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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

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ClinicalTrials.gov Identifier: NCT02851277
Recruitment Status : Completed
First Posted : August 1, 2016
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Tracking Information
First Submitted Date  ICMJE July 28, 2016
First Posted Date  ICMJE August 1, 2016
Last Update Posted Date December 5, 2019
Actual Study Start Date  ICMJE December 13, 2016
Actual Primary Completion Date December 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2019)
  • Safety as assessed by number of participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Day 360 ]
  • Safety as assessed by Vital sign: body temperature [ Time Frame: Up to Day 360 ]
  • Safety as assessed by Vital sign: blood pressure [ Time Frame: Up to Day 360 ]
  • Safety as assessed by Vital sign: pulse rate [ Time Frame: Up to Day 360 ]
  • Safety as assessed by 12- lead Electrocardiograms (ECGs) [ Time Frame: Up to Day 360 ]
    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 360 ]
  • Safety as assessed by Laboratory test: biochemistry [ Time Frame: Up to Day 360 ]
  • Safety as assessed by Laboratory test: urinalysis [ Time Frame: Up to Day 360 ]
  • Safety as assessed by Anti-Lysosomal associated membrane protein-1 (LAMP-1) antibody [ Time Frame: Up to Day 360 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Peanut Allergy
Intervention  ICMJE
  • Drug: ASP0892 Intradermal
    Intradermal injection
  • Drug: ASP0892 Intramuscular
    Intramuscular injection
  • Drug: Placebo Intradermal
    Intradermal injection
  • Drug: Placebo Intramuscular
    Intramuscular injection
Study Arms  ICMJE
  • 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.
    Intervention: Drug: ASP0892 Intradermal
  • Experimental: High dose ASP0892 Intradermal
    Participants will receive study drug once every 2 weeks for a total of 4 doses.
    Intervention: Drug: ASP0892 Intradermal
  • Placebo Comparator: Placebo Intradermal
    Participants will receive comparable Placebo once every 2 weeks for a total of 4 doses.
    Intervention: Drug: Placebo Intradermal
  • Experimental: High dose ASP0892 Intramuscular
    Participants will receive study drug once every 2 weeks for a total of 4 doses.
    Intervention: Drug: ASP0892 Intramuscular
  • Placebo Comparator: Placebo Intramuscular
    Participants will receive comparable Placebo once every 2 weeks for a total of 4 doses.
    Intervention: Drug: Placebo Intramuscular
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). pii: e231425. doi: 10.1136/bcr-2019-231425.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2019)
31
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2016)
30
Actual Study Completion Date  ICMJE December 6, 2018
Actual Primary Completion Date December 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02851277
Other Study ID Numbers  ICMJE 0892-CL-1001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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."
Responsible Party Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
Study Sponsor  ICMJE Astellas Pharma Global Development, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Senior Medical Director Astellas Pharma Global Development, Inc.
PRS Account Astellas Pharma Inc
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP