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
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Phase 2 N=20 A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy
Milk Hypersensitivity
Primary: The Median Milk Threshold Dose Inducing a Reaction — 40; 40; 5100; 0 miligrams
Phase 2 N=170 Study of Milk Allergy and Tolerance in Children
Food Hypersensitivity · Milk Hypersensitivity
Primary: Number of Participants With a Positive Progression in Tolerance of Baked Milk and Ultimately Unheated Milk in Dose Escalation Sub-arm Compared to Maintenance Sub-arm…
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=30 The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy
Milk Allergy
Primary: Change in CM-specific Immunogloblin E (IgE) — 0.8; -13.5; -9.4 kUa/L
N/A N=40 Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy
Cow's Milk Allergy
Primary: Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula — 0; 0; 0; 30 Participants
Phase 2 N=30 Baked Milk Oral Immunotherapy for Cow's Milk Allergy
Cow's Milk Allergy
Primary: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 — 15; 11 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 2 N=198 Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy
Food Allergy
Primary: Percentage (%) of Subjects Who Are Treatment Responders After 12 Months of EPIT Treatment. — 36.7; 49.0; 36.2; 30.2 percent of participants
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
Phase 2 N=20 Milk Patch for Eosinophilic Esophagitis
Eosinophilic Esophagitis · Milk Allergy
Primary: Change in Maximum Esophageal Eosinophil Count From Baseline to End of Double-blind Treatment. (Intent to Treat Population) — -10.8; -24.2 Eosinophils (Eos)/high power…
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=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 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=10 Oral Immunotherapy for Peanut Allergy (PMIT)
Food Hypersensitivity
Primary: The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing…
Phase 2 N=55 Oral Immunotherapy for Childhood Egg Allergy
Hypersensitivity · Immediate Hypersensitivity · Food Hypersensitivity
Primary: Percent of Participants Who Successfully Consumed 10,000 mg of Egg White Solid Followed by Open Feeding of Egg — 27.5; 0 percentage of participants — p=0.025
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…
Phase 2 N=58 Allergy Immunotherapy for the Reduction of Asthma
Wheezing · Asthma · Allergy
Primary: Asthma Severity as Measured by the Asthma Severity Score (Averaged up to 36 Months) — 21.95; 25.68; 27.72; 27.85 score on a scale — p=0.38
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 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…
N/A N=18 Immune Dysfunction in Allergic Asthma
Asthma
Primary: Anti-KLH Antibody. This is Measured by ELISA and Expressed as ELISA Units Which Are Derived by Dilution of Serum Samples Until the Result Falls on a Linear Portion of…
N/A N=30 Oral Peanut Immunotherapy
Peanut Allergy
Primary: Tolerance or Sustained Unresponsiveness — 2; 7 Participants
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
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
N/A N=13 Treatment of Egg Allergy in Children Through Oral Desensitization (EGG OIT)
Food Hypersensitivity
Primary: Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg — 9 subjects with no symptoms on DBPCFC
Phase 2 N=12 Subcutaneous Immunotherapy for Mouse in Adults
Asthma · Perennial Allergic Rhinitis
Primary: Number of Reported Adverse Events (AEs) — 9; 1; 1; 2 Events
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
N/A N=19 Mast Cell Activation Test in Allergic Disease
Asthma · Mastocytosis · Mast Cell Activation Syndrome
Primary: Mast Cell Activation Test Results for Validation Group — 6; 2; 0; 4 Participants
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
N/A N=22 Cold Milk for Dysphagia in Preterm Infants
Dysphagia of Newborn
Primary: Percentage of Infants With Improvement of Dysphagia — 58 Percentage of patients