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

NCT02851277 | Completed Phase 1 FDA Drug

• 1 other identifier: 0892-CL-1001
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Peanut Allergy

Keywords

Peanut Allergy; ASP0892

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (5)

Low dose ASP0892 Intradermal

EXPERIMENTAL

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

High dose ASP0892 Intradermal

EXPERIMENTAL

Participants will receive study drug once every 2 weeks for a total of 4 doses.

Drug: ASP0892 Intradermal

Placebo Intradermal

PLACEBO COMPARATOR

Participants will receive comparable Placebo once every 2 weeks for a total of 4 doses.

Drug: Placebo Intradermal

High dose ASP0892 Intramuscular

EXPERIMENTAL

Participants will receive study drug once every 2 weeks for a total of 4 doses.

Drug: ASP0892 Intramuscular

Placebo Intramuscular

PLACEBO COMPARATOR

Participants will receive comparable Placebo once every 2 weeks for a total of 4 doses.

Drug: Placebo Intramuscular

Interventions

ASP0892 Intradermal DRUG

Intradermal injection

High dose ASP0892 Intradermal; Low dose ASP0892 Intradermal

ASP0892 Intramuscular DRUG

Intramuscular injection

High dose ASP0892 Intramuscular

Placebo Intradermal DRUG

Intradermal injection

Placebo Intradermal

Placebo Intramuscular DRUG

Intramuscular injection

Placebo Intramuscular

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (8)

Site US10014

Little Rock, Arkansas, 72205, United States

Location

Site US10008

Mountain View, California, 94040, United States

Location

Site US10001

Baltimore, Maryland, 21287, United States

Location

Site US10002

Boston, Massachusetts, 02114, United States

Location

Site US10004

New York, New York, 10029-6574, United States

Location

Site US10003

Chapel Hill, North Carolina, 27599, United States

Location

Site US10012

Cincinnati, Ohio, 45241, United States

Location

Site US10006

Seattle, Washington, 98115, United States

Location

Related Publications (2)

• Ferslew BC, Smulders R, Zhu T, Blauwet MB, Kusawake T, Spence A, Aldridge K, DeBerg HA, Khosa S, Wambre E, Chichili GR. Safety and immunopharmacology of ASP0892 in adults or adolescents with peanut allergy: two randomized trials. Allergy. 2024 Feb;79(2):456-470. doi: 10.1111/all.15931. Epub 2023 Nov 27.

  PMID: 38010254 DERIVED

• 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.

  PMID: 32414772 DERIVED

Related Links

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

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Senior Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 1, 2016
• Study Start: December 13, 2016
• Primary Completion: December 6, 2018
• Study Completion: December 6, 2018
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)