NCT04163562

Oral Immunotherapy for Peanut Allergic Patients

A Multicenter Double-blind, Randomized, Placebocontrolled Phase I/II Study to Determine the Safety, Tolerability, Potential Efficacy and Dose Finding of INP20, an Oral Formulation for Treatment of Immunotherapy in Peanut-allergic Patients

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: InnoUp Farma S.L. · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, double-blind, randomized, placebo-controlled phase I/II study to determine the safety, tolerability, potential efficacy and dose finding of INP20, an oral immunotherapy in peanut-allergic patients. The overall study design consists of two sequential periods of Part A and Part B. Part A is a dose escalation study in patients from 12 to 65 years old with a history of immediate hypersensitive reaction to peanut protein. Six diferent oral-dose of INP20 will be administered to 6 cohorts of patients once daily for 2 weeks. Part B is a 6-month double-blind, placebo-controlled, randomized and parallel groups study. Patients will be randomized in a 1:1:1 ratio into three (3) different treatment groups, including placebo and the two doses of peanut protein selected from Part A. They will recieve INP20 once daily for 6 months.

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
DRUG	INP20	Part A: Oral INP20 administration at ascending doses once daily for 2 weeks. Part B: Two doses of oral INP20 derived from Part A once daily for 6 months.
DRUG	Placebo	Part A: Oral placebo administration onces daily for 2 weeks. Part B: Oral placebo administration onces daily for 6 months.

Timeline

• Start date: 2020-03-11
• Primary completion: 2025-05-01
• Completion: 2025-09-01
• First posted: 2019-11-14
• Last updated: 2025-04-30

Locations

2 sites across 1 country: Spain