Peanut Allergy
Conditions
Interventions
Trade Name: Palforzia
Product Name: AR101
Pharmaceutical Form: Oral powder in sachet
Pharmaceutical form of the placebo: Oral powder in sachet
Route of administration of the placebo: Oral use
Sponsors
Aimmune Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Completion of study ARC001 • Written informed consent from subject and/or parent/guardian • Written assent from all subjects as appropriate • Use of birth control for females of child-bearing potential • No change in the status of any longitudinally applicable ARC001 inclusion criteria Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Early termination from ARC001 • For former active AR101 (CPNA) treatment subjects from ARC001 (Group 2), failure to tolerate with no or mild symptoms 300 mg of peanut protein in their ARC001 exit DBPCFC • Pregnancy or lactation • For former placebo subjects from ARC001 (Group 1), a lapse in dosing of more than 10 days from completion of ARC001 • Change in the status of any longitudinally applicable ARC001 exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the safety and tolerability of AR101 [Characterized Peanut Allergen (CPNA)] when used in an oral immunotherapy (OIT) paradigm over an extended period (= 18 months) in peanut-allergic children and young adults who initiated OIT between the ages of 4 to 26 years, inclusive.;Secondary Objective: • To confirm and extend prior observations from ARC001 on the efficacy of Characterized Peanut Allergen in OIT, as assessed through reduction in clinical reactivity to limited amounts of peanut allergen. • To evaluate the immunological effects of peanut OIT • To determine the time course of tolerated up-dosing • To evaluate safety based on physician global assessment of disease activity The exploratory objective is to assess a higher degree of desensitization, based on an Open-label Food Challenge (OFC) up to a cumulative dose of 4043 mg of total peanut protein.;Primary end point(s): The primary end-point is the incidence of treatment-related adverse events and dosing symptoms occurring with peanut OIT over a protracted treatment period comprising at least 18 months.;Timepoint(s) of evaluation of this end point: After approximately 18 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The proportion of subjects who tolerate at least 300 mg (443 mg cumulative) of peanut protein with no more than mild symptoms during DBPCFC • The proportion of subjects who tolerate at least 600 mg (1043 mg cumulative) of peanut protein with no more than mild symptoms during DBPCFC • The proportion of subjects who tolerate 1000 mg (2043 mg cumulative) of peanut protein with no more than mild symptoms during DBPCFC • Change from baseline (carried over from ARC001) in maximum dose of peanut protein tolerated with no, or only mild, symptoms during DBPCFC • Maximum dose of peanut protein tolerated with no, or only mild, symptoms during DBPCFC • Changes in peanut-specific immunoglobulin E (IgE) and immunoglobulin G4 (IgG4), changes in skin prick test (SPT) mean wheal diameters will also be assessed. • Physician global assessment: Disease activity as measured on a 100 mm visual analogue scale (VAS);Timepoint(s) of evaluation of this end point: NA | — |
Countries
United States
Contacts
Public ContactRegulatory Affairs
Aimmune Therapeutics UK Limited
Outcome results
None listed