Peanut Allergy MedDRA version: 20.1 Level: LLT Classification code 10034202 Term: Peanut allergy System Organ Class: 100000004870
Conditions
Sponsors
Aimmune Therapeutics , Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each subject eligible to participate in this study must meet all the following criteria: 1. Aged 1 to 3 mg to = 300 mg in a screening DBPCFC. 5. A palatable vehicle food to which the subject is not allergic must be available for administering study product. Are the trial subjects under 18? yes Number of subjects for this age range: 132 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: Each subject eligible to participate in this study must NOT meet any of the following exclusion criteria: 1. History of severe or life-threatening anaphylaxis. 2. History of hemodynamically significant cardiovascular or renovascular disease, including uncontrolled or inadequately controlled hypertension. 3. History of biopsy-confirmed diagnosis of EoE; other eosinophilic GI disease; chronic, recurrent, or severe gastroesophageal reflux disease (GERD); or symptoms of dysphagia (eg, difficulty swallowing, food “getting stuck”). 4. Recurrent GI symptoms considered clinically significant in the opinion of the investigator. 5. History of a mast cell disorder including mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (eg, cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema. 6. Moderate or severe persistent asthma (criteria steps 3-6; National Heart, Lung, and Blood Institute [NHLBI], 2007). 7. Mild asthma (criteria steps 1-2; NHLBI, 2007) that is uncontrolled or difficult to control based on NHLBI 2007 criteria. 8. History of high-dose corticosteroid use (eg, 1-2 mg/kg prednisone or equivalent for > 3 days) by any route of administration as defined by any of the following: • Steroid administered daily for > 1 month within 1 year before screening • One steroid course within 6 months before screening • More than 2 steroid courses = 1 week in duration within 1 year before screening 9. History of food protein-induced enterocolitis syndrome (FPIES) within 12 months before screening. 10. Recurrent urticaria. 11. History of failure to thrive or any other form of abnormal growth, or developmental or speech delay that precludes age-appropriate communication. 12. History of chronic disease (except mild intermittent asthma, mild persistent asthma that is controlled, atopic dermatitis, or allergic rhinitis) that is or is at significant risk of becoming unstable or requiring a change in a chronic therapeutic regimen. 13. Unable to discontinue antihistamines and other medications that could interfere with the assessment of an allergic reaction for 5 half-lives of the medication before the screening SPT, first day of dose escalation, and DBPCFCs. 14. Use or anticipated use of a prohibited medication (eg, beta blockers [oral], angiotensin converting enzyme inhibitors, angiotensin receptor blockers, calcium channel blockers, or tricyclic antidepressants), monoclonal antibody, or any other immunomodulatory therapy (including immunosuppressive medications). 15. Treatment with any form of immunotherapy for any food allergy anytime before screening. 16. Participation in another clinical trial within 30 days or 5 half-lives of the investigational product, whichever is longer, before screening. 17. Allergy to oat. 18. Hypersensitivity to epinephrine or any of the excipients in the epinephrine autoinjector. 19. Parent/caregiver unable or unwilling to use epinephrine auto-injectors. 20. Unable to follow the protocol requirements. 21. Any other condition (concurrent disease, infection, comorbidity, or psychiatric or psychological disorders) or reason that may interfere with the ability to participate in the study, cause undue risk, or complicate the interpretation of data, in the opinion of the investigator or medical monitor. 22. Resides at the same place as another subject in any AR101 interventional trial. 23. Lives in the same household and/or is a family member of a spo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of AR101 treatment in peanut-allergic subjects aged 1 to < 4 years, assessed by tolerability of specified single doses of at least 600 mg peanut protein in a double-blind, placebo-controlled food challenge (DBPCFC);Secondary Objective: • Safety and tolerability of study treatment • Efficacy of AR101, assessed by tolerability of other specified single doses of peanut protein in a DBPCFC • Maximum severity of allergy symptoms in a DBPCFC;Primary end point(s): The primary efficacy endpoint is the proportion of subjects treated with AR101 compared with placebo who tolerate an at least 1000 mg single dose of peanut protein with no more than mild allergy symptoms during the exit DBPCFC. The Farrington-Manning test will be used to test the null hypothesis that the difference in desensitization response rate is 0 at the two-sided 0.05 significance level. Desensitization response rates and associated 95% CIs will be presented for each treatment group using exact Clopper-Pearson CIs.;Timepoint(s) of evaluation of this end point: After approximately 12 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of subjects who tolerate an at least 600 mg single dose of peanut protein with no more than mild allergy symptoms during the exit DBPCFC. • Proportion of subjects who tolerate an at least 300 mg single dose of peanut protein with no more than mild allergy symptoms during the exit DBPCFC. • The maximum severity of allergy symptoms after consuming peanut protein during the exit DBPCFC.;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
France, Germany, Ireland, United Kingdom, United States
Contacts
Public ContactRegulatory Affairs
Aimmune Therapeutics UK Limited
Outcome results
None listed