RAMSES: A clinical trial for peanut allergy assessing safety1

RAMSES was a phase 3, multicenter, double-blind, placebo-controlled randomized study1

  • Designed to gain experience with PALFORZIA in a real-world setting, without requirement of a DBPCFC for study entry
  • All participants were monitored for adverse events through the approximate 6-month study duration1
Participants were NOT required to complete a DBPCFC for study entry.RAMSES trial design: 506 participants aged 4 through 17 years; highly peanut sensitive; of the intent-to treat population, 337 participants randomized to PALFORZIA,168 participants randomized to placeboRAMSES trial design: 506 participants aged 4 through 17 years; highly peanut sensitive; of the intent-to treat population, 337 participants randomized to PALFORZIA,168 participants randomized to placebo

Highly peanut-sensitive participants1

  • Clinical history of peanut allergy, including onset of symptoms within 2 hours of known oral peanut exposure
  • psIgE of ≥14 kUA/L
  • Mean wheal diameter on skin-prick test ≥8 mm greater than negative control
Primary endpoint2

Frequency of treatment-emergent adverse events, including serious adverse events, during the overall study period

DBPCFC = double-blind, placebo-controlled food challenge; psIgE = peanut-specific immunoglobulin E; RAMSES = Real-World AR101 Market Supporting Experience Study.

PALFORZIA had consistent safety results across both studies.

See Results

References

  1. PALFORZIA [package insert]. Brisbane, CA: Aimmune Therapeutics, Inc
  2. ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT03126227. NLM identifier: NCT03126227. February 26, 2018. Accessed September 14, 2020.