Pilot Study on Immunotherapy for the Treatment of Persistant Peanut Allergy

NCT ID: NCT04974970

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2022-04-19

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peanut allergenic extract

injected peanut extract.

Group Type: EXPERIMENTAL

Peanut Immunotherapy

Intervention Type: DRUG

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

Interventions

Peanut Immunotherapy

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

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Jean-Christoph Caubet

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-Christoph Caubet, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals of Geneva

Locations

Pediatric allergy unit, Hôpitaux Universitaires de Genève (HUG)

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

2018-02316

Identifier Type: -

Identifier Source: org_study_id