Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001288819p
Ethics application status
Submitted, not yet approved
Date submitted
8/07/2021
Date registered
23/09/2021
Date last updated
23/06/2024
Date data sharing statement initially provided
23/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An open FEAsibility study of a ShorT duration peanut oral immunotherapy (OIT) for inducing sustained unresponsiveness / remission of peanut allergy (FEAST).
Scientific title
An open FEAsibility study of a ShorT duration peanut OIT for inducing sustained unresponsiveness / remission of peanut allergy in children aged 1 to 10 (FEAST).
Secondary ID [1] 304746 0
none
Universal Trial Number (UTN)
Trial acronym
FEAST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peanut Allergy 322778 0
Condition category
Condition code
Inflammatory and Immune System 320366 320366 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
FEAST trial
Peanut allergic participants aged 1 year old and up to and including 10 years old.
Participants will commence the study on the RUSH day (rapid updosing schedule day) where increasing doses of peanut flour (commencing at 0.1mg up to 12mg) are mixed in a food the child enjoys (eg yoghurt) and given. If the participant tolerates all of the doses they will commence dose 9 the following day for a period of two weeks. If the participant reacts to a dose, they will go home on the previous dose. For example, if they react to dose 4, they will go home on dose 3, commencing the following day for a period of two weeks. The balance of the RUSH doses will be incorporated into their build up schedule.
For all study treatment we have a stopping criteria that dictates when to stop study treatment. symptoms may include vomiting, severe abdominal pain, widespread hives etc.
All participants (regardless of what dose they went home on RUSH day) will continue to come back every two weeks for up-dosing in hospital until the maintenance dose is reached (2000 mg). Once the maintenance dose is reached, they will come in every 12 weeks for a review of treatment until a total of 12 months is complete.
If the participant is having trouble reaching maintenance dose within the prescribed timeframe their progress will be discussed and decided by the PI. In this case treatment will not be extended past 12 months.
Once the 12 months of treatment has been completed, the participants will have a double-blind placebo-controlled food challenge (DBPCFC) to check to see if they have been desensitised. Peanut flour will be used to challenge on the active day and a maltodextrin placebo will be used on the placebo day. First dose of the challenge will be 80mg with the top dose being 2500mg. If they pass this challenge, they will return for another DBPCFC 8 weeks later to see if they have achieved sustained unresponsiveness. If they fail the first challenge, they will come back 8 weeks later for an appointment but no DBPCFC will be performed. For those not completing the food challenge, a blood sample will be taken, a skin prick test performed and questionnaires administered.
There will be a follow up visit 12 months after the completion of study treatment
Intervention code [1] 321118 0
Treatment: Other
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328209 0
If sustained unresponsiveness is achieved 8 weeks after 12 months of peanut OIT treatment in peanut allergic children. This will be determined by the outcome of the DBPCFC
Timepoint [1] 328209 0
8 weeks after 12 months of OIT treatment
Secondary outcome [1] 398069 0
If desensitisation is achieved 8 weeks after 12 months of peanut OIT treatment in peanut allergic children. This will be determined by the outcome of the DBPCFC
Timepoint [1] 398069 0
8 weeks after 12 months of peanut OIT treatmen
Secondary outcome [2] 398070 0
Change from baseline in peanut skin prick test (SPT) at the end-of-treatment and 8-weeks post treatment
Timepoint [2] 398070 0
At baseline and at the end-of-treatment and 8-weeks post treatment
Secondary outcome [3] 398071 0
Change from baseline in blood sIgE and sIgG4 at the end-of-treatment and 8-weeks post treatment. This is a composite outcome
Timepoint [3] 398071 0
At baseline and at the end-of-treatment and 8-weeks post treatment.
Secondary outcome [4] 398072 0
Change from baseline in quality of life (Qol) scores at end-of-treatment and 8-weeks post treatment.
Timepoint [4] 398072 0
At baseline and at end-of-treatment and 8-weeks post treatment.
Secondary outcome [5] 398073 0
Incidence and severity of treatment emergent adverse events (TEAEs). This is a composite outcome. They will be assessed by a study doctor based upon the NIH NIAID Consortium for Food Allergy Research specific grading system for allergic reactions
Timepoint [5] 398073 0
At end of trial

Eligibility
Key inclusion criteria
Aged 1 to10 years.
Greater than 7kg (the weight considered safe for the administration of an Epipen/EpiPen Jr);
Confirmed diagnosis of peanut allergy as defined by a failed DBPCFC with peanut and a positive SPT or sIgE to peanut at screening;
Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf.
Minimum age
1 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than three doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)

Severe anaphylaxis during the study entry DBPCFC (defined as persistent hypotension, collapse, loss of consciousness, persistent hypoxia, or requiring more than 3 doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)

FEV1 greater than 85 percent at rest and FEV1/FVC equal to 85 percent at rest or ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines)

Underlying medical conditions (e.g. cardiac disease) that increase the risks associated with anaphylaxis

Use of beta-blockers, and ACE inhibitors

Reacting to the placebo component during the study entry DBPCFC

Have received other food immunotherapy treatment in the preceding 12 months

Currently taking immunomodulatory therapy (including allergen immunotherapy)

Past or current major illness that in the opinion of the Site Investigator may affect the subject’s ability to participate in the study e.g. increased risk to the participant

Subjects who in the opinion of the Site Investigator are unable to follow the protocol

Another family member already enrolled in the trial (to maintain safety)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
no sequencing required
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary analysis of all outcome data will include all enrolled participants where outcome data are available.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Trial never commenced recruitment
Date of first participant enrolment
Anticipated
18/10/2021
Actual
Date of last participant enrolment
Anticipated
1/03/2022
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19947 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 34653 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 309117 0
Other Collaborative groups
Name [1] 309117 0
Murdoch Children's Research Institute
Country [1] 309117 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Murdoch Children's Research Institute
Address
50 Flemington Road,
Parkville, 3052, Victoria
Country
Australia
Secondary sponsor category [1] 310068 0
None
Name [1] 310068 0
none
Address [1] 310068 0
none
Country [1] 310068 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308986 0
The Royal Children's Hospital Ethics committee
Ethics committee address [1] 308986 0
Ethics committee country [1] 308986 0
Australia
Date submitted for ethics approval [1] 308986 0
08/07/2021
Approval date [1] 308986 0
Ethics approval number [1] 308986 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112562 0
Dr Adriana Lozinsky
Address 112562 0
Murdoch Children's Research Institute
50 Flemington Road,
Parkville, Vic, 3052
Country 112562 0
Australia
Phone 112562 0
+61 393456068
Fax 112562 0
Email 112562 0
[email protected]
Contact person for public queries
Name 112563 0
Sigrid Pitkin
Address 112563 0
Murdoch Children's Research Institute
50 Flemington Road,
Parkville, Vic, 3052
Country 112563 0
Australia
Phone 112563 0
+61 393456068
Fax 112563 0
Email 112563 0
[email protected]
Contact person for scientific queries
Name 112564 0
Sigrid Pitkin
Address 112564 0
Murdoch Children's Research Institute
50 Flemington Road,
Parkville, Vic, 3052
Country 112564 0
Australia
Phone 112564 0
+61 393456068
Fax 112564 0
Email 112564 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
currently undergoing a patent application


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.