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    The study has been updated to version v2.10.0 and now includes 7 locations, replacing the previous version v2.9.7.
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    Summary
    The value 'Show more Revision: v2.9.0' has been updated to 'MedlinePlus related topics: Allergy FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Masking : Double ( Participant Investigator ) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : ASP0892 Low Dose (Cohort A) 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. Drug : ASP0892 Intradermal Experimental : ASP0892 High Dose (Cohort B) 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). Drug : ASP0892 Intradermal Placebo Comparator : Placebo 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. Drug : Placebo Intradermal; normal saline solution Primary Outcome Measures Outcome Measure Measure Description Time Frame 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. 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). 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). 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. Up to Day 576 Number of participants with laboratory value abnormalities and/or adverse events Number of participants with potentially clinically significant laboratory values. 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. Up to Day 576 Keywords Provided by Astellas Pharma Inc (Astellas Pharma Global Development, Inc.) ASP0892 Peanut Allergy Additional Relevant MeSH Terms Hypersensitivity Immune System Diseases Nut and Peanut Hypersensitivity Food Hypersensitivity Hypersensitivity, Immediate Peanut Hypersensitivity Plan to Share Individual Participant Data (IPD)? No IPD 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 ww.clinicalstudydatarequest.com under 'Sponsor Specific Details for Astellas.' Studies a U.S. FDA-Regulated Drug Product Yes Studies a U.S. FDA-Regulated Device Product No Helpful Links Provided by Astellas Pharma Inc (Astellas Pharma Global Development, Inc.) Link to results on the Astellas Clinical Study Results website. Link to plain language summary of the study on the Trial Results Summaries website Revision: v2.9.1'
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