FAST Fish Phase IIb Clinical Trial for the Treatment of Fish Allergy by Subcutaneous Immunotherapy

Inclusion Criteria: * Subject having given a written informed consent before completing any study related procedure. * Male or female subject from 18 to 65 years old and in general good health as determined by past medical history and physical examination. * For woman of child bearing potential: * a negative urine pregnancy test at screening visit, * the subject must receive/ use a medically effective contraceptive method during the study. * Convincing case history of allergy (immediate allergic reaction ≤ 2 hours) to fish ingestion. * Specific IgE to fish by both a positive (3mm mean wheal diameter over negative control) SPT to cod extract and an ImmunoCAP ≥ class 2 (0.70 kUA/L) for cod (f3) and rCyp c 1 at screening. * Positive DBPCFC with cod at screening visits. * FEV1 ≥ 80% of predicted values at screening. * Subject accepting to comply fully with the protocol. Exclusion Criteria: * Placebo-reaction in DBPCFC. * Food anaphylaxis: anaphylactic shock (a score of 2 or 3 on cardiovascular/ neurologic symptoms according to PRACTALL (1): score 2 = drop in blood pressure and/or \>20% from baseline, or significant change in mental status- score 3 = cardiovascular collapse, signs of impaired circulation/ unconscious) due to fish intake, both during the past and at screening DBPCFC. * Ongoing immunotherapy (IT) with any kind of allergen. * Ongoing or previous treatment with omalizumab. * Any clinical condition that contraindicates IT (EAACI guidelines) (8): serious immunol…