Peanut Allergy
Conditions
Sponsors
Aimmune Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 4 through 17 years (inclusive) Clinical history of allergy to peanuts or peanut-containing foods Serum IgE to peanut = 0.35 kUA/L, inclusive (as determined by UniCAP™ within the past 12 months) and/or a peanut SPT wheal diameter = 3 mm compared to control Experience dose-limiting symptoms at or before the 300 mg (444 mg cumulative) challenge dose of peanut protein (measured as 600 mg of peanut flour) on Screening DBPCFC conducted in accordance with PRACTALL (Practical Issues in Allergology, Joint United States/European Union Initiative) guidelines Written informed consent from subject or parent/guardian for all subjects Written assent from minor subjects as appropriate (e.g., above the age of 7 years or the applicable age per local regulatory requirements) Use of effective birth control by female subjects of child-bearing potential Are the trial subjects under 18? yes Number of subjects for this age range: 160 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: History of hemodynamically significant cardiovascular disease, including uncontrolled or inadequately controlled hypertension History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of Screening DBPCFC History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of, becoming unstable or requiring a change in chronic therapeutic regimen History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia (e.g., difficulty swallowing, food “getting stuck”), or recurrent gastrointestinal symptoms of undiagnosed etiology Current participation in any other interventional study and/or participation in another interventional clinical study within 30 days or 5 half-lives of the investigational product, whichever is longer, prior to randomization Participation in, and having received active treatment in, any previous clinical study of AR101 CODIT™ Participation in any peanut immunotherapy clinical study (including oral, sublingual, or epicutaneous) within 6 months prior to Screening Subject is in “build-up phase” of immunotherapy to another allergen (i.e., has not reached maintenance dosing) Severe asthma (2007 NHLBI Criteria Steps 5 or 6) Mild or moderate asthma (2007 NHLBI Criteria Steps 1-4), if uncontrolled or difficult to control as defined by any of the following: - Forced expiratory volume in 1 second (FEV1) 500 mcg daily fluticasone (or equivalent ICS based on NHLBI dosing chart); or - 1 hospitalization in the past year prior to Screening for asthma; or - Emergency room (ER) visit for asthma within 6 months prior to Screening History of high-dose corticosteroid use (e.g., 1 to 2 mg/kg of prednisone or the equivalent for > 3 days) by any route of administration in any of the following manners: - history of daily corticosteroid dosing for > 1 month during the past year; or - 1 corticosteroid course in the past 3 months; or - > 2 corticosteroid courses in the past year = 1 week in duration Inability to discontinue antihistamines 5 half-lives before the initial day of escalation, skin prick testing, or Screening DBPCFC Lack of an available palatable vehicle food to which the subject is not allergic Use of any therapeutic antibody (e.g., omalizumab, mepolizumab, reslizumab, etc.) or any other immunomodulatory therapy excluding aeroallergen, venom immunotherapy, or corticosteroids within the past 6 months Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB), calcium channel blockers, or tricyclic antidepressants Pregnancy or lactation Residing at the same address as another subject in this or any peanut OIT study Developing dose limiting symptoms in reaction to the placebo part of the Screenin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate the efficacy of AR101, a pharmaceutical-grade peanut allergen formulation, through reduction in clinical reactivity to limited amounts of peanut allergen in peanut-allergic children and adolescents (ages 4 to 17 years, inclusive).;Secondary Objective: The secondary objectives are to demonstrate the safety of AR101 as measured by the incidence of adverse events (AEs), including serious adverse events (SAEs) and to evaluate the immunological effects of peanut OIT therapy.;Primary end point(s): The primary clinical efficacy endpoint is the proportion of subjects who tolerate at least 2043 mg cumulative of peanut protein with no more than mild symptoms at the Exit DBPCFC.;Timepoint(s) of evaluation of this end point: After approximately 56 weeks of treatment including up to 16 weeks at maintenance dose of 300mg/day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The proportion of subjects who tolerate at least 1043 mg cumulative of peanut protein with no more than mild symptoms at the Exit DBPCFC • The proportion of subjects who tolerate at least 443 mg cumulative of peanut protein with no more than mild symptoms at the Exit DBPCFC • The maximum severity of symptoms occurring following ingestion of peanut protein during the Exit DBPCFC ;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
France, Germany, Ireland, Italy, Spain, Sweden, United Kingdom
Contacts
Public ContactRegulatory Affairs
Aimmune Therapeutics UK Ltd
Outcome results
None listed