Peanut allergy study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

-Age 4 through 55 years (inclusive)
-Clinical history of allergy to peanuts or peanut-containing foods
-Serum IgE to peanut of =0.35 kUA/L [determined by UniCAPTM within the past 12 months] and/or a SPT to peanut =3 mm compared to control
-Experience dose-limiting symptoms at or before the 100 mg challenge dose of peanut protein (measured as 200 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 adult subjects
-Written informed consent from parent/guardian for minor 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
-Not be residing at the same address as another subject in this or any peanut OIT study
Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- History of 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, 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
- 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, see Appendix 2)
- 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) < 80% of predicted, or ratio of FEV1 to forced vital capacity (FEV1/FVC) < 75% of predicted, with or without controller medications (only for age 6 or greater and able to do spirometry) or
- Inhaled corticosteroid (ICS) dosing of > 500 mcg daily fluticasone (or equivalent ICSs based on National Heart, Lung, and Blood Institute
[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 steroid medication use (via intravenous [IV], intramuscular [IM] or oral administration) in any of the following manners:
- history of daily oral steroid dosing for >1 month during the past year or
- burst oral steroid course in the past 3 months prior to randomization or
- >2 burst oral steroid 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 DBPCFC
- Lack of an available palatable vehicle food to which the subject is not allergic
- Use of omalizumab within the past 6 months prior to screening, or current use of other investigational forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids)
- Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
- Pregnancy or lactation
- Having the same place of residence as another subject in the study
- Participation in another clinical trial within 30 days or 5 half-lives of the investigational product, whichever is longer, prior to randomization
- Developing dose limiting symptoms in reaction to the placebo part of the Screening DBPCFC

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 peanutallergic<br>children and adults (ages 4-55 years, inclusive).;Secondary Objective: To demonstrate the safety of AR101 as measured by the incidence of adverse events, including serious adverse events. To evaluate the immunological effects of peanut OIT therapy.;Primary end point(s): The primary clinical efficacy endpoint is the proportion of subjects who<br>tolerate at least 1043 mg cumulative of peanut protein with no more<br>than mild symptoms at the Exit DBPCFC;Timepoint(s) of evaluation of this end point: After approximately 12 months treatment including 6 months at maintenance dose of 300mg/day

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - The proportion of subjects who tolerate at least 443 mg cumulative of peanut protein with no more than mild symptoms at the Exit DBPCFC<br>- The maximum severity of symptoms occurring at each challenge dose of peanut protein during the Exit DBPCFC<br>- 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: Not applicable