Peanut AllergyPhase 1/2NCT04163562
Oral Immunotherapy for Peanut Allergic Patients
A Phase 1/2 study testing INP20 in people with Peanut Allergy, run by InnoUp Farma S.L. at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- INP20
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesSpain
- Study dates
- 11 Mar 2020to Sep 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Marta Ferrer, PhD, MD
Marta Ferrer, PhD, MD
- Recruiting
Complejo Hospittalario de Navarra
Pamplona, Navarre, 31008
Ana Tabar, Phd, MD
Ana Tabar, PhD, MD
About this study
Official title: A Multicenter Double-blind, Randomized, Placebocontrolled Phase I/II Study to Determine the Safety, Tolerability, Potential Efficacy and Dose Finding of INP20, an Oral Formulation for Treatment of Immunotherapy in Peanut-allergic Patients
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
- Being tested
- INP20, Placebo
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INP20Drug
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.
PlaceboDrug
Part A: Oral placebo administration onces daily for 2 weeks. Part B: Oral placebo administration onces daily for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| INP20 (Oral Immunotherapy) | Experimental | Not described Receives: Drug: INP20 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs)
Safety of the investigational product
Measured: Week 4 and Week 25
Number of patients experiencing any dose limiting toxicity (DLT)
Tolerability of the investigational product
Measured: Week 2
Secondary outcomes (2)
Change in Immunoglobulin G subtype (IgG4) and basophil activation on the BAT (basophil activation test).
Pharmacodynamics
Measured: Week 4
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
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start11 Mar 2020
- Primary completionMay 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnoUp Farma S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marta Ferrer, PhD, MD, Principal investigator, Clinica Universidad de NavarraAna Tabar, PhD, MD, Principal investigator, Complejo Hospitalario de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163562
- Sponsor's protocol ID
- INP20-01
- Status last verified
- Apr 2025
- First submitted
- 12 Nov 2019
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Double-blind, Randomized, Placebocontrolled Phase I/II Study to Determine the Safety, Tolerability, Potential Efficacy and Dose Finding of INP20, an Oral Formulation for Treatment of Immunotherapy in Peanut-allergic Patients
- ClinicalTrials.gov ID
- NCT04163562
- Acronym / sponsor ID
- INP20-01
- Conditions
- Peanut Allergy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- InnoUp Farma S.L.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INP20 (Oral Immunotherapy) | Experimental | Drug: INP20 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INP20Part 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 | INP20 (Oral Immunotherapy) |
| PlaceboPart A: Oral placebo administration onces daily for 2 weeks. Part B: Oral placebo administration onces daily for 6 months. | Drug | Placebo |
Primary outcome
Incidence rate, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Week 4 and Week 25
Safety of the investigational product
Number of patients experiencing any dose limiting toxicity (DLT)
Time frame: Week 2
Tolerability of the investigational product
2 secondary outcomes
Change in Immunoglobulin G subtype (IgG4) and basophil activation on the BAT (basophil activation test).
Time frame: Week 4
Differences in reaction thresholds (challenge test) to peanut of treatment groups versus the placebo after 6 months of INP20 treatment.
Time frame: Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marta Ferrer, PhD, MD principal investigator
Clinica Universidad de Navarra
Ana Tabar, PhD, MD principal investigator
Complejo Hospitalario de Navarra
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INP20 in people with Peanut Allergy, run by InnoUp Farma S.L. at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maite Agüeros, PhD (+34 639151974, magueros@innoupfarma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs) (time frame: Week 4 and Week 25). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.