Upcoming/Enrolling Studies
1. Michigan Food and Atopic Dermatitis (M-FAD) Program – Molecular Analytics Project: This study will explore potential links between atopic dermatitis and food allergy to determine unique biochemical or genetic identifiers useful for diagnosing and treatments in the future.
Eligible Participants
- Ages 10-55
- Current diagnosis of food allergy with a history of food anaphylaxis and/or Current diagnosis of Atopic dermatitis
https://UMHealthResearch.org/studies/HUM00235532
Sponsor: Private donor, NIH
PI: Charles Schuler IV, MD
Current Status: Enrolling
2. Alliance Study: This clinical research study will investigate the safety and effect of a peanut immunotherapy tablet in adults, teenagers and children with a peanut allergy.
Eligible Participants
- Ages 4-17 (adult recruitment has closed)
- History of diagnosed peanut allergy
https://UMHealthResearch.org/studies/HUM00240472
Sponsor: ALK
PI: Ian Slack, MD
Current Status: Enrolling
3. FAB Study (Food Allergy Biomarkers Study): A study to identify biomarkers and investigate mechanisms of food anaphylaxis. An observational and bio-sampling study of patients undergoing oral food challenges during routine clinical care or on research protocols for clinical trials.
Eligible Participants
- Patients of University of Michigan Allergy undergoing a clinical oral food challenge
Sponsor: M-FARA, FARE Discovery Center of Distinction award, NIH/NIAID K23
PI: Charles Schuler IV, MD
Current Status: Enrolling
7. AL-60 Study: The purpose of this study is to certify that an extensively broken-down milk protein based infant formula is hypoallergenic (designed to reduce or minimize the possibility of an allergic reaction) in infants and children with a confirmed cow’s milk allergy (CMA) according to the standards published by the American Academy of Pediatrics (AAP).
Sponsor: Abbott
PI: Ian Slack, MD
Current Status: Upcoming
Ongoing Studies
1. HARMONY Study (Multifood OIT allergy study) ADP101: This study is evaluating multifood oral immunotherapy as a treatment for food allergy. A phase 1/2 clinical trial evaluating an oral formulation of 15 individual food sources (ADP101) that are responsible for approximately 90% of food allergies in the United States to be used as an oral immunotherapy (OIT) for the mitigation of allergic reactions. The study has now transitioned to ENCORE Study (open-label extension study) to investigate long-term safety, tolerability, and efficacy of orally administered ADP101.
Sponsor: Alladapt
PI: Ian Slack, MD
Current Status: Ongoing (closed to enrollment)
2. EPITOPE/EPOPEX Study (Peanut Patch Study): A phase 3 clinical trial to assess the clinical benefit of Viaskin Peanut patch and evaluate safety of long-term treatment of epicutaneous immunotherapy to induce/maintain desensitization to peanut in peanut-allergic children.
Sponsor: DBV Technologies
PI: Kelly O’Shea, MD
Current Status: Ongoing (closed to enrollment)
3. PREPARE Study (Predicting Peanut Anaphylaxis and Reducing Epinephrine): This study will investigate water loss across the skin as a marker for severe allergic reactions during oral food challenges. An observational study to evaluate a noninvasive biomarker, transepidermal water loss (TEWL), during oral food challenges to predict anaphylaxis before it is otherwise clinically apparent.
Sponsor: Gerber Foundation
PI: Charles Schuler IV, MD
Current Status: Undergoing data analysis
4. ADORED Study (Allergic Disease Onset Prevention Study) STMC-103H-102: This study is evaluating whether a daily probiotic by mouth can prevent the development of allergies. A phase 1b/2 study to evaluate the safety and efficacy of a probiotic (STMC-103H) in neonates and infants to prevent the development of allergic disease.
Sponsor: Siolta Therapeutics
PI: Georgiana Sanders, MD
Current Status: Ongoing (closed to enrollment)
5. Efficacy and Safety of QGE31 (Ligelizumab) in Patients with Peanut Allergy: This study is testing a new injectable drug for food allergy. A phase 3 clinical trial to evaluate the safety and clinical efficacy of ligelizumab (anti-IgE) on peanut reaction threshold in peanut-allergic individuals.
Sponsor: Novartis
PI: Georgiana Sanders, MD
Current Status: Ongoing (closed to enrollment)
6. Study of Remibrutinib (LOU064) in Patients with Peanut Allergy: The purpose of the study is to assess if remibrutinib can provide protection against allergic reactions to increasing doses of peanut protein as measured by oral food challenge.
Sponsor: Novartis
PI: Kelly O’Shea, MD
Current Status: Ongoing (closed to enrollment)