FAST Fish Phase IIb Clinical Trial for the Treatment of Fish Allergy by Subcutaneous Immunotherapy (FASTIIb)
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|ClinicalTrials.gov Identifier: NCT02382718|
Recruitment Status : Completed
First Posted : March 9, 2015
Last Update Posted : June 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Food Allergy to Fish||Biological: FAST fish mCyp c 1 Biological: Placebo||Phase 2|
Fish allergy is a persistent food allergy (usually lifelong) which can be life threatening due to the danger for anaphylaxis (severe allergic reaction) upon accidental exposure to fish. Until today there is no curative treatment for fish allergy. The only treatment is avoidance. Patients with fish allergy have to avoid fish of all types and carry an adrenaline autoinjector and rescue medication, in case of accidental exposure to fish. That way patients with fish allergy have to continuously control what they are eating and this causes a great deal of stress and impacts their quality of life.
The major allergen responsible for fish allergy is the protein parvalbumin. It is recognized by the vast majority (96-100%) of fish allergic patients.
During the past, treatment of food allergy with immunotherapy was successful but dangerous, due to serious side effects (anaphylaxis).
A novel biotechnological product, a recombinant hypoallergenic parvalbumin, called mCyp c 1, is used for the first time in a phase IIb clinical trial, to test the efficacy of subcutaneous immunotherapy for the treatment of fish allergy. The investigational medicinal product mCyp c1, is based on the recombinant wild type carp parvalbumin (rCyp c 1) and is the result of site directed mutagenesis, by which the disruption of the two calcium binding sites of carp parvalbumin is performed. The modified parvalbumin mCyp c 1, is both hypoallergenic and immunogenic. That way it is a promising molecule for the safe and effective treatment of fish allergy.
This molecule has proven to be safe in a phase I/IIa study that has been performed, during which mCyp c 1 was administered with subcutaneous injections. During this study only local reactions at the injection site were observed. There were no observed systemic reactions. Even more, there were clear indications that mCyp c 1 was recognized by the immune system. The results of this phase I/IIa study guarantee the necessity of a phase IIb clinical trial with mCyp c 1, in order to study the efficacy of this modified parvalbumin in the treatment of fish allergy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official 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|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||April 2017|
Experimental: FAST fish mCyp c 1
Subcutaneous injections of investigational medicinal product mCyp c 1 formulated in a solution (suspension) with aluminium.
Up-dosing (build-up) phase: each subject will receive 10 injections of active or placebo treatment. The first three injections will be given on the first day. For those on active treatment the dosing will begin at 6ng and conclude on week 8 with the administration of 60μg.
Maintenance phase: the maintenance dose of 60μg will be repeated once at two weeks and then monthly for a period of four months (four monthly injections).
Biological: FAST fish mCyp c 1
Other Name: mCyp c 1
Placebo Comparator: Placebo
Subcutaneous injections of exactly the same dosage, frequency and duration as Active Arm but all injections will be performed with placebo (has the same composition as the active drug suspension but no allergen mCyp c 1 is added).
- 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) [ Time Frame: 7 months after treatment begining ]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.
- Safety (recording of adverse events)- Number of participants with adverse events and recording of the nature of adverse events [ Time Frame: Up to 13 months ]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.
- Severity of reaction in food challenge [ Time Frame: 7 months after treatment begining ]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
- Skin prick test (SPT) reactivity [ Time Frame: 7 months after treatment begining ]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
- Serum specific IgE, IgG, IgG4 and IgA antibodies [ Time Frame: 7 months after treatment begining ]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
- Biological activity of IgE [ Time Frame: 7 months after treatment begining ]To study any possible change from baseline in the biological activity of IgE (stripped basophil histamine release test) after treatment with mCyp c 1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382718
|National University Hospital NUHD Denmark|
|Gentofte, Denmark, DK-2900|
|Odense University Hospital OUH Denmark|
|Odense, Denmark, DK 5000|
|Sotiria General Hospital for the Diseases of the Thorax|
|Athens, Greece, 115 27|
|Landspitali University Hospital Reykjavik LSH Iceland|
|Reykjavik, Iceland, 101|
|Universitiy Medical Centre Utrecht UMCU The Netherlands|
|Utrecht, Netherlands, 85500|
|Medical Universtity of Lodz|
|Hospital Universitario Reina Sofia (Cordoba) Spain|
|Cordoba, Spain, 14004|
|Hospital Clinico San Carlos SERMAS Spain|
|Madrid, Spain, 28040|
|Hospital Regional Universitario de Malaga Spain|
|Study Chair:||Ronald van Ree, Professor||FAST Consortium under EU 7th FP|