Food Allergy to FishPhase 2FASTIIbNCT02382718
FAST Fish Phase IIb Clinical Trial for the Treatment of Fish Allergy by Subcutaneous Immunotherapy
A Phase 2 study testing FAST fish mCyp c 1 in people with Food Allergy to Fish, run by George Stavroulakis at 9 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Food Allergy to Fish
- What is being tested?
- FAST fish mCyp c 1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 9 sitesin 6 countries
- Study dates
- Oct 2015to Apr 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
Spain3 sites
Hospital Universitario Reina Sofia (Cordoba) Spain
Córdoba, 14004
Hospital Clinico San Carlos SERMAS Spain
Madrid, 28040
Hospital Regional Universitario de Malaga Spain
Málaga
Denmark2 sites
National University Hospital NUHD Denmark
Gentofte Municipality, DK-2900
Odense University Hospital OUH Denmark
Odense, DK 5000
Greece1 site
Sotiria General Hospital for the Diseases of the Thorax
Athens, 115 27
Iceland1 site
Landspitali University Hospital Reykjavik LSH Iceland
Reykjavik, 101
Netherlands1 site
Universitiy Medical Centre Utrecht UMCU The Netherlands
Utrecht, 85500
About this study
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
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.
Read the detailed description
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.
- Conditions
- Food Allergy to Fish
- Being tested
- FAST fish mCyp c 1, Placebo
- Keywords
- fish allergy, parvalbumin, immunotherapy, mCyp c 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAST fish mCyp c 1Biological
Also called mCyp c 1
Subcutaneous immunotherapy
PlaceboBiological
Subcutaneous immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| FAST fish mCyp c 1 | Experimental | 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). Receives: Biological: FAST fish mCyp c 1 |
| Placebo | Placebo comparator | 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). Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months after treatment begining
Secondary outcomes (5)
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.
Measured: Up to 13 months
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
Measured: 7 months after treatment begining
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
Measured: 7 months after treatment begining
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
Measured: 7 months after treatment begining
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
Measured: 7 months after treatment begining
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy to FishStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Stavroulakis
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital San Carlos, Madrid, Odense University Hospital, Medical University of Lodz, National and Kapodistrian University of Athens, Landspitali University Hospital, National University Hospital NUHD Denmark, UMC Utrecht, Hospital Universitario Reina Sofia de Cordoba, Hospital Regional de Malaga
- Responsible party
- Sponsor-investigator, George Stavroulakis, University of Athens
- Investigators
- Ronald van Ree, Professor, Study chair, FAST Consortium under EU 7th FP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382718
- Sponsor's protocol ID
- FAST2015
- Acronym
- FASTIIb
- Status last verified
- Jun 2017
- First submitted
- 18 Feb 2015
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02382718
- Acronym / sponsor ID
- FASTIIb / FAST2015
- Conditions
- Food Allergy to Fish
- Keywords
- fish allergy, parvalbumin, immunotherapy, mCyp c 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- George StavroulakisUniversity, hospital or other
- Collaborators
- Hospital San Carlos, Madrid, Odense University Hospital, Medical University of Lodz, National and Kapodistrian University of Athens, Landspitali University Hospital, National University Hospital NUHD Denmark, UMC Utrecht, Hospital Universitario Reina Sofia de Cordoba, Hospital Regional de Malaga
- Study start
- Oct 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAST fish mCyp c 1 | Experimental | Biological: FAST fish mCyp c 1Subcutaneous 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). |
| Placebo | Placebo comparator | Biological: PlaceboSubcutaneous 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAST fish mCyp c 1Also: mCyp c 1Subcutaneous immunotherapy | Biological | FAST fish mCyp c 1 |
| PlaceboSubcutaneous immunotherapy | Biological | Placebo |
Primary outcome
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.
5 secondary outcomes
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
Severity of reaction in food challenge
Time frame: 7 months after treatment begining
Skin prick test (SPT) reactivity
Time frame: 7 months after treatment begining
Serum specific IgE, IgG, IgG4 and IgA antibodies
Time frame: 7 months after treatment begining
Biological activity of IgE
Time frame: 7 months after treatment begining
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- FAST Consortium and FAST study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Food Allergy to Fish
Not yet recruitingObservational study
FASC: Fish Allergy in Spanish Children - A Study of New Cases of Fish Allergy in Children and Adolescents
Fish Allergy, Food Hypersensitivity
Active, not recruiting
Fish Oral Immunotherapy in Hong Kong Children
Fish Allergy, Food Allergy in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald van Ree, Professor study chair
FAST Consortium under EU 7th FP
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FAST fish mCyp c 1 in people with Food Allergy to Fish, run by George Stavroulakis at 9 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, Denmark, Greece, Iceland, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.