Clinical trial NCT05476497: Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects
Official title: A Phase I Clinical Trial to Evaluate the Safety and Tolerability of VLP Peanut in Healthy Subjects and Subjects With Peanut Allergy and to Explore Preliminary Signals of Its Efficacy (PROTECT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Peanut Allergy
Lead sponsor: Allergy Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-07-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Two part clinical trial:

Part A- Open-label with two groups (A1 and A2):

i) A1 (Healthy Subjects): subcutaneous (SC) dosing with ascending concentrations of VLP Peanut.

ii) A2 (peanut allergic subjects): skin prick test (SPT) performed with ascending concentrations of VLP Peanut.

Part B - double-blind, placebo-controlled part that will enroll Peanut Allergic Subjects: subcutaneous (SC) dosing with ascending concentrations of VLP Peanut.
Primary purpose: TREATMENT

Brief summary: This phase I clinical trial is designed to evaluate the safety and tolerability of VLP Peanut in healthy subjects and in subjects with peanut allergy (PA). This clinical trial will evaluate the immunotoxicity profile of VLP Peanut in healthy subjects and assess the immunotoxicity profile and the degree of reactogenicity (allergenicity) in subjects with PA. This clinical trial will also explore preliminary proof of efficacy of VLP Peanut in subjects with PA.


Eligibility criteria: Part A Main Inclusion Criteria:

1. Capable of giving signed informed consent.
2. Subject who has a signed and dated Informed Consent Form (ICF).
3. Subject must be 18 to 50 years inclusive, at the time of signing the ICF.
4. Male or female.
5. Female subjects who are not of childbearing potential (or females of childbearing potential who agree to comply with the contraceptive requirements of the clinical trial protocol).
6. Good general health, as determined by the Investigator.
7. A positive SPT to histamine.

   The following additional inclusion criteria are only applicable to the healthy subjects in Group A1:
8. Healthy subjects (non-atopic) with no clinically significant co-morbidity (including broncho-reactive airway disease like asthma, current allergic rhinitis, etc.).
9. Subjects with no history of allergy or intolerance to peanut or any other food and who consume peanuts with no effect.
10. Subjects with lack of sensitivity to peanut allergen confirmed by SPT using whole peanut extract.
11. Peanut specific immunoglobulin E (IgE) \<0.35 kU/L.
12. Ara h 2 specific IgE \<0.35 kU/L.
13. Subjects with negative basophil activation test (BAT).

    The following additional inclusion criteria are only applicable to the subjects with PA in Group A2:
14. Clinical history of physician diagnosed PA.
15. Peanut allergen sensitivity confirmed by SPT and IgE.
16. Subjects who currently adhere to a strict peanut-free diet and who agree to continue this for the duration of the clinical trial.
17. Subjects who are able to handle and correctly use an adrenaline auto-injector.

Part B Main Inclusion Criteria:

1. Capable of giving signed informed consent.
2. Subject who has a signed and dated ICF.
3. Subjects aged 18 to 50 years of age inclusive, at the time of signing the ICF.
4. Male or female.
5. Female subjects who are not of childbearing potential (or females of childbearing potential who agree to comply with the contraceptive requirements of the clinical trial protocol).
6. Clinical history of physician diagnosed PA.
7. Peanut allergen sensitivity confirmed by SPT and IgE (Peanut specific IgE ≥5.0 kU/L and Ara h 2 specific IgE ≥2.0 kU/L)
8. Subjects with positive BAT.
9. Subjects who currently adhere to a strict peanut-free diet and who agree to continue this for the duration of the clinical trial.
10. Good general health, as determined by the Investigator.
11. Subjects who are able to handle and correctly use an adrenaline auto-injector.

Main Exclusion Criteria Part A and B:

1. Pregnant or lactating subject.
2. Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
3. Subjects with atopic dermatitis with \>25% skin surface involvement.
4. For subjects with PA, presence of severe, poorly controlled or uncontrolled asthma.
5. History of severe or life-threatening anaphylactic reactions to peanut resulting in neurological compromise or requiring mechanical ventilation.
6. History of severe or life-threatening anaphylactic reactions to foods (excluding peanuts), insect venom, exercise, drugs, or idiopathic causes, resulting in neurological compromise or requiring mechanical ventilation or deemed severe as per Investigator assessment.
7. Unable to receive epinephrine therapy or at greater risk of developing adverse reactions after epinephrine administration as assessed by the site Investigator.
8. Clinical history of drug or alcohol abuse, which, in the Investigator's opinion, could interfere with the subject's ability to participate in the clinical trial.
9. Participation in a clinical research trial with any investigational drug/placebo within 3 months of screening (Visit 1) or concomitantly with this clinical trial.
10. Personal, financial or other dependent relationship (e.g., employee or immediate relative) with the clinical trial site, Sponsor, Sponsor's representative, or another individual who has access to the clinical trial protocol.
11. Vulnerable subjects or those in judicial or governmental detention, detainment or imprisonment in a public institution.

Primary outcomes:
measure: Number and severity of Adverse Events (AEs) (including local and systemic AEs).
timeFrame: Group A1: 18 weeks; Part B: 64 weeks (Part B). Group A2: 3 days.
measure: Number of subjects discontinuing prematurely from treatment due to AEs
timeFrame: Group A1: 11 weeks Part B: 15 weeks
Secondary outcomes:
measure: Incidence of fatigue (tiredness)
timeFrame: Group A1: 14 weeks Part B: 16 weeks
measure: Frequency of fatigue (tiredness)
timeFrame: Group A1: 14 weeks Part B: 16 weeks
measure: Incidence of headache
timeFrame: Group A1: 14 weeks Part B: 16 weeks
measure: Frequency of headache
timeFrame: Group A1: 14 weeks Part B: 16 weeks
measure: Incidence of muscle pain
timeFrame: Group A1: 14 weeks Part B: 16 weeks
measure: Frequency of muscle pain
timeFrame: Group A1: 14 weeks Part B: 16 weeks
measure: Incidence of cough
timeFrame: Group A1: 14 weeks Part B: 16 weeks
measure: Frequency of cough
timeFrame: Group A1: 14 weeks Part B: 16 weeks
measure: Incidence of sore throat
timeFrame: Group A1: 14 weeks Part B: 16 weeks
measure: Frequency of sore throat
timeFrame: Group A1: 14 weeks Part B: 16 weeks
measure: Incidence of runny nose
timeFrame: Group A1: 14 weeks Part B: 16 weeks
measure: Frequency of runny nose
timeFrame: Group A1: 14 weeks Part B: 16 weeks
measure: Incidence of chills
timeFrame: Group A1: 14 weeks Part B: 16 weeks
measure: Frequency of chills
timeFrame: Group A1: 14 weeks Part B: 16 weeks
measure: Incidence of fever (i.e. body temperature equal or above 38ºC (100.4ºF))
timeFrame: Group A1: 14 weeks Part B: 16 weeks
measure: Frequency of fever (i.e. body temperature equal or above 38ºC (100.4ºF))
timeFrame: Group A1: 14 weeks Part B: 16 weeks
measure: Wheal sizes after SPT in subjects with PA (Part A only)
timeFrame: 15-20 minutes after skin pricking
measure: Respiratory and Cardiovascular System Alterations as assessed by brief physical examination
timeFrame: On each dosing day - Group A1/Group part B: pre-dose and 30+/-10 minutes post dose; Group A2: pre-skin pricking and 1 hour post-skin pricking
measure: Alterations in the lung function
timeFrame: Group A1 and Group Part B: On each dosing day pre-dose and 30 to 60 minutes post-dose; Group A2: pre skin pricking and 1 hour post skin pricking
measure: Alterations in urine pH
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in urinalysis (protein)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in urinalysis (glucose)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in urinalysis (ketones)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in urinalysis (urobilinogen)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in urinalysis (bilirubin)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in urinalysis (nitrite)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Urinalysis (blood)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Urinalysis (leukocytes)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Serum Chemistry (Glucose)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Serum Chemistry (Sodium)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Serum Chemistry (Uric Acid)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Serum Chemistry (Urea)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Serum Chemistry (potassium)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Serum Chemistry (Calcium)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Serum Chemistry (Creatinine)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Serum Chemistry (chloride)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Serum Chemistry (total protein)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Serum Chemistry (phosphorus)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Serum Chemistry (cholesterol)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Serum Chemistry (albumin)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Serum Chemistry (total bilirubin)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Serum Chemistry (alkaline phosphatase)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Serum Chemistry (lactate dehydrogenase)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Serum Chemistry (aspartate aminotransferase)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Serum Chemistry (Alanine aminotransferase)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Serum Chemistry (gamma-glutamyl transferase)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Serum Chemistry (C-reactive protein)
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in hemoglobin levels
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in the hematocrit
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in Red Blood Cells (RBC) levels
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Alterations in White Blood Cells (WBC) levels
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Platelet counts alterations
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
measure: Serum/Urine Pregnancy Test
timeFrame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Houston
country: United States
facility: Trio Clinical Trials, LLC.
state: Texas
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research
state: Wisconsin
Study officials:
affiliation: Allergy Therapeutics
name: Pieter-Jan De Kam, PhD
role: STUDY_DIRECTOR
References: