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Oral Immunotherapy for Peanut Allergic Patients

NCT04163562 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • InnoUp Farma S.L.

    lead INDUSTRY

Principal Investigators

  • Marta Ferrer, PhD, MD · Clinica Universidad de Navarra

  • Ana Tabar, PhD, MD · Complejo Hospitalario de Navarra

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-11
Primary Completion
2025-05-31
Completion
2025-09-30

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04163562 on ClinicalTrials.gov