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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000326-58 | EudraCT Number |
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Sponsor terminated study; no impact on overall benefit risk evaluation of AR101
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (AR101 Treatment + standard of care) | Active Comparator | Subjects receiving AR101 treatment will have 3 consecutive AR101 dosing periods before exiting (completing) the study: initial dose escalation, up dosing, and maintenance. |
|
| Group 2 (Standard of Care Treatment) | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR101 | Biological | AR101 powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 18 months per subject, approximately 30 months for the study |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Director of Regulatory Affairs | Aimmune Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Germans Trias i Pujol | Badalona | Barcelona | 8916 | Spain | ||
| Corporacio Sanitaria Parc Tauli |
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Three subjects were screened, 1 subject was randomly assigned to standard of care alone.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study was terminated early based on the sponsor's conclusion that HRQOL data relevant to peanut allergy could be generated by alternative means.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | No HRQOL, efficacy, or safety measurements were collected due to the sponsor's decision to terminate the study early. | Posted | 18 months per subject, approximately 30 months for the study |
|
No HRQOL, efficacy, or safety assessments were performed due to the sponsor's decision to terminate the study early.
No HRQOL, efficacy, or safety assessments were performed due to the sponsor's decision to terminate the study early.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. AR101: AR101 powder |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Regulatory Affairs | Aimmune Therapeutics, Inc. | 650-409-5164 | RegulatoryAffairs@aimmune.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2018 | Jun 21, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
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| Sabadell |
| Barcelona |
| 8208 |
| Spain |
| Hospital Universitario Severo Ochoa | Leganés | Madrid | 28911 | Spain |
| Hospital Universitario Vall d'Hebron - PPDS | Barcelona | 8035 | Spain |
| Hospital Infantil Universitario Niño Jesus | Madrid | 28009 | Spain |
| Hospital Universitario Infanta Leonor | Madrid | 28032 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Complejo Hospitalario de Navarra | Pamplona | 31008 | Spain |
| Hospital Universitario de Canarias | Santa Cruz de Tenerife | 38320 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | 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. |
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |