Trial Outcomes & Findings for Peanut Oral Immunotherapy (OIT) - Initial Pilot Study in Adults (NCT NCT01274429)

Last Updated: 2018-03-27

Results Overview

Assess mg of peanut tolerated on double-blind placebo-controlled food challenge as a measure of desensitization and tolerance

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

5 participants

Primary outcome timeframe

2-3 years

Results posted on

2018-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	Open Label Peanut Flour Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
Overall Study STARTED	5
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Open Label Peanut Flour Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
Overall Study Study closed do to lack of funding	5

Baseline Characteristics

Peanut Oral Immunotherapy (OIT) - Initial Pilot Study in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label Peanut Flour n=5 Participants Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose. Peanut flour: Peanut flour that is ingested daily and administered in gradually increasing amounts up to a maximum maintenance dose.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	19.5 years n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Region of Enrollment United States	5 participants n=99 Participants

PRIMARY outcome

Timeframe: 2-3 years

Population: No subjects reached the end of study food challenge prior to closure of the study and therefore no data was collected towards this endpoint.

Assess mg of peanut tolerated on double-blind placebo-controlled food challenge as a measure of desensitization and tolerance

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2-3 years

Population: No subjects reached the end of study prior to closure of the study and therefore no end of treatment mechanistic data was collected in order to compare against the baseline.

Measure changes over the course of treatment in serum specific IgE and IgG4, skin prick tests, TH1 and TH2 cytokines, and CD4+ CD25+ FoxP3+ regulatory T cells

Outcome measures

Outcome data not reported

Adverse Events

Open Label Peanut Flour

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Open Label Peanut Flour n=5 participants at risk Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
Gastrointestinal disorders Vomiting	0.00% 0/5 • 2.5 years
Gastrointestinal disorders Diarrhea	20.0% 1/5 • 2.5 years
Skin and subcutaneous tissue disorders Erythematous rash	40.0% 2/5 • 2.5 years
Respiratory, thoracic and mediastinal disorders Rhinorrhea	40.0% 2/5 • 2.5 years
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/5 • 2.5 years
Respiratory, thoracic and mediastinal disorders Oropharyngeal itching	20.0% 1/5 • 2.5 years
Respiratory, thoracic and mediastinal disorders Sneezing	40.0% 2/5 • 2.5 years
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5 • 2.5 years
Respiratory, thoracic and mediastinal disorders Nose itch	20.0% 1/5 • 2.5 years
Skin and subcutaneous tissue disorders Skin itch	0.00% 0/5 • 2.5 years
Skin and subcutaneous tissue disorders Lip or eye swelling	0.00% 0/5 • 2.5 years
Eye disorders Eye itch	0.00% 0/5 • 2.5 years
Eye disorders Eye tearing	0.00% 0/5 • 2.5 years
Skin and subcutaneous tissue disorders Hives	20.0% 1/5 • 2.5 years
Gastrointestinal disorders Abdominal pain	40.0% 2/5 • 2.5 years
Respiratory, thoracic and mediastinal disorders Nasal congestion	40.0% 2/5 • 2.5 years

Additional Information

Dr. Edwin Kim, Director of the UNC Food Allergy Initiative

University of North Carolina at Chapel Hill

Phone: 919-843-9087

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place