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=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 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=46 Predicting Peanut Anaphylaxis and Reducing Epinephrine
Anaphylaxis Food
Primary: Anaphylaxis Occurrence Rates in Each Group — 9; 10 Participants — p=0.77
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=23 The Effect of Per Oral Immunotherapy in Severe IgE Mediated Egg, Milk, and Nut Allergy in Adults
Food Allergy
Primary: Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy — 6; 4; 3 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 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
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=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 4 N=12 Pharmacokinetics of Intramuscular Adrenaline in Food--Allergic Teenagers
Anaphylaxis
Primary: Plasma Catecholamine Levels (Maximum Concentration, Cmax) — 218; 394; 290 pg/ml
N/A N=30 Oral Peanut Immunotherapy
Peanut Allergy
Primary: Tolerance or Sustained Unresponsiveness — 2; 7 Participants
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=24 Oral Immunotherapy for Peanut and Mammalian Meat Allergies
Food Hypersensitivity
Primary: The Level of Allergen Consumed Post-oral Immunotherapy — 6; 300 milligrams
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 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
N/A N=20 Immunological Response After Shrimp Oral Immunotherapy Treatment
Allergy to Shrimp · Immunotherapy
Primary: Change in Eliciting Dose of Shrimp During Oral Food Challenge — 3233; 25 mg
Phase 2 N=48 Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients
Food Allergy
Primary: Desensitization Measured by Proportion of Food Allergic (FA) Participants Who Pass a DBPCFC to 2,000 mg Protein for Each of 2 Allergens at Week 36 — 30; 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=77 OIT and Xolair® (Omalizumab) in Cow's Milk Allergy
Milk Allergy
Primary: Percentage of Subjects in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Clinical Tolerance to Milk — 46.4; 34.5 Percent of participants — p=0.42
Phase 2 N=108 Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE)
Hypersensitivity · Food Allergy · Hypersensitivity, Food
Primary: The Success Rates of Passing a Peanut Double-Blind Placebo Controlled Food Challenge (DBPCFC) — 19; 27; 3 Participants — p=0.16
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
Early Phase 1 N=25 Milk Oral Immunotherapy in Children to Treat Food Allergy
Milk Hypersensitivity
Primary: Number of Subjects Who Completed Desensitization Protocol — 6; 12 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 3 N=129 SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study
Eosinophilic Gastrointestinal Disorders (EGIDs) · Eosinophilic Esophagitis (EoE)
Primary: Percent of Participants in Histologic Remission (<15 Eos/Hpf) — 34.3; 40.3 percentage of participants — p=0.58
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…
N/A N=10 Novel Blood Test to Predict Safe Foods for Infants and Toddlers With Food Protein-induced Enterocolitis Syndrome (FPIES)
Food Protein-Induced Enterocolitis Syndrome · Allergies · Pediatric Disorder
Primary: Negative Predictive Value (NPV), Defined as the Percentage of Test-predicted Safe Foods That Are Actually Safe Foods. — 98.5; 73.16 percentage — p=<0.0001
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=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=20 Time-limited Specific Oral Tolerance Induction in Children With Severe Egg Allergy
- Egg Hypersensitivity
Primary: Number of Children That Achieved Total (40 ml) or Partial (Less Than 40 ml But at Least 10 ml) Tolerance to Raw Egg — 9; 0 participants