At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A One Month, Investigator and Participant Blinded Study to Investigate the Efficacy and Safety of Remibrutinib (LOU064) at Multiple Dose Levels in Adult Participants With Peanut Allergy
In Brief
A Phase 2 clinical trial evaluating LOU064 and placebo for Allergy, Peanut. Completed, enrolled 76 participants across 24 sites.
Signals
Detailed Summary
A study to evaluate the safety, efficacy and tolerability of remibrutinib at three doses versus placebo in adult participants who have a confirmed allergy to peanuts. The efficacy was measured by the ability of participants to tolerate increasing doses of peanut protein during an oral food challenge after 1 month of study treatment.
Study Details
Timeline
Arms & Interventions
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
LOU064 100 mg was administered orally twice per day, on Days 1 through 28.
Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.
Placebo was administered orally twice per day, on Days 1 through 28.
Interventions
oral tablets
oral tablets