Oral Immunotherapy for Peanut Allergic Patients

NCT04163562 | Recruiting Phase 1 DMC

• 1 other identifier: INP20-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• Incidence rate, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs)

  Safety of the investigational product

  Week 4 and Week 25

• Number of patients experiencing any dose limiting toxicity (DLT)

  Tolerability of the investigational product

  Week 2

Secondary Outcomes (2)

• Change in Immunoglobulin G subtype (IgG4) and basophil activation on the BAT (basophil activation test).

  Week 4

• Differences in reaction thresholds (challenge test) to peanut of treatment groups versus the placebo after 6 months of INP20 treatment.

  Week 24

Study Arms (2)

INP20 (Oral Immunotherapy)

EXPERIMENTAL

Drug: INP20

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

INP20 DRUG

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.

INP20 (Oral Immunotherapy)

Placebo DRUG

Part A: Oral placebo administration onces daily for 2 weeks. Part B: Oral placebo administration onces daily for 6 months.

Placebo

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The presence of specific IgE to peanuts (a positive skin prick test to peanuts (diameter of wheal \> 3.0 mm) and a positive peanut IgEs \[CAP-FEIA\] \> 0.35 kUA/L.
• A history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts.
• Have a positive double-blind placebo-controlled food challenge (DBPCFC) to peanut at a cumulative dose of less than 10 grams of peanut protein.
• Provide signed informed consent for the participation in the study.
• Have self-injectable epinephrine available at home and be trained on its proper use.
• Potentially fertile women must agree to be sexually inactive or to use appropriate contraceptive measures for the duration of the study and for 1 month afterward.

You may not qualify if:

• History of severe anaphylaxis to peanut as defined by respiratory distress with cyanosis, hypoxemia (O2 Sat \<92%) or, in the absence of other clinical records, severe dyspnea; hypotension with or without loss of consciousness; or relaxation of sphincters.
• Currently participating in another study using an investigational new drug.
• Participation in any interventional study, specific oral or sublingual immunotherapy building up phase for the treatment of food allergy in the past 12 months.
• Allergic to placebo ingredients or reacts to any dose of placebo during study entry DBPCFC.
• Patients allergic to corn food.
• Poor control or persistent activation of severe atopic dermatitis.
• Moderate to severe persistent asthma.
• Prior intubation/mechanical ventilation for asthma.
• Currently being treated with greater than medium daily doses of inhaled corticosteroids (fluticasone \>500 μg per day, ciclesonide \>400 μg per day or budesonide \>800 μg per day) or montelukast.
• Chronic gastrointestinal diseases.
• Primary or secondary immunodeficiency.
• Have a severe reaction at initial DBPCFC (life-threatening anaphylaxis or reaction requiring hospitalization).
• Chronic use of beta blockers, angiotensin converting enzyme inhibitors, or monoamine oxidase inhibitors, proton pump inhibitors, H2-bloquers, prokinetic drugs and laxatives.
• Inability to discontinue antihistamines for 7 days before skin testing and oral food challenges (OFCs).
• Patients diagnosed with other serious food allergies defined as those who have required intubation and/or ICU admission.

Sponsors & Collaborators

• InnoUp Farma S.L.: lead

Study Sites (2)

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Complejo Hospittalario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Marta Ferrer, PhD, MD

  Clinica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

• Ana Tabar, PhD, MD

  Complejo Hospitalario de Navarra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maite Agüeros, PhD

CONTACT

+34 639151974; magueros@innoupfarma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 14, 2019
• Study Start: March 11, 2020
• Primary Completion: May 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

ES (2)