PEANUT ALLERGY STUDY
- Conditions
- Peanut AllergyTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2016-005004-26-GB
- Lead Sponsor
- Aimmune Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 160
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
• History of hemodynamically significant cardiovascular disease, including uncontrolled or inadequately controlled hypertension (Section 5.10)
• 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 including autoimmune diseases and malignancies (including malignancies occurring in the 5 years prior to Screening)
• History of eosinophilic esophagitis (EoE), other eosinophilic GI disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia (eg, difficulty swallowing, food getting stuck”), or recurrent GI 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 IP, whichever is longer, prior to randomization
• Participation in, and having received active treatment in, any previous clinical study of AR101 CODIT™
• Currently receiving, or having received in the 5 years prior to Screening, any type of peanut or any other food immunotherapy (including subcutaneous, sublingual, oral, or epicutaneous)
• Subject is in build-up phase” of immunotherapy to another allergen (ie, has not reached maintenance dosing)
• Severe asthma (2007 NHLBI Criteria Steps 5 or 6, 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:
o Forced expiratory volume in 1 second (FEV1) < 80% of predicted, with or without controller medications (only for age 6 years or greater and able to do spirometry); or
o Inhaled corticosteroid (ICS) dosing of > 500 mcg daily fluticasone (or equivalent ICS based on NHLBI dosing chart); or
o 1 hospitalization in the past year prior to Screening for asthma; or
o Emergency room (ER) visit for asthma within 6 months prior to Screening
• History of high-dose corticosteroid use (eg, 1 to 2 mg/kg of prednisone or the equivalent for > 3 days) by any route of administration in any of the following manners:
o history of daily corticosteroid dosing for > 1 month during the past year; or
o 1 corticosteroid course in the past 3 months; or
o > 2 corticosteroid courses in the past year = 1 week in duration
• Inability to discontinue antihistamines 5 half-lives before the initial day of escalation, SPT, or Screening DBPCFC
• Lack of an available palatable vehicle food to which the subject is not allergic
• Use of any therapeutic antibody (eg, omalizumab, mepolizumab, reslizumab, dupilumab, etc.) or any other immunomodulatory therapy excluding aeroallergen or venom immunotherapy, or corticosteroids within the past 6 months (Section 5.10)
• Use of beta blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB), calcium channel blockers, or tricyclic antidepressants (Section 5.10)
• Pregnancy or lactation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;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.
- Secondary Outcome Measures
Name Time Method