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TerminatedNCT04974970Updated Aug 28, 2023

Pilot Study on Immunotherapy for the Treatment of Persistant Peanut Allergy

A Phase 1/2 interventional study of Peanut Immunotherapy in Food Allergy and Peanut Allergy, sponsored by University Hospital, Geneva. Terminated at 1 site in Switzerland. Open to participants aged 12 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-08-28.

Sponsored by University Hospital, Geneva · Phase 1/2, Interventional, and Treatment

Why this study was terminated
early termination due to insufficient recruitment

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Apr 2019, registered Jul 2021).
Phase
Phase 1/2
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
12 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Food Allergy
  • Peanut Allergy
03

In context

Food Hypersensitivity

344 studies on the registry are indexed under Food Hypersensitivity; 87 are open to participants now.

This study's enrollment of 12 is below the median of 60 across 215 interventional studies indexed under Food Hypersensitivity.

Browse Food Hypersensitivity studies →

Lead sponsor

University Hospital, Geneva is the lead sponsor of 378 studies on the registry; 69 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Informed Consent as documented by signature.
  2. Male or female subjects 12 to 45 years old at screening visit.
  3. 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

  4. 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

Exclusion Criteria:

  1. 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).
  2. Subjects with a history of systemic reaction to peanutskin prick test with commercial extract.
  3. Uncontrolled asthma (Forced expiratory volume at one second (FEV1) \<70% of predicted value), active eosinophilic oesophagitis or any condition deemed incompatible by the investigator.
  4. Known or suspected systemic mastocytosis.
  5. Subject currently under allergen immunotherapy.
  6. Subject/parent with excessive anxiety unlikely to cope with study conditions as per investigator's opinion.
  7. 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.
  8. Use of immunosuppression or immunomodulatory drug (including anti-IgE or anti-Tumor necrosis factor (TNF)) within 1 year prior to inclusion in study.
  9. Relative counter-indication or inability to use epinephrine auto-injector.
  10. Subjects receiving beta-blockers or angiotensin converting-enzyme (ACE) inhibitors.
  11. Women who are pregnant or breast feeding.
  12. 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).
  13. Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.).
  14. Diseases with a contraindication for the use of adrenalin (e.g. hyperthyroidism, glaucoma).
  15. Known or suspected non-compliance, drug or alcohol abuse.
  16. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
  17. Patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigators
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Peanut allergenic extract

    injected peanut extract.

    Drug: Peanut Immunotherapy

Interventions

  • DrugPeanut Immunotherapy

    Treatment will be injected peanut extract every 2 weeks for a period of 3 months.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

  3. 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).

    Time frame: 3 months

07

Study locations

1 site
  • Pediatric allergy unit, Hôpitaux Universitaires de Genève (HUG)
    Geneva, 1211, Switzerland
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2019 to primary completion in Apr 2022, 36 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 16, 2021
First posted
Jul 23, 2021
StartActual
Apr 1, 2019
Primary completionActual
Apr 19, 2022
CompletionActual
Apr 19, 2022
Last update
Aug 28, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04974970
Responsible party
Jean-Christoph Caubet (Principal investigator, University Hospital, Geneva) — Principal investigator
First posted
Jul 23, 2021
Start date
Apr 1, 2019
Primary completion
Apr 19, 2022
Completion
Apr 19, 2022
Last update
Aug 28, 2023

Study contacts

Jean-Christoph Caubet, MD
principal investigator · University Hospitals of Geneva

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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