Pilot Study on Immunotherapy for the Treatment of Persistant Peanut Allergy
Primary Purpose
Food Allergy, Peanut Allergy
Status
Terminated
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Peanut Immunotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Food Allergy
Eligibility Criteria
Inclusion Criteria:
- Informed Consent as documented by signature.
- Male or female subjects 12 to 45 years old at screening visit.
Patients with convincing history of IgE-mediated systemic allergic reaction after consumption of peanut, and specific IgE above 95% positive predictive value:
a. Peanut ≥ 15kU/L or Ara h 2 ≥ 5U/L
- Patients without a convincing history of IgE-mediated systemic allergic reaction (for example only oral symptoms) after consumption of peanuts but with clear evidence of sensitization (SPT > 3 mm and/or positive specific IgE (> 0.1kU/l) and a positive standardized food challenge to peanut between V0 and V1.
Exclusion Criteria:
- Subjects with a history of severe anaphylaxis to the incriminated food with the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence).
- Subjects with a history of systemic reaction to peanutskin prick test with commercial extract.
- Uncontrolled asthma (Forced expiratory volume at one second (FEV1) <70% of predicted value), active eosinophilic oesophagitis or any condition deemed incompatible by the investigator.
- Known or suspected systemic mastocytosis.
- Subject currently under allergen immunotherapy.
- Subject/parent with excessive anxiety unlikely to cope with study conditions as per investigator's opinion.
- Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study.
- Use of immunosuppression or immunomodulatory drug (including anti-IgE or anti-Tumor necrosis factor (TNF)) within 1 year prior to inclusion in study.
- Relative counter-indication or inability to use epinephrine auto-injector.
- Subjects receiving beta-blockers or angiotensin converting-enzyme (ACE) inhibitors.
- Women who are pregnant or breast feeding.
- Intention to become pregnant during the course of the study, or inadequate contraceptive measures for women of child-bearing age (contraceptive measures considered adequate are: intrauterine devices, hormonal contraceptives, such as contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release).
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.).
- Diseases with a contraindication for the use of adrenalin (e.g. hyperthyroidism, glaucoma).
- Known or suspected non-compliance, drug or alcohol abuse.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- Patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigators
Sites / Locations
- Pediatric allergy unit, Hôpitaux Universitaires de Genève (HUG)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Peanut allergenic extract
Arm Description
injected peanut extract.
Outcomes
Primary Outcome Measures
Result (positive or negative) and cumulative reaction threshold at 3 months peanut oral food challenge (OFC).
An unblinded evaluation of peanut OFC cumulative reaction threshold after 3 months of peanut immunotherapy.
Secondary Outcome Measures
Change in serum levels of allergen specific IgE and IgG4 after 6 weeks and 3 months of treatment compared to baseline peanut specific IgE and IgG4 after 3 months of treatment with peanut extract.
An evaluation of changes in serum levels of allergen specific IgE and IgG4 after 6 weeks and 3 months of treatment compared to baseline peanut specific IgE and IgG4 after 3 months of treatment with peanut extract.
Change in titrated skin prick test after 6 weeks and 3 months of treatment with peanut extract compared to baseline.
An evaluation of changes in titrated skin prick tests after 6 weeks and 3 months of treatment with peanut extract compared to baseline.
Incidence rate of treatment emergent adverse events during peanut immunotherapy
An unblinded evaluation of the safety of peanut immunotherapy as measured by the incidence of treatment-emergent adverse events (AEs and SAEs).
Full Information
NCT ID
NCT04974970
First Posted
July 16, 2021
Last Updated
August 24, 2023
Sponsor
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT04974970
Brief Title
Pilot Study on Immunotherapy for the Treatment of Persistant Peanut Allergy
Official Title
Pilot Study on Immunotherapy for the Treatment of Persistant Peanut Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
early termination due to insufficient recruitment
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
April 19, 2022 (Actual)
Study Completion Date
April 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this trial is to assess the safety and efficacy of peanut immunotherapy in children and adults with peanut allergy. Participants will receive immunotherapy with peanut every 2 weeks for a period of 3 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy, Peanut Allergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peanut allergenic extract
Arm Type
Experimental
Arm Description
injected peanut extract.
Intervention Type
Drug
Intervention Name(s)
Peanut Immunotherapy
Intervention Description
Treatment will be injected peanut extract every 2 weeks for a period of 3 months.
Primary Outcome Measure Information:
Title
Result (positive or negative) and cumulative reaction threshold at 3 months peanut oral food challenge (OFC).
Description
An unblinded evaluation of peanut OFC cumulative reaction threshold after 3 months of peanut immunotherapy.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in serum levels of allergen specific IgE and IgG4 after 6 weeks and 3 months of treatment compared to baseline peanut specific IgE and IgG4 after 3 months of treatment with peanut extract.
Description
An evaluation of changes in serum levels of allergen specific IgE and IgG4 after 6 weeks and 3 months of treatment compared to baseline peanut specific IgE and IgG4 after 3 months of treatment with peanut extract.
Time Frame
3 months
Title
Change in titrated skin prick test after 6 weeks and 3 months of treatment with peanut extract compared to baseline.
Description
An evaluation of changes in titrated skin prick tests after 6 weeks and 3 months of treatment with peanut extract compared to baseline.
Time Frame
3 months
Title
Incidence rate of treatment emergent adverse events during peanut immunotherapy
Description
An unblinded evaluation of the safety of peanut immunotherapy as measured by the incidence of treatment-emergent adverse events (AEs and SAEs).
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed Consent as documented by signature.
Male or female subjects 12 to 45 years old at screening visit.
Patients with convincing history of IgE-mediated systemic allergic reaction after consumption of peanut, and specific IgE above 95% positive predictive value:
a. Peanut ≥ 15kU/L or Ara h 2 ≥ 5U/L
Patients without a convincing history of IgE-mediated systemic allergic reaction (for example only oral symptoms) after consumption of peanuts but with clear evidence of sensitization (SPT > 3 mm and/or positive specific IgE (> 0.1kU/l) and a positive standardized food challenge to peanut between V0 and V1.
Exclusion Criteria:
Subjects with a history of severe anaphylaxis to the incriminated food with the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence).
Subjects with a history of systemic reaction to peanutskin prick test with commercial extract.
Uncontrolled asthma (Forced expiratory volume at one second (FEV1) <70% of predicted value), active eosinophilic oesophagitis or any condition deemed incompatible by the investigator.
Known or suspected systemic mastocytosis.
Subject currently under allergen immunotherapy.
Subject/parent with excessive anxiety unlikely to cope with study conditions as per investigator's opinion.
Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study.
Use of immunosuppression or immunomodulatory drug (including anti-IgE or anti-Tumor necrosis factor (TNF)) within 1 year prior to inclusion in study.
Relative counter-indication or inability to use epinephrine auto-injector.
Subjects receiving beta-blockers or angiotensin converting-enzyme (ACE) inhibitors.
Women who are pregnant or breast feeding.
Intention to become pregnant during the course of the study, or inadequate contraceptive measures for women of child-bearing age (contraceptive measures considered adequate are: intrauterine devices, hormonal contraceptives, such as contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release).
Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.).
Diseases with a contraindication for the use of adrenalin (e.g. hyperthyroidism, glaucoma).
Known or suspected non-compliance, drug or alcohol abuse.
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
Patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigators
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Christoph Caubet, MD
Organizational Affiliation
University Hospitals of Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric allergy unit, Hôpitaux Universitaires de Genève (HUG)
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Pilot Study on Immunotherapy for the Treatment of Persistant Peanut Allergy
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