Peanut Allergy
Conditions
Sponsors
Aimmune Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Completion of ARC003 2. Written informed consent and/or assent from subjects/guardians as appropriate 3. 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: 400 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Early discontinuation from ARC003 2. Meets any longitudinally applicable ARC003 exclusion criteria 3. Failure to tolerate =443 mg cumulative of peanut protein with no or mild symptoms in the ARC003 Exit DBPCFC (Group 2 only) 4. Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the safety, tolerability and efficacy of AR101 characterized oral desensitization immunotherapy using alternative maintenance dosing intervals.; Secondary Objective: The secondary objectives are: • To confirm the safety profile of AR101 as measured by the incidence of adverse events (AEs), including serious adverse events (SAEs) • To confirm the efficacy of AR101 through reduction in clinical reactivity, measured in a double-blind, placebo-controlled food challenge (DBPCFC) to a cumulative dose of 4043 mg • To evaluate subjects’ quality of life (QoL) and treatment satisfaction during AR101 treatment on daily and non-daily treatment regimens • To evaluate the long-term immunologic effects of AR101 treatment ;Primary end point(s): The primary end-point is the frequency of treatment-related adverse events, including serious adverse events, during the overall study period (from enrollment to the end of Extended Maintenance).;Timepoint(s) of evaluation of this end point: The overall study period (from enrollment to the end of the Extended Maintenance period). | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: N/A; Secondary end point(s): Secondary endpoints include: • Frequency of anaphylaxis • Frequency of use of epinephrine as a rescue medication • Frequency of AEs leading to withdrawal of AR101 • Frequency of AEs in each treatment regimen leading to discontinuation of extended interval dosing • Frequency of gastrointestinal adverse events of interest (GI AEIs) • Frequency of accidental food allergen exposure • In subjects with asthma, change in asthma control using the Asthma Control Test questionnaire • Frequency of all above safety endpoints by treatment period • The proportion of subjects in each regimen tolerating = 1043 mg cumulative of peanut protein during their EM Exit DBPCFC • The proportion of subjects in each regimen who tolerate = 443 mg cumulative of peanut protein during their EM Exit DBPCFC • The proportion of subjects in each regimen who tolerate 4043 mg cumulative of peanut protein during their EM Exit DBPCFC • Maximum tolerated dose and change from baseline at Post-Maintenance and each EM Exit DBPCFC • Maximum severity of symptoms at each challenge dose at Post-Maintenance and each EM Exit DBPCFC • Frequency of use of epinephrine as a rescue medication at the Post-Maintenance and each EM Exit DBPCFC • Change in QoL as assessed by the food allergy related quality of life questionnaire (FAQLQ) and the food allergy independent measure (FAIM) questionnaire • Satisfaction with AR101 treatment as assessed by the Treatment Satisfaction Questionnaire for Medication Version 9 (TSMQ-9) questionnaire and additional questions • Changes in peanut-specific serum IgE and IgG4 levels | — |
Countries
Canada, Germany, Ireland, Netherlands, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactRegulatory Affairs
Aimmune Therapeutics UK Ltd
Outcome results
None listed