Oral Immunotherapy for Peanut Allergy

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: Beta blockers

Disqualifiers: Severe asthma, Autoimmune conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

500 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how gradually eating small amounts of peanut can help people with peanut allergies reduce their allergic reactions. It focuses on individuals aged 6 months to 65 years and aims to improve their quality of life and predict who will benefit most from this treatment. A specific preparation of peanut allergen was approved for younger patients with a peanut allergy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using beta blocker medications.

What data supports the effectiveness of the treatment Peanut Oral Immunotherapy for peanut allergy?

Research shows that peanut oral immunotherapy can help desensitize people with peanut allergies, meaning they can tolerate more peanuts without having a severe reaction. However, it can also cause side effects like allergic reactions and stomach issues. ^{1 2 3 4 5}

Is peanut oral immunotherapy safe for humans?

Peanut oral immunotherapy can cause significant side effects, including serious allergic reactions and stomach issues, but it is being studied as a treatment option for peanut allergies. ^{1 3 6 7 8}

How is peanut oral immunotherapy different from other treatments for peanut allergy?

Peanut oral immunotherapy is unique because it involves gradually consuming small amounts of peanut to build up tolerance, unlike other treatments that focus on avoiding peanuts entirely. This approach aims to desensitize the immune system, but it can cause side effects like allergic reactions, which limits its widespread use. ^{1 2 3 4 6}

Research Team

Wayne G Shreffler, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for individuals aged 6 months to 65 years with a confirmed IgE-mediated peanut allergy, or those who have had a reaction to peanuts and show specific immune responses in tests. Participants must be referred by an MGH allergist and willing (or their caregivers) to consent. It's not for those with recent severe allergic reactions, uncontrolled asthma, certain chronic conditions, current beta blocker use, or pregnant/breastfeeding women.

Inclusion Criteria

I was referred by an MGH allergist for food allergy treatment.

I or my child have a confirmed peanut allergy through tests or history.

I am between 6 months and 65 years old with a peanut allergy.

Exclusion Criteria

Investigator determination of safety concern for any reason

I am currently taking beta blocker medication.

Inability to cooperate with and/or perform oral food challenge procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo food oral immunotherapy (OIT) for peanut allergy, gradually increasing peanut protein intake to desensitize the immune system

2 years

Regular visits for dose escalation and monitoring

Maintenance

Participants maintain a stable dose of 300 mg peanut protein to sustain desensitization

12 months

Periodic visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments and immunological tests

4 years

Annual visits for follow-up assessments

Treatment Details

Interventions

• Peanut Oral Immunotherapy

Trial Overview The study is testing the outcomes of peanut oral immunotherapy—a treatment where people with peanut allergies are given small amounts of peanut protein to build up tolerance. The process includes biomarker sampling and questionnaires from participants or caregivers.

Participant Groups

Group I: active peanut OIT Experimental Treatment 1 Intervention

active peanut oral immunotherapy

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Oral immunotherapy for peanut allergy (PACE): a systematic review and meta-analysis of efficacy and safety. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Community Private Practice Clinical Experience with Peanut Oral Immunotherapy. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Peanut gastrointestinal delivery oral immunotherapy in adolescents: Results of the build-up phase of a randomized, double-blind, placebo-controlled trial (PITA study). [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of AR101 in Oral Immunotherapy for Peanut Allergy: Results of ARC001, a Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Long-term outcome of peanut oral immunotherapy-Real-life experience. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of a peanut oral immunotherapy protocol in children with peanut allergy. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Oral Immunotherapy in Japanese Children with Anaphylactic Peanut Allergy. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Novel baseline predictors of adverse events during oral immunotherapy in children with peanut allergy. [2022]