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2013-005445-37-DE
• Lead Sponsor: BioTech Tools s.a.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-20
• Last Update Posted: 14 April 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients must meet all the following inclusion criteria in order to participate in this study
•Signed and dated Informed Consent Form by a legally competent patient
•Female or male patients aged 18–70 years
•The patients are in good physical and mental health according to his/her medical history and vital signs
•Non-pregnant, non-lactating females with adequate contraception
•Also females unable to bear children (i.e. tubule ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period)) must have signed the form adequate contraceptive protection”)
•Allergy diagnosis:
oA medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SAR) for the grass pollen season (definition of allergy severity according to ARIA (Bousquet et al 2001)) during at least the two previous years
oA positive skin prick test (wheal diameter = 3 mm) to grass-pollen mixture, histamine wheal = 3 mm, NaCl control reaction < 2 mm
oSpecific IgE (s-IgE) against grass pollen > 0.7 kU/L.
oPositive response to conjunctival provocation testing with at least 10,000 SQ-E/ml of grass allergens at both visits V1 AND V2.
Additionally the difference in reacting concentration at visits V1 and V2 must not exceed one step of allergen concentration. Otherwise, the test will be considered as irregular and the patient must be excluded.
In the case that there is a difference between the reactive concentrations at visit V1 and V2 the higher concentration will be assumed as baseline reactivity.
•Patients treated with anti-allergic medication for at least 2 years prior to enrolment
•In asthmatic patients: Confirmed diagnosis of controlled asthma according to GINA-guidelines (GINA 2012)

For all patients with co-sensitizations to birch pollen allergens all of the following criteria must be fullfilled:
•The result of the skin prick test to birch pollen has to be less than the result to grass pollen
•The specific IgE level to birch pollen allergens has to less than the s-IgE level to grass (the CAP RAST class for grass has to be at least 1 CAP RAST class higher than the CAP RAST class to birch)
•Patients with co-sensitization against birch pollen allergens must not suffer from typical rhinoconjunctivitis symptoms in spring time
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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion
•Previous immunotherapy with grass allergens within the last 5 years
•Ongoing immunotherapy
•Patients being in any relationship or dependence with the Sponsor, CRO and/ or Investigator
•Inability to understand instructions/ study documents
•Patients with a history of hypersensitivity to the excipients of investigational product (gpASIT+TM or placebo)
•Patients with partly controlled or uncontrolled asthma (as defined in: Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2012. Available from http://www.ginasthma.org)
•Patients with chronic asthma or emphysema, particularly with a FEV 1 <80% of the predicted value (ECSC) or with PEF < 70% of the individual optimum value
•Patients symptomatic to perennial inhalant allergens to which the patients are regularly exposed
•Patients with a history of significant renal disease or chronic hepatic disease
•Patients with malignant disease
•Patients with a known severe autoimmune disease
•Patients with any chronic disease which may impair the patient’s ability to participate in the trial (i.e. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc…)
•Patients requiring beta-blockers/ACE-inhibitors medication
•Patients requiring anti-IgE antibodies, mast cell stabilizers, and antileukotriene agents
•Patients with any contraindication for the use of adrenaline
•Patients with febrile illness (> 37.5°C, oral)
•Patients with a known positive serology for HIV-1/2, HBV or HCV
•Patients who are immunocompromised by medication or illness, have received a vaccine corticoids or immunosuppressive medications within 1 month before trial entry
•Female patients who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method
•Consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within time period preceding the trial (screening visit), as defined in VIII.6
•Patients with laboratory values greater than grade 1 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007)
•Unreliable patients including non-compliant patients, patients with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as patients unwilling to give informed consent or to abide by the requirements of the protocol

Study & Design

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