Peanut AllergyPhase 1NCT03755713
A Study to Evaluate Safety, Tolerability and Immune Response in Adolescents Allergic to Peanut After Receiving Intradermal 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 in people with Peanut Allergy, run by Astellas Pharma Global Development, Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of ASP0892 after intradermal (ID) injection in adolescent participants with peanut allergy. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- ASP0892
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 7 sitesUnited States
- Study dates
- 12 Mar 2019to 11 Oct 2021
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject has a body mass index (BMI) ≥ 3rd percentile and ≤ 97th percentile.
- 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 Immunoglobulin E (IgE) measured by ImmunoCAP > 0.35 kU/L.
- Subject has a positive Skin prick test (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-childbearing potential, clearly premenarchal; documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy).
- Or, if of childbearing potential, agrees not to try to become pregnant during the study; and have a negative urine pregnancy test at screening and at day 1 (predose); and if heterosexually active, agrees to consistently use 1 form of highly effective birth control 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.
- A heterosexually active male subject with female partner(s) who are of childbearing potential is eligible if:
- Agrees to use a male condom starting at screening and continue throughout study treatment and for 28 days after the final study drug administration. If the male subject has not had a vasectomy or is not sterile, the subjects female partner(s) is utilizing 1 form of highly effective birth control starting at screening and continue throughout study treatment and for 90 days after the male subject receives his 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 drug administration.
- Subject and subject's parent(s) or legal guardian agree that the subject will not participate in another interventional study while participating in the present study.
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, per the Grading of Food- Induced Anaphylaxis According to Severity of Clinical Symptoms based on historical clinical symptoms.
- Subject has received or is planning to receive administration of any vaccine (other than injectable Influenza vaccine) from 28 days prior to the first dose through 2 weeks after the last dose of the study vaccine.
- Subject 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 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, T helper cell type 2 (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 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 drug dosing on day 1 are outside the normal limits and are considered clinically significant.
- Subjects with anti-Lysosomal associated membrane protein (LAMP)-1 antibodies above the cut-point for the Tier 1 assay and who are confirmed positive in the Tier 2 assay at Screen 1 visit (baseline).
- Subject had a positive test result for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antigen/antibody.
- Subject had a positive urine drug screen result.
- Subject has immune disorders (including autoimmune disease) and/or diseases requiring immunosuppressive drugs.
- Subject was diagnosed with immunodeficiency in the past.
- Subject has uncontrolled hypertension.
- Subject 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 has a complication or medical history of respiratory disease, which requires medical treatment.
- Subject has a complication or medical history of malignant tumor.
- Subject has mental conditions such as schizophrenia, bipolar disorder, dementia or major depressive disorder.
- Subject has severe or poorly controlled atopic dermatitis or generalized eczema.
- Subject is unable to discontinue antihistamines within 7 days or 5 half-lives (whichever duration is longer) prior to SPT and oral food challenge procedures.
- Subject has asthma other than mild intermittent asthma (National Heart, Lung and Blood Institute [NHLBI] Guidelines, July 2007) and has a forced expiratory volume in 1 second value < 80% and/or requiring chronic maintenance treatment (i.e., inhaled corticosteroids).
- Subject has already received injection of Lysosomal associated membrane protein (LAMP)-vax such as ASP0892.
- Subject has received investigational therapy within 35 days or 5 half-lives, whichever is longer, prior to screening.
- Subject's parent(s) or legal guardian is an employee of the Astellas Group or vendors involved in the study.
- Subject has any condition, which, makes the subject unsuitable for study participation.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
The University of Chicago Medicine
Chicago, Illinois, 60637
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45241
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72205
Sean N Parker Center for Allergy & Asthma Research, LPCH El Camino Hospital
Mountain View, California, 94090
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Asthma, Inc.
Seattle, Washington, 98115
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability and Immune Response in Adolescents Allergic to Peanut After Receiving Intradermal 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 (ID) injection in adolescent participants with peanut allergy.
- Conditions
- Peanut Allergy
- Being tested
- ASP0892, Placebo
- Keywords
- ASP0892, Peanut Allergy
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP0892Drug
Intradermal
PlaceboDrug
Intradermal; normal saline solution
| Study group | Role | What they receive |
|---|---|---|
| ASP0892 Low Dose (Cohort A) | Experimental | Each cohort will consist of 10 participants (ASP0892 n = 8 and placebo n = 2). The data will be assessed by the Data Monitoring Committee (DMC) after all enrolled cohort A participants complete visits through day 43. Assessments for safety, tolerability, and dose escalation will occur prior to beginning cohort B. Receives: Drug: ASP0892 |
| ASP0892 High Dose (Cohort B) | Experimental | After all participants in cohort A complete study procedures, the DMC will review the safety and tolerability data and provide recommendations depending on the nature, frequency and severity of the safety profile reviewed. Recommendations will be to proceed with escalation to the next higher dose or stop dose escalation (i.e., no further dosing with study drug). Receives: Drug: ASP0892 |
| Placebo | Placebo comparator | Each cohort will consist of 10 participants (ASP0892 n = 8 and placebo n = 2). The data will be assessed by the Data Monitoring Committee (DMC) after all enrolled cohort A participants complete visits through day 43. Assessments for safety, tolerability, and dose escalation will occur prior to beginning cohort B. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by Treatment Emergent Adverse Events (TEAEs)
Adverse Events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). AEs starting or worsening after the first dose of study drug up through study completion will be considered treatment-emergent.
Measured: Up to Day 576
Safety as assessed by local reactogenicity reactions
Participants will be asked to record local reactogenicity (pain, tenderness; erythema/redness, Induration/Swelling) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (Potentially Life Threatening).
Measured: Up to Day 50
Safety as assessed by systemic reactogenicity reactions
Participants will be asked to record systemic reactogenicity (nausea/vomiting, diarrhea, headache, fatigue, myalgia) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (Potentially Life Threatening).
Measured: Up to Day 50
Number of participants with vital signs abnormalities and/or adverse events
Number of participants with potentially clinically significant vital sign values.
Measured: Up to Day 576
Number of participants with laboratory value abnormalities and/or adverse events
Number of participants with potentially clinically significant laboratory values.
Measured: Up to Day 576
Safety assessed by Anti-LAMP-1 antibody
Anti-LAMP-1 antibody formation for all participants will be summarized for each treatment by visit using descriptive statistics.
Measured: Up to Day 576
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start12 Mar 2019
- Primary completion11 Oct 2021
- Study completion11 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Senior Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755713
- Sponsor's protocol ID
- 0892-CL-1002
- Status last verified
- Oct 2024
- First submitted
- 26 Nov 2018
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability and Immune Response in Adolescents Allergic to Peanut After Receiving Intradermal Administration of ASP0892 (ARA-LAMP-vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine
- ClinicalTrials.gov ID
- NCT03755713
- Acronym / sponsor ID
- 0892-CL-1002
- Conditions
- Peanut Allergy
- Keywords
- ASP0892, Peanut Allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 11 Oct 2021 (actual)
- Study completion
- 11 Oct 2021 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of ASP0892 after intradermal (ID) injection in adolescent participants with peanut allergy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASP0892 Low Dose (Cohort A) | Experimental | Drug: ASP0892Each cohort will consist of 10 participants (ASP0892 n = 8 and placebo n = 2). The data will be assessed by the Data Monitoring Committee (DMC) after all enrolled cohort A participants complete visits through day 43. Assessments for safety, tolerability, and dose escalation will occur prior to beginning cohort B. |
| ASP0892 High Dose (Cohort B) | Experimental | Drug: ASP0892After all participants in cohort A complete study procedures, the DMC will review the safety and tolerability data and provide recommendations depending on the nature, frequency and severity of the safety profile reviewed. Recommendations will be to proceed with escalation to the next higher dose or stop dose escalation (i.e., no further dosing with study drug). |
| Placebo | Placebo comparator | Drug: PlaceboEach cohort will consist of 10 participants (ASP0892 n = 8 and placebo n = 2). The data will be assessed by the Data Monitoring Committee (DMC) after all enrolled cohort A participants complete visits through day 43. Assessments for safety, tolerability, and dose escalation will occur prior to beginning cohort B. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Subject has a body mass index (BMI) ≥ 3rd percentile and ≤ 97th percentile.
- 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 Immunoglobulin E (IgE) measured by ImmunoCAP > 0.35 kU/L.
- Subject has a positive Skin prick test (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]).
Key exclusion criteria (26 listed)
- 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, per the Grading of Food- Induced Anaphylaxis According to Severity of Clinical Symptoms based on historical clinical symptoms.
- Subject has received or is planning to receive administration of any vaccine (other than injectable Influenza vaccine) from 28 days prior to the first dose through 2 weeks after the last dose of the study vaccine.
- Subject 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 has used the following drug(s) prior to the dosing of the study vaccine:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP0892Intradermal | Drug | ASP0892 High Dose (Cohort B), ASP0892 Low Dose (Cohort A) |
| PlaceboIntradermal; normal saline solution | Drug | Placebo |
Primary outcome
Safety as assessed by Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Day 576
Adverse Events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). AEs starting or worsening after the first dose of study drug up through study completion will be considered treatment-emergent.
Safety as assessed by local reactogenicity reactions
Time frame: Up to Day 50
Participants will be asked to record local reactogenicity (pain, tenderness; erythema/redness, Induration/Swelling) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (Potentially Life Threatening).
Safety as assessed by systemic reactogenicity reactions
Time frame: Up to Day 50
Participants will be asked to record systemic reactogenicity (nausea/vomiting, diarrhea, headache, fatigue, myalgia) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (Potentially Life Threatening).
Number of participants with vital signs abnormalities and/or adverse events
Time frame: Up to Day 576
Number of participants with potentially clinically significant vital sign values.
Number of participants with laboratory value abnormalities and/or adverse events
Time frame: Up to Day 576
Number of participants with potentially clinically significant laboratory values.
Safety assessed by Anti-LAMP-1 antibody
Time frame: Up to Day 576
Anti-LAMP-1 antibody formation for all participants will be summarized for each treatment by visit using descriptive statistics.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Derived from this study: PubMed 38010254Ferslew 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.
- Link to results on the Astellas Clinical Study Results website.Link provided by the sponsor.
- Link to plain language summary of the study on the Trial Results Summaries websiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor, Senior Medical Director study director
Astellas Pharma Global Development, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP0892 in people with Peanut Allergy, run by Astellas Pharma Global Development, Inc. at 7 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 14 inclusion and 26 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 7 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 Treatment Emergent Adverse Events (TEAEs) (time frame: Up to Day 576). The study lists 6 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 NCT03755713, which also lists 1 linked publication.
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.