Study of ENP-501 for Peanut Allergy
This study is testing a drug called ENP-501 for people with peanut allergy, as well as healthy individuals without peanut allergy. The main goal is to see how safe ENP-501 is and if it causes any side effects. Participants will receive ENP-501 or a placebo (an inactive substance) daily, applied to the inside of the cheek, for several weeks or up to a year. The study is looking for side effects and how well people tolerate the treatment. You may be able to join if you are between 14 and 50 years old. The current recruitment status is unclear.
- Study design
- This is a Phase 1/2 interventional study, meaning it's an early-stage trial looking at safety and initial effectiveness. It plans to enroll 68 participants.
- What's involved
- Participants will receive daily buccal (inside the cheek) administrations of ENP-501 or placebo for 6-14 weeks in Part 1, and for 52 weeks in Part 2 after reaching a specific dose. You will also need to be able to perform spirometry testing (a breathing test).
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary safety endpoints are measured up to 22 weeks.
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NCT07117669
Study of ENP-501 in Peanut-Allergic and Non-Allergic Participants
Recruiting
PHASE1Ages 14–50InterventionalTreatmentN-Fold, LLC
~68 participants
Updated 2026-04-24 on ClinicalTrials.gov
What's tested:ENP-501Placebo
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v 5.0 in Part 1
Measured over Up to 22 Weeks
+7 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesColorado1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
14-50 years of age (inclusive)
Otherwise medically healthy and able to participate in the study
Able to perform spirometry testing in accordance with the American Thoracic Society (ATS) guidelines (2019)
All women of child-bearing potential, agree to either abstain from sexual activity or agree to use an adequate method of contraception for the duration of the study and for 30 days after the last dose of investigational product
Signed and dated written informed consent from the participant and/or parent or guardian
Signed and dated assent from participant under 18 in accordance with local IRB regulations
Willing and able to avoid peanut and peanut contaminants for the duration of the trial
No known clinical history of peanut allergy with regular exposure to peanuts in daily life, i.e ingests peanuts without symptoms
Negative Skin Prick Test (SPT) (wheal diameter of \<3 mm) to peanut
A documented clinical history of peanut allergy, which includes the development of symptoms (e.g., urticaria, flushing, rhinorrhea and sneezing, throat tightness or hoarseness, wheezing, vomiting) verified by a physician
At least two of the three following requirements:
14 to 50 years of age (inclusive)
A documented clinical history of peanut allergy, which includes the development of symptoms (e.g., urticaria, flushing, rhinorrhea and sneezing, throat tightness or hoarseness, wheezing, vomiting) verified by a physician
At least two of the three following requirements at screening:
Participant must be willing and able to complete a DBPCFC at screening and EOT (24-hours after last dose) and experience dose-limiting symptoms at or before the 300 mg challenge dose of peanut protein during a Double Blind, Placebo Controlled Food Challenge (DBPCFC) conducted in accordance with Practical Issues in Allergology, Joint United States/European Union Initiative (PRACTALL) guidelines
Otherwise medically healthy and able to participate in the study
Able to perform spirometry testing in accordance with the ATS guidelines (2019)
All women of child-bearing potential, agree to either abstain from sexual activity or agree to use an adequate method of contraception for the duration of the study and for 30 days after the last dose of investigational product
Signed and dated written informed consent from the participant and/or parent or guardian
Signed and dated assent from participant under 18 in accordance with local IRB regulations
Willing and able to avoid peanut and peanut contaminants for the duration of the trial
Exclusion
History of severe anaphylactic event requiring mechanical ventilation or use of intravenous (IV) vasopressor drugs
Clinically significant screening electrocardiogram (ECG) abnormality or corrected QTcF \>/= 450 msec at Screening
FEV1 value \< 80% predicted at Screening
Any hospitalization in the past year for asthma, \>1 course of oral steroids for asthma in the past 6 months, or any emergency room visit in the past 6 months for asthma
Poorly controlled atopic dermatitis
Eosinophilic gastrointestinal disease
Use of oral or IV corticosteroids within 30 days of Screening
Use of tricyclic antidepressants within 6 months of Screening
Inability to discontinue antihistamines for at least 5 half-lives before skin testing
Use of omalizumab or other immunomodulatory therapy (not including corticosteroids) or biologic therapy within one year of Screening
Use of any food allergen-specific or other non-traditional form of allergen immunotherapy within one year of Screening
Use of immunosuppressive drugs within 30 days of Screening
Use of ß-blockers (oral)
Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urinalysis
Pregnant or breast-feeding (if female)
Behavioral, cognitive, or psychiatric disease that in the opinion of the Investigator affects the ability of the participant to understand and cooperate with the study protocol
Known allergy to inactive ingredients of investigational product (active or placebo)
Participation in another interventional clinical trial within 30 days of Screening or within 5 half-lives of the other IP
Residing at the same address as another participant in this or any peanut immunotherapy study
What this trial measures
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v 5.0 in Part 1Up to 22 Weeks
- Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) as Assessed by NCI CTCAE v 5.0 in Part 1Up to 22 Weeks
- Number of Participants with Dose Limiting Toxicities (DLTs) as Assessed by NCI CTCAE v 5.0 in Part 1Up to 22 Weeks
- Number of Participants with Systemic Reactions as Assessed by NCI CTCAE v 5.0 in Part 1Up to 22 Weeks
- Number of Participants with changes in Clinical Laboratory Values in Part 1Up to 22 Weeks
- Number of Participants with changes in Physical Examination in Part 1Up to 22 Weeks
- Number of Participants with changes in Vital Signs in Part 1Up to 22 Weeks
- Proportion of Participants Tolerating ≥1043 mg Cumulative Peanut Protein Without Dose-Limiting Symptoms at End of Treatment (EOT) Visit Double-Blind Placebo-Controlled Food Challenge (DBPCFC) Compared to Placebo in Part 2Up to 72 Weeks