Food Allergy to Fish Clinical Trial
— FASTIIbOfficial title:
A Multinational Phase IIb Study to Investigate the Efficacy and Safety of Subcutaneous Immunotherapy With a Modified Fish- Parvalbumin Given in Single Rising and Maintenance Doses to Subjects Allergic to Fish
| Verified date | June 2017 |
| Source | University of Athens |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 45 |
| Est. completion date | April 2017 |
| Est. primary completion date | February 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 immunological diseases, major cardiovascular disease, cancer, chronic infections, lack of compliance and severe psychological disorders. - Any significant clinical condition that the investigators judged might hamper the patient's safety or the study outcomes. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, mental disease, immunological and endocrine disease. - Chronic urticaria. - Severe atopic dermatitis or non-controlled atopic dermatitis. - Ongoing treatment with betablockers, angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor II antagonists (ARA II). - Pregnancy or nursing. - Uncontrolled asthma (asthma, if present, should be well controlled according to GINA guidelines using any kind of drugs except oral corticosteroids and omalizumab). - An FEV1<80% of predicted value during screening spirometry. - Subject who has participated in a clinical trial within 3 months prior to this one. - Subject with a history of drug or alcohol abuse. - Investigators, co-investigators, as well as their children or spouses and all the study collaborators should not be enrolled in the study. - Patients with concurrent allergy symptoms can be included if patients can manage without antihistamines and/or leukotriene receptor antagonists five days prior each screening and treatment visit. |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | National University Hospital NUHD Denmark | Gentofte | |
| Denmark | Odense University Hospital OUH Denmark | Odense | |
| Greece | Sotiria General Hospital for the Diseases of the Thorax | Athens | |
| Iceland | Landspitali University Hospital Reykjavik LSH Iceland | Reykjavik | |
| Netherlands | Universitiy Medical Centre Utrecht UMCU The Netherlands | Utrecht | |
| Poland | Medical Universtity of Lodz | Lodz | |
| Spain | Hospital Universitario Reina Sofia (Cordoba) Spain | Cordoba | |
| Spain | Hospital Clinico San Carlos SERMAS Spain | Madrid | |
| Spain | Hospital Regional Universitario de Malaga Spain | Malaga |
| Lead Sponsor | Collaborator |
|---|---|
| George Stavroulakis | Hospital Regional Universitario de Malaga Spain, Hospital San Carlos, Madrid, Hospital Universitario Reina Sofia (Cordoba) Spain, Landspitali University Hospital Reykjavik LSH Iceland, Medical Universtity of Lodz, National and Kapodistrian University of Athens, National University Hospital NUHD Denmark, Odense University Hospital OUH Denmark, Universitiy Medical Centre Utrecht UMCU The Netherlands |
Denmark, Greece, Iceland, Netherlands, Poland, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | The primary outcome measure will be efficacy as determined by the change from baseline in the threshold of fish protein that induces an allergic reaction. This threshold will be assessed by means of a standardized double blind placebo controlled food challenge (DBPCFC) with cod-fish after completion of six months of immunotherapy. Success is defined as a statistically significant change in the threshold dose of protein that provokes a reaction in DBPCFC. | 7 months after treatment begining | |
| Secondary | Safety (recording of adverse events)- Number of participants with adverse events and recording of the nature of adverse events | The fundamental secondary endpoint will be safety as indicated by clinical safety and tolerability and by the careful recording of adverse events; other surrogates of safety will be: physical examination, vital signs, 12-Lead ECG and laboratory evaluations. | Up to 13 months | |
| Secondary | Severity of reaction in food challenge | To study any possible change from baseline in the severity of the reaction in the baseline Double Blind Placebo Controled Food Challenge (DBPCFC) after treatment with mCyp c 1 | 7 months after treatment begining | |
| Secondary | Skin prick test (SPT) reactivity | To study any possible change(s) from baseline in skin prick test (SPT) reactivity against fish and mCyp c 1 (titrated) after treatment with mCyp c 1 | 7 months after treatment begining | |
| Secondary | Serum specific IgE, IgG, IgG4 and IgA antibodies | To study any possible change(s) from baseline in serum specific IgE, IgG, IgG4 and IgA antibodies against fish and rCyp c 1 (ImmunoCAP) after treatment with mCyp c 1 | 7 months after treatment begining | |
| Secondary | Biological activity of IgE | To study any possible change from baseline in the biological activity of IgE (stripped basophil histamine release test) after treatment with mCyp c 1 | 7 months after treatment begining |