Clinical trial NCT04222491: Food Oral Immunotherapy for Peanut Allergy
Official title: Outcomes of Clinical Food Oral Immunotherapy for Peanut Allergy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Peanut Allergy
Keywords: food allergy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open label observational single center study of clinical food oral immunotherapy outcomes with biomarker samples and participant and/or caregiver-completed questionnaires in participants between 6 months and 65 years of age with IgE-mediated peanut allergy undergoing food oral immunotherapy.
Primary purpose: TREATMENT

Brief summary: This is an open label observational single center study of clinical food oral immunotherapy outcomes with biomarker samples and participant and/or caregiver-completed questionnaires in participants between 6 months and 65 years of age with IgE-mediated peanut allergy undergoing food oral immunotherapy.

Detailed description: In this research study the investigators want to learn more about the experience of participants with peanut allergy and their caregivers undergoing food oral immunotherapy (OIT) for peanut allergy. Food oral immunotherapy (OIT) is a treatment for individuals with a food allergy to reduce the body's allergic response to the food allergen, resulting in fewer symptoms. The treatment is also called desensitization. An individual becomes desensitized to the food allergen by ingesting small amounts of the food that are slowly increased. Over time, this helps the body's immune system become used to the food so that it no longer causes an allergic reaction. By desensitizing to peanut, it may lower the risk of life-threatening allergic reactions and cause a decreased sensitivity to peanut. The investigators specifically want to learn more about the effects of food OIT on quality of life and other outcomes important to participants with peanut allergy and their caregivers and to ultimately develop tests to predict who may respond favorably to food OIT.

Eligibility criteria: Inclusion Criteria:

* Individuals between 6 months and 65 years of age with a diagnosis of immunoglobulin E (IgE)-mediated peanut allergy and their caregivers; a diagnosis of IgE-mediated peanut allergy is defined by: (1) documented history of peanut allergy or determined to be allergic by oral food challenge; (2) evidence of peanut-specific IgE by either: positive skin prick test to peanut allergen (reaction wheal at least 3 mm larger than saline control) or serum peanut-specific IgE \> 0.34 kilo-unit/liter (kU/L) or international unit/milliliter (IU/mL) at screening visit
* Referral by Massachusetts General Hospital (MGH) allergist for food oral immunotherapy
* Willing to sign informed consent or whose caregiver is willing to sign the informed consent (age appropriate)
* Willing to sign the assent form, if age appropriate

Exclusion Criteria:

* History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
* Severe or poorly controlled asthma
* Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions or gastrointestinal inflammatory conditions, such as inflammatory bowel diseases and eosinophilic gastrointestinal disorders
* Current use of beta blocker medication(s)
* Inability to cooperate with and/or perform oral food challenge procedures
* Females who are pregnant, planning to become pregnant, or breastfeeding
* Investigator determination of safety concern for any reason

Primary outcomes:
measure: The proportion of participants who tolerate the maintenance dose of 300 mg peanut protein with no symptoms within two years of starting OIT
timeFrame: 2 years
Secondary outcomes:
measure: Change in quality of life scores from baseline to end of treatment
timeFrame: 4 years
measure: Change in peanut specific serum immunoglobulin E (IgE) from baseline to end of treatment
timeFrame: 4 years
measure: Change in skin prick test reactivity to peanut extract from baseline to end of treatment
timeFrame: 4 years
measure: The proportion of participants who tolerate a cumulative dose of 5000 mg peanut protein on oral food challenge without treatment after 12 months on maintenance dose
timeFrame: 4 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 4 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Wayne G Shreffler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: