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 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=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=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=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 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
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 3 N=175 ARTEMIS Peanut Allergy In Children
Peanut Allergy
Primary: The Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Oral Food Challenge. — 77; 1 Participants — p=<0.0001
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 4 N=20 Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens
Atopic Dermatitis
Primary: Change in Percentage of Body Involvement — -2.0; 0.15 Change of percentage in body involvement
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=146 Peanut Oral Immunotherapy in Children
Peanut Hypersensitivity
Primary: Percentage of Participants Desensitized to Peanut Protein After 134 Weeks of Oral Immunotherapy (OIT) — 71; 2 Percentage of Participants — p=<0.0001
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…
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=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=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
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
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=60 A Study of Sublingual Immunotherapy in Peanut-allergic Children
Food Hypersensitivity
Primary: Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing — 45.5; 0; 11.8; 66.7 percentage of participants
Phase 2 N=51 Promoting Tolerance to Common Allergens in High-Risk Children: Global Prevention of Asthma in Children (GPAC) Study
Asthma · Allergic Sensitization
Primary: Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion — 22; 19 participants — p=0.28
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
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 The Psychosocial Outcomes in Caregivers of Children With Food Allergy
Food Allergy in Children · Caregiver Burnout · Psychosocial Problem
Primary: Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System Fatigue Short Form: PROMIS Short Form 6a — 50.6; 53 score on a scale
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 3 N=413 Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
Peanut Allergy
Primary: Percentage of Treatment Responders at Month 12 — 67.0; 33.5; 52.4; 70.0 Percentage of participants — p=<0.001
Phase 4 N=102 Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents
Dermatitis, Contact
Primary: Positive Reactions: Nickel Sulfate — 30 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=92 Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy
Food Allergy
Primary: Sustained Unresponsiveness to Egg Consumption at 2 Years. — 3; 10; 7 Participants — p=0.009
Phase 2 N=640 Promoting Tolerance to Peanut in High-Risk Children
Eczema · Egg Allergy · Food Allergy
Primary: Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum — 36; 5; 18; 5 Participants — p=<0.0001
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