Food Allergy Clinical Trials

Infant being examined in food allergy clinic

Patients as partners

Researchers and clinicians at the Mary H. Weiser Food Allergy Center are leading or co-leading a number of clinical trials related to food allergy discovery and treatment.

Upcoming/Enrolling Studies

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. [HUM00235532]

For more information, visit U-M Health Research Study page 

PI: Charles Schuler IV, MD
 

MY-CLN-SP-006-PA1001 – Part B

A Phase I Randomized, Quadruple-blinded, Placebo-controlled, Single-ascending and Multiple Dose Study to Evaluate the Safety, Local Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Exploratory Clinical Activity of MY006 in Healthy Volunteers and Adolescent and Adult Patients with Peanut Allergy [HUM00286332]

PI: Ian Slack, MD

For more information, visit U-M Health Research Study page 

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. [HUM00165471]


PI: Charles Schuler IV, MD

AL-60 Study

The purpose of this post-market 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. [HUM00259595] 

PI: Ian Slack, MD

For more information, visit U-M Health Research Study page 

Neffy/ EPI R01

A Phase IV Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients with allergic reactions after Oral Food Challenge or Allergen Immunotherapy (EPI R01) [HUM00272780]

PI: Ian Slack, MD

U44-MNLT-01

Phase I Safety Study of MOON101 for the Treatment of Peanut Allergy [HUM00279902]

PI: Ian Slack, MD

For more information, visit U-M Health Research Study page 

CLOU064I12301

A 52-week multicenter, randomized, double-blind, placebo-controlled Phase 3 study to assess efficacy and safety of remibrutinib (LOU064) in adult and adolescent participants with IgE-mediated food allergy [HUM00278418]

PI: Ian Slack, MD

Zenith/ITN097AD

Efficacy of Tezepelumab in Peanut Oral Immunotherapy: a Double-Blind, Randomized, Placebo-Controlled Phase 2 Trial [HUM00271618]

PI: Ian Slack, MD

SAFER/CoFAR15

Study of Oral Food Challenge Biomarkers [HUM00287633]

PI: James Baker Jr., MD

Ongoing Studies

Vitesse

Phase 3 trial in peanut-allergic children ages 4 – 7 is a 12-month study evaluating the efficacy and safety of the Viaskin Peanut Patch in more than 600 subjects worldwide. [HUM00229249]

PI: Kelly O’Shea, MD

COMFORT/ V712-308

A Phase 3, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Safety of Epicutaneous Immunotherapy with DBV712 250 µg in 1-through 3-year-old Children with Peanut Allergy [HUM00275174]

PI: Ian Slack, MD

Phase 2B

Phase 2B Randomized, Double-Blind, Placebo-Controlled Study of RPT904 as Monotherapy in Participants with IGE-mediated Food Allergy [HUM00283688]

PI: Ian Slack, MD