FARE - Food Allergy Research & Education Logo

Oral Immunotherapy for Peanut Allergic Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 12 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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.
  • - Women of childbearing potential (unless they are using highly effective methods of contraception during dosing and for at least 1 month after stopping medication), who are pregnant, planning to become pregnant, or breastfeeding.
  • - Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study may also exclude a participant from the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

InnoUp Farma S.L.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Marta Ferrer, PhD, MDAna Tabar, PhD, MD
Principal Investigator Affiliation Clinica Universidad de NavarraComplejo Hospitalario de Navarra
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Spain

The disease, disorder, syndrome, illness, or injury that is being studied.

Peanut Allergy
Arms & Interventions


Experimental: INP20 (Oral Immunotherapy)

Placebo Comparator: Placebo


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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Clinica Universidad de Navarra, Pamplona, Navarra, Spain




Clinica Universidad de Navarra

Pamplona, Navarra, 31008

Site Contact

Marta Ferrer, PhD, MD


+34 639151974

Complejo Hospittalario de Navarra, Pamplona, Navarra, Spain




Complejo Hospittalario de Navarra

Pamplona, Navarra, 31008

Site Contact

Ana Tabar, Phd, MD


+34 639151974

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.