Phase 2 N=10 Preventing Anaphylaxis With Acalabrutinib
Food Allergy · Food Allergy Peanut
Primary: Highest Dose of Peanut That is Tolerated During Oral Food Challenge — 29; 4,044 mg — p=0.002
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Phase 2 N=16 A Randomized, Double-Blind, Placebo-Controlled Study of Omalizumab for Idiopathic Anaphylaxis
Anaphylaxis · Hypotension · Bronchospasm
Primary: Reduction in the Number and Timing of Anaphylactic Events in Subjects With a History of Frequent Idiopathic Anaphylaxis. — 32; 6 percentage of change of events
N/A N=46 Predicting Peanut Anaphylaxis and Reducing Epinephrine
Anaphylaxis Food
Primary: Anaphylaxis Occurrence Rates in Each Group — 9; 10 Participants — p=0.77
Phase 2 N=75 Peanut Epicutaneous Phase II Immunotherapy Clinical Trial
Peanut Hypersensitivity · Food Hypersensitivity · Hypersensitivity
Primary: Percentage of Subjects With a Successful Treatment Response — 12.0; 45.8; 48.0 percentage of participants — p=0.005
Phase 4 N=12 Pharmacokinetics of Intramuscular Adrenaline in Food--Allergic Teenagers
Anaphylaxis
Primary: Plasma Catecholamine Levels (Maximum Concentration, Cmax) — 218; 394; 290 pg/ml
Phase 2 N=6 Inhibition of Anaphylaxis by Ibrutinib
Food Allergy · Anaphylaxis Food
Primary: Number of Doses of Ibrutinib for Maximal Suppression of Skin Prick Test Size to Foods — 2 doses — p=<0.0001
N/A N=1,425 The Effect of Antihypertensive Drugs on Severity of Anaphylaxis and Side-effects During Venom Immunotherapy
Hymenoptera Venom Allergy · Antihypertensive Treatment
Primary: Frequency of Side Effects (=Systemic Reaction, SR) During Venom Immunotherapy (VIT) — 19; 74 Participants — p=0.25
Phase 2 N=686 COVID19 SARS Vaccinations: Systemic Allergic Reactions to SARS-CoV-2 Vaccinations
SARS-CoV Infection · COVID-19 · Allergic Reaction
Primary: Proportion of Participants Who Experienced a Systemic Allergic Reaction (CoFAR Grade 2+ Regardless of Tryptase or CoFAR Grade 1 With Elevated Tryptase) Within 90 Minutes…
Phase 2 N=14 Omalizumab in the Treatment of Peanut Allergy
Food Allergy · Peanut Allergy
Primary: Number of Participants Who Experienced a Decrease in Pn-BHR Area Under the Curve (AUC) of > 80% Compared With Baseline Values Before Week 8 — 5; 9 Participants
Phase 3 N=180 Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants
Peanut Allergy · Multi-food Allergy
Primary: Number of Participants by Stage 1 Treatment Assignment, Omalizumab Versus Placebo, Who Successfully Consume a Single Dose of ≥600 mg of Peanut Protein Without…
N/A N=30 Oral Peanut Immunotherapy
Peanut Allergy
Primary: Tolerance or Sustained Unresponsiveness — 2; 7 Participants
Phase 2 N=36 Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial
Peanut Allergy · Food Allergy
Primary: Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo — 23; 1 Participants
Phase 1 N=15 Peanut Oral Immunotherapy in Children With Peanut Allergy (Peanut Flour)
Peanut Allergic Subjects
Primary: Determine the Percentage of Patients Tolerating the 12-month DBPCFC — 2; 10 Participants
N/A N=118 Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing
Allergic Asthma
Primary: Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants — 24; 2; 1; 1 participants
Phase 2 N=37 Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study
Food Hypersensitivity
Primary: Determine the Percentage of Subjects Who Demonstrate Sustained Unresponsiveness (SU) by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC). — 29…
Phase 2 N=60 Multi Immunotherapy to Test Tolerance and Xolair
Food Allergy
Primary: The Number of Participants Able to Tolerate an Oral Food Challenge to 2,000 mg at Least of 2 Allergens at Week 36 (i.e. the End of the Randomized Withdrawal/Tolerance…
Phase 2 N=13 Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy
Peanut Hypersensitivity
Primary: The Percentage of Subjects Who Pass the 20gm Peanut Flour (~50% Peanut Protein) Oral Food Challenge 2-4 Weeks After Discontinuing Peanut OIT Therapy — 3; 1 Participants
Phase 2 N=73 ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults
Food Allergy
Primary: 600mg Desensitization in at Least One Qualifying Food — 8; 11; 4 Participants
Phase 2 N=25 Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
Peanut Allergy
Primary: Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 24 — 8.3 Percentage of Participants
Phase 2 N=20 Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Peanut Allergy
Peanut Allergy
Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 15; 5; 0; 0 Participants
N/A N=30 The Effect of Per Oral Immunotherapy in Severe Milk, Peanut and Egg Allergy in Adults
Food Allergy
Primary: Desensitisation — 7; 5; 2 Participants
Phase 3 N=33 Pilot Phase III Clinical Trial of JDP-205 IV Injection for Treatment of Acute Urticaria
Acute Urticaria
Primary: Extent of Urticaria/Erythema Score (Physician Assessment) — 1.91; 1.74; 1.53; 1.12 units on a scale
Phase 2 N=54 Sublingual Immunotherapy for Peanut Allergy and Induction of Tolerance
Peanut Hypersensitivity · Food Hypersensitivity · Food Allergy
Primary: Population Sensitization Threshold in mg Peanut Protein Predicted to Provoke Reactions in 5% of the Peanut-allergic Population — 160; 300 mg
N/A N=31 Safe Administration of Flu Vaccine to Egg Allergic Children
Egg Allergy
Primary: Categorical Reactivity to Vaccine as it Was Administered — 17; 14; 3; 4 Participants
Phase 2 N=16 Oral Immunotherapy (OIT) for Peanut Allergy
Peanut Hypersensitivity
Primary: Percentage of Subjects Achieving Tolerance as Defined by a Negative DBPCFC 4 Weeks After Discontinuation of Peanut OIT Therapy. — 89 percentage of participants
Phase 2 N=253 Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)
Allergic Skin Reaction
Primary: Positive Allergic Reaction to Amphadase® in the Per-Protocol Population (PPP) — 0 participants
Phase 3 N=30 The Safety and Efficacy of Intralymphatic Immunotherapy in Pollen Allergic Adolescents and Young Adults With Asthma
Rhinitis · Asthma · Allergy
Primary: Change in Symptoms Score After Nasal Allergen Challenge — -5; -4; -1 score on a scale
Phase 2 N=13 Xolair Enhances Oral Desensitization in Peanut Allergic Patients
Peanut Allergy
Primary: Number of Participants That Tolerated Rapid Oral Peanut Desensitization to a Dose of 500 mg Peanut Flour (Cumulative Dose, 1,000 mg) — 13 participants
Phase 3 N=555 Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
Peanut Allergy
Primary: Percentage of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) — 250; 5…
Phase 4 N=10 Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy
Idiopathic Angioedema
Primary: Mean 7-day Angioedema Activity Score (AAS7) — 2.8; 1.6; 0.69; 0.20 score on a scale