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New treatment option for Peanut Allergy
Official title Oral Immunotherapy for Peanut Allergic Patients
ClinicalTrials.gov ID: NCT04163562
What this study is testing
What is INP20?
INP20 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for peanut allergy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 65
You may be able to join 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] \>...
- A history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts.
- Have a positive blinded compared with an inactive treatment food challenge (DBPCFC) to peanut at a cumulative dose of less than 10 grams of peanut...
- Provide signed informed consent for the participation in the study.
- Have self-injectable epinephrine available at home and be trained on its proper use.
You likely can't join if
- History of severe anaphylaxis to peanut as defined by respiratory distress with cyanosis, hypoxemia (O2 Sat \<92%) or, in the absence of other...
- Currently participating in another study using an investigational new drug.
- Participation in any treatment study, specific oral or sublingual immunotherapy building up phase for the treatment of food allergy in the past 12...
- 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.
See the full eligibility 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 blinded compared with an inactive treatment 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...
- Currently participating in another study using an investigational new drug.
- Participation in any treatment 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Pamplona, Navarre, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pamplona, Navarre, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.