Peanut Allergy MedDRA version: 20.0 Level: PT Classification code 10016946 Term: Food allergy System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Product Code: AR101 (300 mg)
Pharmaceutical Form: Pouch
INN or Proposed INN: -
Current Sponsor code: AR101
Other descriptive name: Characterised Peanut Allergen
Concentration unit: mg milligram(s)
Con
Sponsors
Aimmune Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 4 to 17 years, inclusive, at screening 2. Written informed consent from subjects, as appropriate per local requirements, and legal guardian/parent (or both parents where required by local authorities) of subjects who are minors. 3. Written assent from subjects who are minors, as appropriate per local requirements 4. Written informed consent from the parent/caregiver who will complete relevant questionnaires during the study 5. History of physician-diagnosed immunoglobulin (Ig) E-mediated peanut allergy that includes the onset of characteristic signs and symptoms of allergy within 2 hours of known oral exposure to peanut or peanut-containing food. In general, characteristic signs and symptoms of IgE-mediated allergic reactions are objective and affect the target organs of skin, gastrointestinal (GI) tract, upper/lower respiratory tract, cardiovascular system, or a combination of target organs 6. Mean wheal diameter on SPT to peanut = 8 mm greater than the negative saline control at screening 7. Serum IgE to peanut of = 14 kUA/L at screening 8. For sexually active females of childbearing potential, use of a highly effective method of birth control, defined as one that results in a low failure rate (ie, =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Uncertain clinical diagnosis of peanut allergy 2. History of severe or life-threatening anaphylaxis or anaphylactic shock within 60 days before screening 3. 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 any etiology 4. History of a mast cell disorder including systemic mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (eg, cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema 5. Severe persistent asthma 6. Mild or moderate asthma (criteria steps 1-4; NHLBI, 2007) that is uncontrolled or difficult to control 7. History of high-dose corticosteroid medication use (eg, > 3 days at 1-2 mg/kg of prednisone or equivalent) 8. History of chronic disease (except asthma, atopic dermatitis, or allergic rhinitis) that is or is at significant risk of becoming unstable or requiring a change in a chronic therapeutic regimen, including malignancies within 5 years before screening and autoimmune diseases 9. History of cardiovascular disease including uncontrolled or inadequately controlled hypertension 10. Use of beta-blockers (oral), angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, calcium channel blockers, or tricyclic antidepressants 11. Unable to discontinue antihistamines 5 half-lives of the medication before the SPT, first day of dose escalation, and food challenges 12. Lack of an available palatable vehicle food to which the subject is not allergic 13. Allergy to oat 14. Use of any therapeutic antibody or any immunomodulatory therapy (including immunosuppressive medications) except aeroallergen or venom immunotherapy used in the maintenance phase within 6 months before screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess proxy- and self- reported disease-specific HRQOL of peanut-allergic subjects aged 4 to 17 years, inclusive, receiving AR101 in combination with standard of care versus standard of care alone for approximately 18 months. ;Secondary Objective: - Safety and tolerability of AR101 To characterize changes over the course of the study in the following: - Disease-specific HRQOL of parents/caregivers - Relationship between clinical efficacy of AR101 (change in level of sensitization to peanut allergen) and HRQOL of subjects and parents/caregivers ;Primary end point(s): To assess proxy- and self-reported disease-specific HRQOL of peanut-allergic subjects aged 4 to 17 years, inclusive, receiving AR101 in combination with standard of care versus standard of care alone for approximately 18 months ;Timepoint(s) of evaluation of this end point: Questionnaires are completed before randomization and approximately every 3 months thereafter. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: N/A;Secondary end point(s): -Safety and tolerability of AR101 To characterize changes over the course of the study in the following: -Disease-specific HRQOL of parents/caregivers -Relationship between clinical efficacy of AR101 (change in level of sensitization to peanut allergen) and HRQOL of subjects and parents/caregivers | — |
Countries
Germany, Ireland, Netherlands, Spain, Sweden
Contacts
Public ContactRegulatory Affairs
Aimmune Therapeutics UK Ltd
Outcome results
None listed