This is a phase IIb clinical trial to investigate the efficacy and safety of subcutaneous immunotherapy with a modified parvalbumin called mCyp c 1 for the treatment of fish allergy to subjects allergic to fish.
Who can participate
Age range18 Years – 65 Years
SexALL
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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…
What they're measuring
1
Efficacy of subcutaneous immunotherapy with mCyp c 1 for the treatment of fish allergy (change from baseline in the threshold of fish protein that induces an allergic reaction)