peanut allergy
Conditions
Interventions
The investigational product is AR101.
Doses are expressed as mg of peanut protein. For the Initial Escalation and
Up-dosing periods, AR101 will be provided in pull-apart capsules at doses of
0.5, 1
Immunotherapy
Peanut allergy
Sponsors
Aimmune Therapeutics UK Limited
Eligibility
Age
2 Years to 64 Years
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
Exclusion criteria
Exclusion criteria: 1. Early discontinuation from ARC003 2. Meets any longitudinally applicable ARC003 exclusion criteria 3. (Group 2 only) Failure to tolerate *443 mg cumulative of peanut protein with no or mild symptoms in the ARC Exit DBPCFC 4. Any other condition that, in the opinion of the investigator, precludes participation for reasons of safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the frequency of treatment-related AEs, including SAEs, during the overall study period (from enrollment to the end of EM period). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 GI AEs of interest (GI AEIs) * Frequency of accidental food allergen exposure * In subjects with asthma, change in asthma control using the Asthma Control Test questionnaire (Appendix 2) * 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 * Changes in peanut skin prick test (SPT) wheal diameter *Baseline is defined as the Screening DBPCFC from ARC003 for both treatment groups. **Post-Maintenance is defined as the ARC003 Exit DBPCFCs for Group 2. | — |
Countries
The Netherlands
Outcome results
None listed