Health TrialsbyHealthPanel

Oral Immunotherapy for Peanut Allergic Patients

ConditionPeanut Allergy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-65
SponsorInnoUp Farma S.L.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Placebo

    Drug

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: INP20 (Oral Immunotherapy)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Safety of the investigational product

Time frame
Week 4 and Week 25
2

Number of patients experiencing any dose limiting toxicity (DLT)

Tolerability of the investigational product

Time frame
Week 2

Secondary outcomes

1

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

Pharmacodynamics

Time frame
Week 4
2

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

Efficacy of the investigational product

Time frame
Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

InnoUp Farma S.L.

Lead sponsor

Source ClinicalTrials.gov
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