A Study to Evaluate Safety, Tolerability and Immune Response in Adults Allergic to Peanut After Receiving Intradermal or Intramuscular Administration of ASP0892 (ARA-LAMP-vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine

A Phase 1, Randomized, Placebo Controlled Study to Evaluate Safety, Tolerability and Immune Response in Adults Allergic to Peanut After Receiving Intradermal or Intramuscular Administration of ASP0892 (ARA LAMP Vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine

The purpose of this study is to evaluate the safety and tolerability of ASP0892 after intradermal or intramuscular injection in adults with peanut allergy.

Study Overview

• Status: Completed
• Conditions: Peanut Allergy
• Intervention / Treatment: Drug: ASP0892 Intradermal; Drug: Placebo Intradermal; Drug: ASP0892 Intramuscular; Drug: Placebo Intramuscular

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Site US10014
  • California
    • Mountain View, California, United States, 94040
      • Site US10008
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Site US10001
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Site US10002
  • New York
    • New York, New York, United States, 10029-6574
      • Site US10004
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Site US10003
  • Ohio
    • Cincinnati, Ohio, United States, 45241
      • Site US10012
  • Washington
    • Seattle, Washington, United States, 98115
      • Site US10006

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject has a body mass index (BMI) ≥ 18 and 32 at screening.
• Subject has a physician-diagnosed peanut allergy or history of peanut allergy. Subjects with history of nonsevere anaphylaxis (Grade ≤ 3) to peanuts (including mild wheezing or dyspnea without hypoxia) will be enrolled.
• Subject has an anti-Ara h2 IgE measured by ImmunoCAP > 0.35 kU/L.
• Subject has a positive SPT to peanut with a change in wheal diameter ≥ 3 mm as compared to a negative control.
• Subject has a positive peanut double-blinded placebo-controlled food challenge (DBPCFC) at Screen 2 visit with an eliciting dose ≤ 300 mg peanut protein (≤ 444 mg cumulative reactive dose [CRD]).

• Female subject must either:

  • Be of non-child bearing potential: post-menopausal (defined as at least 1 year without any menses) prior to screening, or documented surgically sterile.
  • Or, if of childbearing potential: Agree not to become pregnant during the study; and have a negative (urine) pregnancy test result at screening and at day 1 (predose); and, if heterosexually active, agree to consistently use 2 forms of highly effective birth control (at least one of which must be a barrier method) starting at screening and throughout the study period.
• Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 28 days after the final study drug administration.
• Female subject must not donate ova starting at screening and throughout the study period, and for 28 days after the final study drug administration.
• Male subject and female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (at least one of which must be a barrier method) starting at screening and continue throughout the study period, and for 90 days after the final study drug administration.
• Male subject must not donate sperm starting at screening and throughout the study period, and for 90 days after the final study drug administration.

Exclusion Criteria:

• Subject has severe anaphylaxis to peanuts (Grades 4 or 5 including dyspnea associated with hypoxia, cyanosis, hypotension, or neurological compromise) per the Grading of Food-Induced Anaphylaxis According to Severity of Clinical Symptoms based on historical clinical symptoms.
• Subject develops a Grade 4 or 5 reaction during the DBPCFC.
• Subject who has received or is planning to receive administration of any vaccine (other than injectable Influenza vaccine) within 28 days prior to the administration of the study vaccine or at any time during the study.
• Subject who received any specific immunotherapy for allergy (e.g., epicutaneous immunotherapy [EPIT], sublingual immunotherapy [SLIT], subcutaneous immunotherapy [SCIT], and oral immunotherapy [OIT]) during the past 12 months, currently, or plans to receive during the course of the study.

• Subject who has used the following drug(s) prior to the dosing of the study vaccine:

  • Within 2 months prior to study vaccine administration: Systemic (or inhaled) steroid, chemical mediator-isolation inhibitor, Th2 cytokine inhibitor, thromboxane A2 synthesis inhibitor, thromboxane A2 receptor antagonist, β-blocker, angiotensin-converting enzyme inhibitors, and/or angiotensin-receptor blockers
  • Within 3 months prior to study vaccine administration: Biologics and/or immune modulators (including anti-TNFα antibody and anti-IgE monoclonal antibody)
• Subject who has history of allergic reactions such as anaphylactic shock, angioedema with airway constriction or hypotension caused by food other than peanut and/or medical products (including vaccine) in the past.
• Subject's laboratory test results at screening or prior to study vaccine dosing on day 1 are outside the normal limits and considered to be clinically significant.
• Subject with anti-LAMP-1 antibodies above the cut-point for the Tier 1 assay and who is confirmed positive in the Tier 2 assay at Screen 1 visit (baseline).
• Subject who had a positive test results for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen/ antibody.
• Subject who has immune disorders (including autoimmune disease) and/or diseases requiring immunosuppressive drugs.
• Subject who was diagnosed with immunodeficiency in the past.
• Subject who has uncontrolled hypertension.
• Subject who has a history of cardiovascular disease, arrhythmias, chronic lung disease, active eosinophilic gastrointestinal disease, or any other medical or surgical conditions which places the subject at increased risk for participation in the study.
• Subject who has a complication or medical history of respiratory disease which requires medical treatment.
• Subject who has a complication or medical history of malignant tumor.
• Subject who has mental conditions such as schizophrenia, bipolar disorder, and major depressive disorder, or a subject who has received drug(s) for the treatment of dementia.
• Subject who has severe or poorly controlled dermatitis atopic or generalized eczema.

• Subject who is unable to discontinue antihistamines within 7 days or 5 half-lives (whichever duration is longer) as follows:

  • prior to dosing through 7 days post last dose of study vaccine
  • prior to skin prick testing and oral food challenge procedures
• Subject who has asthma other than mild intermittent asthma (National Heart, Lung, and Blood Institute [NHLBI] guidelines) and has a FEV1 value < 80% and/or requiring chronic maintenance treatment (i.e., inhaled corticosteroids).
• Subject who has already received vaccination of LAMP-vax such as ASP0892.
• Subject who has received investigational therapy within 35 days or 5 half- lives whichever is longer, prior to screening.
• Subject who is an employee of the Astellas Group or vendors involved in the study.
• Subject who has any condition which makes the subject unsuitable for study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Low dose ASP0892 Intradermal; Participants will receive study drug once every 2 weeks for a total of 4 doses. After participants complete the Low dose arms, the Dose Escalation Committee (DEC) will determine if the study can progress to the parallel higher dose arms.	Drug: ASP0892 Intradermal; Intradermal injection
EXPERIMENTAL: High dose ASP0892 Intradermal; Participants will receive study drug once every 2 weeks for a total of 4 doses.	Drug: ASP0892 Intradermal; Intradermal injection
PLACEBO_COMPARATOR: Placebo Intradermal; Participants will receive comparable Placebo once every 2 weeks for a total of 4 doses.	Drug: Placebo Intradermal; Intradermal injection
EXPERIMENTAL: High dose ASP0892 Intramuscular; Participants will receive study drug once every 2 weeks for a total of 4 doses.	Drug: ASP0892 Intramuscular; Intramuscular injection
PLACEBO_COMPARATOR: Placebo Intramuscular; Participants will receive comparable Placebo once every 2 weeks for a total of 4 doses.	Drug: Placebo Intramuscular; Intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as assessed by number of participants with Treatment-Emergent Adverse Events (TEAEs)		Up to Day 360
Safety as assessed by Vital sign: body temperature		Up to Day 360
Safety as assessed by Vital sign: blood pressure		Up to Day 360
Safety as assessed by Vital sign: pulse rate		Up to Day 360
Safety as assessed by 12- lead Electrocardiograms (ECGs)	The overall conclusion will be recorded as normal and abnormal (not clinically significant/ clinically significant).	Up to Day 360
Safety as assessed by Laboratory test: hematology		Up to Day 360
Safety as assessed by Laboratory test: biochemistry		Up to Day 360
Safety as assessed by Laboratory test: urinalysis		Up to Day 360
Safety as assessed by Anti-Lysosomal associated membrane protein-1 (LAMP-1) antibody		Up to Day 360

Collaborators and Investigators

• Sponsor: Astellas Pharma Global Development, Inc.

Publications and helpful links

General Publications

• Reyes AJ, Hosein AS, Ramcharan K, Perot S. Anaphylaxis and other allergic reactions to food: a global challenge. BMJ Case Rep. 2020 May 14;13(5):e231425. doi: 10.1136/bcr-2019-231425.

Helpful Links

• Link to results on the Astellas Clinical Study Results website.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 13, 2016
• Primary Completion (ACTUAL): December 6, 2018
• Study Completion (ACTUAL): December 6, 2018

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (ESTIMATE): August 1, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Peanut Allergy; ASP0892
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nut and Peanut Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: 0892-CL-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No