Peanut Allergy
Conditions
Keywords
AR101, Characterized Peanut Allergen (CPNA), (Characterized Peanut Allergen) OIT, Peanut Allergy, Allergy, Peanut-Allergic Children, Peanut-Allergic Adolescents, Desensitization, Quality of Life, OIT (oral immunotherapy), CODIT (TM) Characterized Oral Desensitization Immunotherapy (TM)
Brief summary
To compare the HRQOL of AR101 characterized oral desensitization immunotherapy (CODIT™) in combination with standard of care (peanut avoidance, education) versus standard of care alone in peanut-allergic subjects aged 4 to 17 years.
Detailed description
This is a phase 3b, randomized, open label, European study of the HRQOL of AR101 in combination with standard of care compared with standard of care alone in approximately 200 peanut-allergic subjects aged 4 to 17 years, inclusive.
Interventions
BIOLOGICALAR101
AR101 powder
Sponsors
Aimmune Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Age 4 through 17 years * History of physician diagnosed IgE mediated peanut allergy with characteristic signs and symptoms * Positive SPT for peanut * Positive serum IgE to peanut * Written informed consent from the subject's parent/guardian * Written assent from the subject as appropriate * Use of effective birth control by sexually active female subjects of childbearing potential Key
Exclusion criteria
* Uncertain clinical diagnosis of peanut allergy * History of severe or life threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening * Severe persistent asthma or uncontrolled mild or moderate asthma * History of eosinophilic esophagitis, other eosinophilic gastrointestinal disease, severe gastroesophageal reflux disease, symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology * History of a mast cell disorder, including mastocytosis, urticarial pigmentosa, and hereditary or idiopathic angioedema * History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension * History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of becoming, unstable or requiring a change in chronic therapeutic regimen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life | 18 months per subject, approximately 30 months for the study | The primary analyses will use scores from a family of proxy- and self-reported disease-specific HRQOL measures to assess the HRQOL of peanut-allergic subjects treated with AR101 or standard of care alone during the study. The relevant disease-specific HRQOL questionnaires include the FAQLQ-PF (parent form), FAQLQ-PFT (parent form teenager), FAQLQ-CF (child form), FAQLQ-TF (teenager form), FAIM-PF (parent form), FAIM-PFT (parent form teenager), FAIM-CF (child form), and FAIM-TF (teenager form). |
Countries
Spain
Participant flow
Recruitment details
Three subjects were screened, 1 subject was randomly assigned to standard of care alone.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 (AR101 Treatment + Standard of Care) Subjects receiving AR101 treatment will have 3 consecutive AR101 dosing periods before exiting (completing) the study: initial dose escalation, up dosing, and maintenance, with an OLFC (open label food challenge) approximately 12 months after randomization.
AR101: AR101 powder | 0 |
| Group 2 (Standard of Care Treatment) Subjects receiving standard of care alone will have approximately 18 months of observation before study exit, with an OLFC (open label food challenge) approximately 12 months after randomization. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Group 1 (AR101 Treatment + Standard of Care) | Group 2 (Standard of Care Treatment) | Total |
|---|---|---|---|
| Age, Customized 14 years | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Health-related Quality of Life
The primary analyses will use scores from a family of proxy- and self-reported disease-specific HRQOL measures to assess the HRQOL of peanut-allergic subjects treated with AR101 or standard of care alone during the study. The relevant disease-specific HRQOL questionnaires include the FAQLQ-PF (parent form), FAQLQ-PFT (parent form teenager), FAQLQ-CF (child form), FAQLQ-TF (teenager form), FAIM-PF (parent form), FAIM-PFT (parent form teenager), FAIM-CF (child form), and FAIM-TF (teenager form).
Time frame: 18 months per subject, approximately 30 months for the study
Population: No HRQOL, efficacy, or safety measurements were collected due to the sponsor's decision to terminate the study early.