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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
* Part 1: Participants will receive buccal administrations of ENP-501 daily for 6-14 weeks * Part 2: Participants will receive buccal administrations of ENP-501 daily for 52 weeks following achieving the 2000 µg target dose
* Part 1: Participants will receive buccal administrations of placebo daily for 6-14 weeks * Part 2: Participants will receive buccal administrations of placebo daily for 52 weeks following achieving the 2000 µg target dose
Research Site 001
Aurora, Colorado, United States
RECRUITINGNumber of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v 5.0 in Part 1
Time frame: Up to 22 Weeks
Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) as Assessed by NCI CTCAE v 5.0 in Part 1
Time frame: Up to 22 Weeks
Number of Participants with Dose Limiting Toxicities (DLTs) as Assessed by NCI CTCAE v 5.0 in Part 1
Time frame: Up to 22 Weeks
Number of Participants with Systemic Reactions as Assessed by NCI CTCAE v 5.0 in Part 1
Time frame: Up to 22 Weeks
Number of Participants with changes in Clinical Laboratory Values in Part 1
Time frame: Up to 22 Weeks
Number of Participants with changes in Physical Examination in Part 1
Time frame: Up to 22 Weeks
Number of Participants with changes in Vital Signs in Part 1
Time frame: Up 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 2
Time frame: Up to 72 Weeks
Number of Participants Able to Tolerate 2000 µg Dose of ENP-501 Without Experiencing Dose-Limiting Toxicity (DLT) in Part 1
Time frame: Up to 22 Weeks
Change in Total IgE Levels in Part 1
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Time frame: Screening and Week 22 (EOS)
Change in Ara h 1-Specific IgE Levels in Part 1
Time frame: Screening and Week 22 (EOS)
Change in Ara h 2-Specific IgE Levels in Part 1
Time frame: Screening and Week 22 (EOS)
Change in Ara h 3-Specific IgE Levels in Part 1
Time frame: Screening and Week 22 (EOS)
Change in Ara h 1-Specific IgG4 Levels in Part 1
Time frame: Screening and Week 22 (EOS)
Change in Ara h 2-Specific IgG4 Levels in Part 1
Time frame: Screening and Week 22 (EOS)
Change in Ara h 3-Specific IgG4 Levels in Part 1
Time frame: Screening and Week 22 (EOS)
Change in Wheal Diameter on Skin Prick Test (SPT) to Peanut in Part 1
Time frame: Screening and Week 22 (EOS)
Proportion of Participants Tolerating at Least 443 mg Cumulative Dose of Peanut Protein Without Dose-Limiting Symptoms at EOT Visit DBPCFC Compared to Placebo in Part 2
Time frame: Up to 72 Weeks
Proportion of Participants Tolerating at Least 2043 mg Cumulative Dose of Peanut Protein Without Dose-Limiting Symptoms at EOT Visit DBPCFC Compared to Placebo in Part 2
Time frame: Up to 72 Weeks
Proportion of Participants Tolerating 4043 mg Cumulative Dose of Peanut Protein Without Dose-Limiting Symptoms at EOT Visit DBPCFC Compared to Placebo in Part 2
Time frame: Up to 72 Weeks
Maximum Severity of Symptoms Occurring at Each Challenge Dose of Peanut Protein During the Exit DBPCFC in Part 2
Time frame: Up to 72 Weeks
Number of Participants Able to Tolerate the 2000 µg Dose of ENP-501 in Part 2
Time frame: Up to 72 Weeks
Change in Total IgE Levels in Part 2
Time frame: Screening and Week 72 (EOS)
Change in Ara h 1-Specific IgE Levels in Part 2
Time frame: Screening and Week 72 (EOS)
Change in Ara h 2-Specific IgE Levels in Part 2
Time frame: Screening and Week 72 (EOS)
Change in Ara h 3-Specific IgE Levels in Part 2
Time frame: Screening and Week 72 (EOS)
Change in Ara h 1-Specific IgG4 Levels in Part 2
Time frame: Screening and Week 72 (EOS)
Change in Ara h 2-Specific IgG4 Levels in Part 2
Time frame: Screening and Week 72 (EOS)
Change in Ara h 3-Specific IgG4 Levels in Part 2
Time frame: Screening and Week 72 (EOS)
Change in Wheal Diameter on Skin Prick Test (SPT) to Peanut in Part 2
Time frame: Screening and Week 72 (EOS)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v 5.0 in Part 2
Time frame: Up to 72 Weeks
Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) as Assessed by NCI CTCAE v 5.0 in Part 2
Time frame: Up to 72 Weeks
Number of Participants with TEAEs leading to discontinuation as Assessed by NCI CTCAE v 5.0 in Part 2
Time frame: Up to 72 Weeks
Number of Participants with Systemic Reactions as Assessed by NCI CTCAE v 5.0 in Part 2
Time frame: Up to 72 Weeks
Number of Participants with changes in Clinical Laboratory Values in Part 2
Time frame: Up to 72 Weeks
Number of Participants with changes in Physical Examination in Part 2
Time frame: Up to 72 Weeks
Number of Participants with changes in Vital Signs in Part 2
Time frame: Up to 72 Weeks