Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts
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.
Timeline
- Start
- 2022-10-12
- Primary completion
- 2025-03-11
- Completion
- 2025-03-11
Outcome
Met primary endpoint
registry LOU064 100 mg vs Placebo; Difference in Marginal Response Rate 0.77 (80% CI 0.61 to 0.90); Bayesian Analysis reads as unknown NCT05432388 ↗
registry LOU064 100 mg vs Placebo; Posterior Probability 1.000; Bayesian Analysis reads as unknown NCT05432388 ↗
release “A Phase II study with remibrutinib in food allergy met its primary endpoint with a statistically significant and clinically meaningful benefit.” reads as met primary endpoint novartis.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Remibrutinib | Small molecule | 10 mg | Oral |
| Subject | Remibrutinib | Small molecule | 25 mg | Oral |
| Subject | Remibrutinib | Small molecule | 100 mg | Oral |