PALISADE follow-on study
Research type
Research Study
Full title
PEANUT ALLERGY ORAL IMMUNOTHERAPY STUDY OF AR101 FOR DESENSITIZATION IN CHILDREN AND ADULTS (PALISADE) FOLLOW-ON STUDY
IRAS ID
226436
Contact name
George Du Toit
Contact email
Sponsor organisation
Aimmune Therapeutics Inc.
Eudract number
2016-004941-94
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 9 days
Research summary
This project (ARC004) is an extension to the previous ARC003 (PALISADE) study, which was an international, multi-centre, randomised study recruiting approximately 500 children and adults to receive either study drug (AR101) or placebo. ARC004 is a follow-on study with the objectives of: i) allowing placebo treated subjects from the PALISADE study to access study drug, ii) to prolong the treatment periods of AR101 to further establish a safety and efficacy profile, iii) explore alternative oral immunotherapy (OIT) desensitizing regimens. \n\nARC004 is an international, multi-centre, open label follow-on study. ARC004 will have two treatment groups, one of which will include those patients who had previously received placebo (placebo cross-overs); whereas the other group will be comprised of patients who received active treatment (active roll-overs) in PALISADE. \nThe objective of ARC004 study is to determine the safety, tolerability and efficacy of AR101 using alternative maintenance dosing intervals.\n
REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0236
Date of REC Opinion
23 May 2017
REC opinion
Favourable Opinion