Trial Outcomes & Findings for Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents (NCT NCT03703791)

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1 participants

Primary outcome timeframe

18 months per subject, approximately 30 months for the study

Results posted on

2021-07-13

Participant Flow

Three subjects were screened, 1 subject was randomly assigned to standard of care alone.

Participant milestones

Participant milestones
Measure	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	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.
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	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	Group 2 (Standard of Care Treatment) n=1 Participants 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.	Total n=1 Participants Total of all reporting groups
Age, Customized 14 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome data not reported

Adverse Events

Group 1 (AR101 Treatment + Standard of Care)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2 (Standard of Care Treatment)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Regulatory Affairs

Aimmune Therapeutics, Inc.

Phone: 650-409-5164

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee * Institutions cannot publish until the multi-center sponsor publication is published * Or, institutions cannot publish until 18 months after study completion * And Sponsor review of any publications is required prior to any institution publications according to contractual agreements
Publication restrictions are in place

Restriction type: OTHER