Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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|
- - 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.
- - 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.
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|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|InnoUp Farma S.L.|
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|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.