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New treatment option for Peanut Allergy
Official title Study of ENP-501 in Peanut-Allergic and Non-Allergic Participants
ClinicalTrials.gov ID: NCT07117669
What this study is testing
What is ENP-501?
ENP-501 is an investigational medicine, given as an once-daily, 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
- This is a Phase 1/2 study to evaluate the safety and clinical activity of ENP-501 in non-peanut allergic (NPA) healthy participants and participants with an established peanut allergy (PA)
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Part 1:
- 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...
You likely can't join if
- 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...
- Poorly controlled atopic dermatitis
- Eosinophilic gastrointestinal disease
See the full eligibility criteria
- Part 1:
- 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...
- 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 Part 1 Cohort 1 only (NPA Participants)
- 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 Part 1 Cohort 2 only (PA Participants)
- 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:
- Positive Skin Prick Test (SPT) (wheal diameter of ≥ 8 mm) to peanut
- An elevated serum peanut specific IgE level ≥ 7 kUA/L (ImmunoCAP®)
- An Ara-h2 IgE level of ≥ 2 kUA/L (ImmunoCAP®) Part 2:
- 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:
- Positive SPT (wheal diameter of ≥ 3 mm) to peanut
- Serum peanut-specific IgE level ≥ 0.7 kUA/L (ImmunoCAP®)
- An Ara-h2 IgE level of ≥ 0.5 kUA/L (ImmunoCAP®) within 1 year of enrollment
- 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...
- 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...
- 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
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 14 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. 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.