Trial Outcomes & Findings for Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergy: a Pilot Study (NCT NCT02149719)

Results Overview

The proportion of participants who tolerate 1.4g (or more) roasted peanut protein after 12 months of OIT as assessed by DBPCFC, in the active vs control group.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

12 months

Results posted on

2024-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	Desensitisation to Peanut Desensitisation using boiled peanut	Control Subjects allocated to the control group will undergo routine care for 12 months, following which they will be offered the active treatment with boiled peanut (as a one-way cross-over intervention). Desensitisation using boiled peanut (deferred start)
Overall Study STARTED	32	15
Overall Study COMPLETED	24	14
Overall Study NOT COMPLETED	8	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Desensitisation to Peanut n=32 Participants Desensitisation using boiled peanut Desensitisation using boiled peanut	Control n=15 Participants Subjects allocated to the control group will undergo routine care for 12 months, following which they will be offered the active treatment with boiled peanut (as a one-way cross-over intervention). Desensitisation using boiled peanut (deferred start)	Total n=47 Participants Total of all reporting groups
Age, Continuous	12.5 years n=32 Participants	12.5 years n=15 Participants	12.5 years n=47 Participants
Sex: Female, Male Female	11 Participants n=32 Participants	9 Participants n=15 Participants	20 Participants n=47 Participants
Sex: Female, Male Male	21 Participants n=32 Participants	6 Participants n=15 Participants	27 Participants n=47 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	32 Participants n=32 Participants	15 Participants n=15 Participants	47 Participants n=47 Participants
Diagnosis of asthma	20 Participants n=32 Participants	12 Participants n=15 Participants	32 Participants n=47 Participants
Previous anaphylaxis to peanut	14 Participants n=32 Participants	5 Participants n=15 Participants	19 Participants n=47 Participants
Skin prick test to commercial peanut allergen	9 mm skin wheal n=32 Participants	9 mm skin wheal n=15 Participants	9 mm skin wheal n=47 Participants
Serum IgE to peanut	32.9 kUA/lL n=32 Participants	38.7 kUA/lL n=15 Participants	35.8 kUA/lL n=47 Participants
Serum IgE to ara h 2	17 kUA/lL n=32 Participants	32.8 kUA/lL n=15 Participants	17.4 kUA/lL n=47 Participants

PRIMARY outcome

Timeframe: 12 months

The proportion of participants who tolerate 1.4g (or more) roasted peanut protein after 12 months of OIT as assessed by DBPCFC, in the active vs control group.

Outcome measures

Outcome measures
Measure	Desensitisation to Peanut n=32 Participants Desensitisation using boiled peanut	Control n=15 Participants Subjects allocated to the control group will undergo routine care for 12 months, following which they will be offered the active treatment with boiled peanut (as a one-way cross-over intervention). Desensitisation using boiled peanut (deferred start)
Desensitisation to >1.4g (Roasted) Peanut Protein at Food Challenge	24 Participants	14 Participants

SECONDARY outcome

Timeframe: 6 and 12 months after study intervention

Relative change in clinical threshold (No observed adverse event level, NOAEL; Lowest observed adverse event level, LOAEL) to roasted peanut at 6 and 12 months.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After 1 year of OIT

Rate of sustained unresponsiveness after 4 week cessation of maintenance OIT at 1 year.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Incidence of adverse allergic events during desensitisation protocol

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6, 12 and 24 months

Quality of Life assessment and how this changes during peanut desensitisation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Compliance with study protocol

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre, 3, 6, and 12 months post start of OIT

Immunological outcome measures pre-, during and post- 12 months of OIT

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Change in threshold in peanut-allergic subjects found to be tolerant to boiled peanut at baseline, as determined by double-blind, placebo-controlled food challenges pre- and post- desensitisation.

Outcome measures

Outcome data not reported

Adverse Events

Desensitisation to Peanut

Serious events: 17 serious events

Other events: 32 other events

Deaths: 0 deaths

Control - Avoidance Phase

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Control - Desensitisation Phase

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Desensitisation to Peanut n=32 participants at risk Desensitisation using boiled peanut	Control - Avoidance Phase n=15 participants at risk Subjects allocated to the control group will undergo routine care for 12 months, following which they will be offered the active treatment with boiled peanut (as a one-way cross-over intervention).	Control - Desensitisation Phase n=15 participants at risk Subjects allocated to the control group underwent routine care (dietary avoidance) for 12 months, following which they were offered active treatment with boiled peanut (as a one-way cross-over intervention).
Immune system disorders Uncomplicated anaphylaxis at hospital food challenge	37.5% 12/32 • Number of events 25 • 1 year (2 years in control arm)	40.0% 6/15 • Number of events 10 • 1 year (2 years in control arm)	0.00% 0/15 • 1 year (2 years in control arm)
Immune system disorders Anaphylaxis due to dosing at home	34.4% 11/32 • Number of events 21 • 1 year (2 years in control arm)	0.00% 0/15 • 1 year (2 years in control arm)	20.0% 3/15 • Number of events 4 • 1 year (2 years in control arm)
Immune system disorders Anaphylaxis not related to study intervention	3.1% 1/32 • Number of events 2 • 1 year (2 years in control arm)	0.00% 0/15 • 1 year (2 years in control arm)	6.7% 1/15 • Number of events 1 • 1 year (2 years in control arm)

Other adverse events

Other adverse events
Measure	Desensitisation to Peanut n=32 participants at risk Desensitisation using boiled peanut	Control - Avoidance Phase n=15 participants at risk Subjects allocated to the control group will undergo routine care for 12 months, following which they will be offered the active treatment with boiled peanut (as a one-way cross-over intervention).	Control - Desensitisation Phase n=15 participants at risk Subjects allocated to the control group underwent routine care (dietary avoidance) for 12 months, following which they were offered active treatment with boiled peanut (as a one-way cross-over intervention).
Immune system disorders Allergic reaction due to study intervention	100.0% 32/32 • Number of events 1017 • 1 year (2 years in control arm)	0.00% 0/15 • 1 year (2 years in control arm)	80.0% 12/15 • Number of events 115 • 1 year (2 years in control arm)

Additional Information

Dr Paul Turner

Imperial College London

Phone: +44 20 3312 7754

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place