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

NCT02382718 | Completed Phase 2 DMC

• 1 other identifier: FAST2015
• Study Type: interventional
• Target: 45
• Locations: 6 countries
• Sites: 9

Brief 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.

Conditions

Food Allergy to Fish

Keywords

fish allergy; parvalbumin; immunotherapy; mCyp c 1

Outcome Measures

Primary Outcomes (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)

  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 Outcomes (5)

• Safety (recording of adverse events)- Number of participants with adverse events and recording of the nature of adverse events

  Up to 13 months

• Severity of reaction in food challenge

  7 months after treatment begining

• Skin prick test (SPT) reactivity

  7 months after treatment begining

• Serum specific IgE, IgG, IgG4 and IgA antibodies

  7 months after treatment begining

• Biological activity of IgE

  7 months after treatment begining

Study Arms (2)

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).

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).

Biological: Placebo

Interventions

FAST fish mCyp c 1 BIOLOGICAL

Subcutaneous immunotherapy

Also known as: mCyp c 1

FAST fish mCyp c 1

Placebo BIOLOGICAL

Subcutaneous immunotherapy

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• George Stavroulakis: lead
• Hospital San Carlos, Madrid: collaborator
• Odense University Hospital: collaborator
• Medical University of Lodz: collaborator
• National and Kapodistrian University of Athens: collaborator
• Landspitali University Hospital: collaborator
• National University Hospital NUHD Denmark: collaborator
• UMC Utrecht: collaborator
• Hospital Universitario Reina Sofia (Cordoba) Spain: collaborator
• Hospital Regional de Malaga: collaborator

Study Sites (9)

National University Hospital NUHD Denmark

Gentofte Municipality, DK-2900, Denmark

Location

Odense University Hospital OUH Denmark

Odense, DK 5000, Denmark

Location

Sotiria General Hospital for the Diseases of the Thorax

Athens, 115 27, Greece

Location

Landspitali University Hospital Reykjavik LSH Iceland

Reykjavik, 101, Iceland

Location

Universitiy Medical Centre Utrecht UMCU The Netherlands

Utrecht, 85500, Netherlands

Location

Medical Universtity of Lodz

Lodz, Poland

Location

Hospital Universitario Reina Sofia (Cordoba) Spain

Córdoba, 14004, Spain

Location

Hospital Clinico San Carlos SERMAS Spain

Madrid, 28040, Spain

Location

Hospital Regional Universitario de Malaga Spain

Málaga, Spain

Location

Related Links

• FAST Consortium and FAST study website

Study Officials

• Ronald van Ree, Professor

  FAST Consortium under EU 7th FP

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: On behalf of the FAST Consortium: George Stavroulakis, MD, Allergist, Clinical Coordinator FAST phase IIb study

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: March 9, 2015
• Study Start: October 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: April 1, 2017
• Last Updated: June 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); NL (1); PL (1); ES (3); DK (2); IC (1)