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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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier:
NCT02851277
First received: July 28, 2016
Last updated: April 13, 2017
Last verified: April 2017
  Purpose
The purpose of this study is to evaluate the safety and tolerability of ASP0892 after intradermal or intramuscular injection in adults with peanut allergy.

Condition Intervention Phase
Peanut Allergy Drug: ASP0892 Intradermal Drug: ASP0892 Intramuscular Drug: Placebo Intradermal Drug: Placebo Intramuscular Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):

Primary Outcome Measures:
  • Safety as assessed by number of participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Day 211 ]
  • Safety as assessed by Vital sign: body temperature [ Time Frame: Up to Day 211 ]
  • Safety as assessed by Vital sign: blood pressure [ Time Frame: Up to Day 211 ]
  • Safety as assessed by Vital sign: pulse rate [ Time Frame: Up to Day 211 ]
  • Safety as assessed by 12- lead Electrocardiograms (ECGs) [ Time Frame: Up to Day 211 ]
    The overall conclusion will be recorded as normal and abnormal (not clinically significant/ clinically significant).

  • Safety as assessed by Laboratory test: hematology [ Time Frame: Up to Day 211 ]
  • Safety as assessed by Laboratory test: biochemistry [ Time Frame: Up to Day 211 ]
  • Safety as assessed by Laboratory test: urinalysis [ Time Frame: Up to Day 211 ]
  • Safety as assessed by Anti-Lysosomal associated membrane protein (LAMP) antibody [ Time Frame: Up to Day 211 ]

Estimated Enrollment: 30
Actual Study Start Date: November 15, 2016
Estimated Study Completion Date: July 10, 2018
Estimated Primary Completion Date: July 10, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 for 5 half-lives prior to dosing, skin prick testing, and oral food challenge procedure.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02851277

Contacts
Contact: Astellas Pharma Global Development 800-888-7704 ext 5473 astellas.registration@astellas.com

Locations
United States, California
Site US10008 Recruiting
Mountain View, California, United States, 94040
United States, Illinois
Site US10009 Recruiting
Chicago, Illinois, United States, 60637
United States, Maryland
Site US10001 Recruiting
Baltimore, Maryland, United States, 21287
United States, New York
Site US10004 Recruiting
New York, New York, United States, 10029-6574
United States, North Carolina
Site US10003 Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Site US10012 Recruiting
Cincinnati, Ohio, United States, 45241
United States, Washington
Site US10006 Recruiting
Seattle, Washington, United States, 98115
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
Study Director: Senior Medical Director Astellas Pharma Global Development, Inc.
  More Information

Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT02851277     History of Changes
Other Study ID Numbers: 0892-CL-1001
Study First Received: July 28, 2016
Last Updated: April 13, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
Peanut Allergy
ASP0892

Additional relevant MeSH terms:
Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 22, 2017