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Peanut AllergyPhase 1NCT02851277

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 study testing ASP0892 Intradermal and ASP0892 Intramuscular in people with Peanut Allergy, run by Astellas Pharma Global Development, Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Peanut Allergy
What is being tested?
ASP0892 Intradermal and ASP0892 Intramuscular
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
8 sitesUnited States
Study dates
13 Dec 2016to 6 Dec 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Site US10001

    Baltimore, Maryland, 21287

  • Site US10002

    Boston, Massachusetts, 02114

  • Site US10003

    Chapel Hill, North Carolina, 27599

  • Site US10012

    Cincinnati, Ohio, 45241

  • Site US10014

    Little Rock, Arkansas, 72205

  • Site US10008

    Mountain View, California, 94040

  • Site US10004

    New York, New York, 10029-6574

  • Site US10006

    Seattle, Washington, 98115

Other trials in United States

About this study

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

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
Being tested
ASP0892 Intradermal, ASP0892 Intramuscular, Placebo Intradermal, Placebo Intramuscular
Keywords
Peanut Allergy, ASP0892
Medical subject headings
Peanut Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASP0892 IntradermalDrug

    Intradermal injection

  • ASP0892 IntramuscularDrug

    Intramuscular injection

  • Placebo IntradermalDrug

    Intradermal injection

  • Placebo IntramuscularDrug

    Intramuscular injection

Study groups in NCT02851277
Study groupRoleWhat they receive
Low dose ASP0892 IntradermalExperimentalParticipants 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.
Receives: Drug: ASP0892 Intradermal
High dose ASP0892 IntradermalExperimentalParticipants will receive study drug once every 2 weeks for a total of 4 doses.
Receives: Drug: ASP0892 Intradermal
Placebo IntradermalPlacebo comparatorParticipants will receive comparable Placebo once every 2 weeks for a total of 4 doses.
Receives: Drug: Placebo Intradermal
High dose ASP0892 IntramuscularExperimentalParticipants will receive study drug once every 2 weeks for a total of 4 doses.
Receives: Drug: ASP0892 Intramuscular
Placebo IntramuscularPlacebo comparatorParticipants will receive comparable Placebo once every 2 weeks for a total of 4 doses.
Receives: Drug: Placebo Intramuscular

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety as assessed by number of participants with Treatment-Emergent Adverse Events (TEAEs)

    Measured: Up to Day 360

  2. Safety as assessed by Vital sign: body temperature

    Measured: Up to Day 360

  3. Safety as assessed by Vital sign: blood pressure

    Measured: Up to Day 360

  4. Safety as assessed by Vital sign: pulse rate

    Measured: Up to Day 360

  5. Safety as assessed by 12- lead Electrocardiograms (ECGs)

    The overall conclusion will be recorded as normal and abnormal (not clinically significant/ clinically significant).

    Measured: Up to Day 360

  6. Safety as assessed by Laboratory test: hematology

    Measured: Up to Day 360

  7. Safety as assessed by Laboratory test: biochemistry

    Measured: Up to Day 360

  8. Safety as assessed by Laboratory test: urinalysis

    Measured: Up to Day 360

  9. Safety as assessed by Anti-Lysosomal associated membrane protein-1 (LAMP-1) antibody

    Measured: Up to Day 360

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2016 (estimated)
  2. Study start13 Dec 2016
  3. Primary completion6 Dec 2018
  4. Study completion6 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02851277
Sponsor's protocol ID
0892-CL-1001
Status last verified
Oct 2024
First submitted
28 Jul 2016
Last updated
23 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • 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.

    PubMed 38010254

  • 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.

    PubMed 32414772

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASP0892 Intradermal and ASP0892 Intramuscular in people with Peanut Allergy, run by Astellas Pharma Global Development, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety as assessed by number of participants with Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to Day 360). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02851277, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.

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