Pilot Study on Immunotherapy for the Treatment of Persistant Peanut Allergy

NCT04974970 | Terminated Phase 1 DMC

• 1 other identifier: 2018-02316
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy; Peanut Allergy

Outcome Measures

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.

  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.

  3 months

• Change in titrated skin prick test 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

  3 months

Study Arms (1)

Peanut allergenic extract

EXPERIMENTAL

injected peanut extract.

Drug: Peanut Immunotherapy

Interventions

Peanut Immunotherapy DRUG

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

Peanut allergenic extract

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Pediatric allergy unit, Hôpitaux Universitaires de Genève (HUG)

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Food Hypersensitivity; Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity

Study Officials

• Jean-Christoph Caubet, MD

  University Hospitals of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 23, 2021
• Study Start: April 1, 2019
• Primary Completion: April 19, 2022
• Study Completion: April 19, 2022
• Last Updated: August 28, 2023

Record last verified: 2023-08

Locations

CH (1)