Upcoming/Enrolling Studies
1. 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.
Eligible Participants
- Ages 12-55 (plans to add ages 6-11 in the future)
- History of peanut allergy
Sponsor: Novartis
PI: Georgiana Sanders, MD
Current Status: Enrolling
2. 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.
Eligible Participants
- Neonates (<7 days of age) with family history of allergic disease
Sponsor: Siolta Therapeutics
PI: Georgiana Sanders, 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
- Patient of University of Michigan Allergy undergoing an oral food challenge
Sponsor: M-FARA, FARE Discovery Center of Distinction award, NIH/NIAID K23
PI: Charles Schuler IV, MD
Current Status: Enrolling
7. 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.
Eligible Participants
- Ages 6 months-5 years.
- History of Peanut allergy
Sponsor: Gerber Foundation
PI: Charles Schuler IV, MD
Current Status: Upcoming
8. COUR Peanut Infusion Study (CNP-201): This study is testing the safety of an intravenous (IV) drug to treat peanut allergy. A phase 1 study to evaluate the safety of a peanut-containing nanoparticle infusion for potential treatment of peanut allergy
Eligible Participants
- Ages 16-55
- History of peanut allergy
Sponsor: COUR Pharmaceuticals
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 study of a peanut skin patch as a new treatment for peanut allergy. A phase 3 clinical trial to assess the clinical benefit of Viaskin Peanut patch and evaluate safety of long-term treatment after up to 3 years of epicutaneous immunotherapy to induce/maintain desensitization to peanut in peanut-allergic children.
Sponsor: DBV Technologies
PI: Georgiana Sanders, MD
Current Status: Ongoing (closed to enrollment)
3. ARC008 (Palforzia® Study): A long-term safety extension study for eligible subjects who have participated in a previous Aimmune AR101 (Palforzia®) clinical study.
Sponsor: Aimmune Therapeutics
PI: Georgiana Sanders, MD
Current Status: Ongoing (closed to enrollment)