Food AllergyPhase 1/2NCT04974970
Pilot Study on Immunotherapy for the Treatment of Persistant Peanut Allergy
A Phase 1/2 study testing Peanut Immunotherapy in people with Food Allergy and Peanut Allergy, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Food Allergy, Peanut Allergy
- What is being tested?
- Peanut Immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2019to 19 Apr 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Pediatric allergy unit, Hôpitaux Universitaires de Genève (HUG)
Geneva, 1211
About this study
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.
- Conditions
- Food Allergy, Peanut Allergy
- Being tested
- Peanut Immunotherapy
- Medical subject headings
- Food Hypersensitivity, Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut ImmunotherapyDrug
Treatment will be injected peanut extract every 2 weeks for a period of 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Peanut allergenic extract | Experimental | injected peanut extract. Receives: Drug: Peanut Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 3 months
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.
Measured: 3 months
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Apr 2019
- Primary completion19 Apr 2022
- Study completion19 Apr 2022
Why it stopped: early termination due to insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Christoph Caubet, University Hospital, Geneva
- Investigators
- Jean-Christoph Caubet, MD, Principal investigator, University Hospitals of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974970
- Sponsor's protocol ID
- 2018-02316
- Other IDs
- 2018
- Status last verified
- Aug 2023
- First submitted
- 16 Jul 2021
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Immunotherapy for the Treatment of Persistant Peanut Allergy
- ClinicalTrials.gov ID
- NCT04974970
- Acronym / sponsor ID
- 2018-02316
- Conditions
- Food Allergy, Peanut Allergy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: early termination due to insufficient recruitment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peanut allergenic extract | Experimental | Drug: Peanut Immunotherapyinjected peanut extract. |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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:
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peanut ImmunotherapyTreatment will be injected peanut extract every 2 weeks for a period of 3 months. | Drug | Peanut allergenic extract |
Primary outcome
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 secondary outcomes
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
Change in titrated skin prick test after 6 weeks and 3 months of treatment with peanut extract compared to baseline.
Time frame: 3 months
Incidence rate of treatment emergent adverse events during peanut immunotherapy
Time frame: 3 months
Results and safety
The study was stopped early (reason given: early termination due to insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Christoph Caubet, MD principal investigator
University Hospitals of Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Peanut Immunotherapy in people with Food Allergy and Peanut Allergy, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: early termination due to insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Result (positive or negative) and cumulative reaction threshold at 3 months peanut oral food challenge (OFC). (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.