Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03345160 |
Other study ID # |
IRB00150453 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
April 27, 2018 |
Est. completion date |
October 7, 2020 |
Study information
Verified date |
October 2021 |
Source |
Johns Hopkins University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This application is being submitted as a follow-up to Protocol "Oral Immunotherapy for
Induction of Tolerance in Peanut Allergic Children-The IMPACT Study." The IMPACT study was a
double-blind, placebo-controlled study of peanut oral immunotherapy in children 12-48 months
of age. As part this protocol, all participants who received placebo treatment were promised
the opportunity to receive open label treatment at the conclusion of the double-blind phase
and initial follow-up. At the time of submitting that protocol, the investigator did not
specify any detailed protocol for the open label crossover treatment, as this is an evolving
field, but the investigator is now ready to offer this open label treatment as promised.
Description:
This study will enroll up to 20 subjects aged 4-9 years old who were enrolled in the placebo
arm of the IMPACT study.
Once subjects have completed participation in the IMPACT study, subjects will be offered the
option of participating in this open label, peanut oral immunotherapy study.
After the informed consent has been signed, subjects will undergo an initial dose escalation
to peanut protein to establish the starting dose for the build-up phase. The starting dose of
peanut protein for the build-up phase will be the highest tolerated dose during the initial
dose escalation. The subject will return to the study site and the first starting dose of
peanut protein will be given under observation. Subjects will be sent home with doses of
peanut protein to administer at home.
Subject will return every 2 weeks for dose adjustments. Once subjects have tolerated a dose
under observation, subjects will then continue dosing at home with OIT and return to the
research unit every 2 weeks for a 1-step dose escalation to a maximum daily dose of 1000 mg.
Participants who do not reach the 1000mg dose by 40-weeks of build-up phase may enter the
maintenance phase at their highest tolerated dose.
When subjects reach their maximum tolerated dose of either 1000 mg per day, or the maximum
tolerated dose during the 40 weeks of the build-up phase, subjects will enter the maintenance
phase. Subjects will continue daily dosing of peanut protein at the maximum tolerated dose
during the 12-week maintenance phase.
At the end of the maintenance phase, subjects will undergo an open peanut oral food challenge
to a maximum of 4000 mg of peanut protein to determine individualized guidelines for the
introduction of peanut into the subject's diet based on the outcome of the open peanut
challenge The primary objective of this protocol is to provide open label peanut oral
immunotherapy (OIT) for those subjects who received placebo treatment in the IMPACT Study .
Secondary objectives will include:
1. Efficacy of the treatment, as defined by an end of treatment oral peanut challenge.
Safety, as measured by the incidence of adverse events and the proportion of subjects who
discontinue treatment due to adverse events