- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04974970
Pilot Study on Immunotherapy for the Treatment of Persistant Peanut Allergy
August 24, 2023 updated by: Jean-Christoph Caubet, University Hospital, Geneva
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jean-Christoph Caubet, MD
- Phone Number: +41 79 553 40 85
- Email: Jean-Christoph.Caubet@hcuge.ch
Study Contact Backup
- Name: François Graham, MD, MSc
- Phone Number: 21534 15148908000
- Email: francois.graham.med@ssss.gouv.qc.ca
Study Locations
-
-
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Geneva, Switzerland, 1211
- Pediatric allergy unit, Hôpitaux Universitaires de Genève (HUG)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 45 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Peanut allergenic extract
injected peanut extract.
|
Treatment will be injected peanut extract every 2 weeks for a period of 3 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Result (positive or negative) and cumulative reaction threshold at 3 months peanut oral food challenge (OFC).
Time Frame: 3 months
|
An unblinded evaluation of peanut OFC cumulative reaction threshold after 3 months of peanut immunotherapy.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 3 months
|
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.
|
3 months
|
Change in titrated skin prick test after 6 weeks and 3 months of treatment with peanut extract compared to baseline.
Time Frame: 3 months
|
An evaluation of changes in titrated skin prick tests after 6 weeks and 3 months of treatment with peanut extract compared to baseline.
|
3 months
|
Incidence rate of treatment emergent adverse events during peanut immunotherapy
Time Frame: 3 months
|
An unblinded evaluation of the safety of peanut immunotherapy as measured by the incidence of treatment-emergent adverse events (AEs and SAEs).
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean-Christoph Caubet, MD, University Hospitals of Geneva
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Actual)
April 19, 2022
Study Completion (Actual)
April 19, 2022
Study Registration Dates
First Submitted
July 16, 2021
First Submitted That Met QC Criteria
July 22, 2021
First Posted (Actual)
July 23, 2021
Study Record Updates
Last Update Posted (Actual)
August 28, 2023
Last Update Submitted That Met QC Criteria
August 24, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-02316
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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