EUCTR2015-002105-11-ES
Active, not recruiting
Phase 1
A multicenter, international, randomised, double-blind, placebo controlled study to demonstrate the clinical efficacy and safety of a subcutaneous immunotherapy with gpASIT+TM in patients with grass pollen-induced allergic rhinoconjunctivitis - BTT-gpASIT009_phase III
BioTech Tools S.A.0 sites654 target enrollmentJuly 31, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Treatment of seasonal grass pollen rhinoconjunctivitis
- Sponsor
- BioTech Tools S.A.
- Enrollment
- 654
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Signed and dated Informed Consent Form by a legally competent patient
- •\- Female or male patients aged 18\-64 years
- •\- The patients are in good physical and mental health according to his/her medical history and vital signs
- •\- For Females: non\-pregnant, non\-lactating females with adequate contraception or females unable to bear children (i.e. tubul ligation, hysterectomy, or post\-menopausal (defined as a minimum of one year since the last menstrual period))
- •\- Allergy diagnosis:
- •o A medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SARC) for the grass pollen season during at least the two previous seasons (definition of allergy severity according to ARIA (Bousquet et al 2001\))
- •o A positive skin prick test (SPT \- wheal diameter ? 3 mm) to grass pollen mixture, histamine wheal ? 3 mm, NaCl control reaction \< 2 mm
- •o Specific IgE against grass pollen (with recombinant allergens \- g213\) \> 0\.7 kU/L.
- •o Positive response to CPT with at least 10,000 SQ\-E/mL of grass allergens
- •\- Patients treated with anti\-allergic medication for at least 2 grass pollen seasons prior to enrollment
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 with grass allergens or any other allergens
- •\- 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 anaphylaxis, including food (e.g. peanut or marine animals) or hymenoptera venom (e.g. bee or wasp stings) or medication (e.g. penicillin)
- •\- Patients with a history of hypersensitivity to the excipients of the investigational product (gpASIT\+TM or placebo)
- •\- Patients with partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014\).
- •\- Patients with chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1\) \< 80% of the predicted value (ECSC) or with a peak expiratory flow (PEF) \< 70% of the individual optimum value
- •\- Patients symptomatic to inhaled allergens circulating during the grass pollen season (specific to each country: e.g. birch, hazel, mugwort, ragweed, olive, Alternaria alternata)
Outcomes
Primary Outcomes
Not specified
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