Clinical Studies Ongoing Studies that are Accepting Referrals

University of Michigan

We are looking for children under age 6 with known peanut allergy and positive testing within the last year who would be willing to do a food challenge. Benefits include negative challenges leading to a cleared allergy status (happens more than one would expect) and an oral immunotherapy consultation during the challenge. The main benefit to the referring allergist is the chance to clear a peanut allergy in a higher risk individual. The patient landing page is https://UMHealthResearch.org/#studies/HUM00205852a>. This study is registered at ct.gov (https://clinicaltrials.gov/study/NCT05696236?term=NCT05696236&rank=1) and governed by the University of Michigan IRB (HUM00205852).

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Assessing safety of COVID-19 mRNA vaccine administration in the setting of a previous adverse reaction

The study inclusion/exclusion criteria are below. We’re approved to start with Pfizer only, but we expect to add Moderna soon via an amendment under consideration. Right now, the study can include only people who need a 2nd vaccine dose. However, we hope to add boosters in the near future.

While not everyone will qualify at this time under the current protocol, we hope to have expansions of the eligible study population in the future. Physicians/Providers can send patient information to allergycovidstudy@med.umich.edu, our shared email.

Study Description:
Eligible participants will be required to complete a pre-vaccination laboratory visit, followed by a vaccination visit at the Frankel Cardiovascular Center, which will be closely monitored by study investigators and staff experienced in the care of allergic reactions.

Inclusion Criteria include:

  • 18 years and older
  • History of adverse reaction to first dose of Pfizer-BioNTech COVID-19 vaccine within the past three months

Exclusion Criteria include:

  • History of antibody or convalescent plasma for treatment or prevention of COVID-19 within 90 days
  • Individuals with severe allergic reaction (e.g. anaphylaxis) to any component of Pfizer-BioNTech COVID-19 vaccination
  • History of underlying immune disorder
  • History of chronic kidney disease (Stage 3 or higher)
  • History of significant pulmonary compromise
  • Pregnancy

The UM Health Research landing page has been activated for prospective subjects at: https://UMHealthResearch.org/#studies/HUM00206480

University of Michigan Food Allergy Trials

  1. ARC005: Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON) Aimmune Therapeutics, Inc.  – Ages 1-3 Years (Inclusive)
  2. A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin® Peanut in Peanut-allergic Young Children 1-3 Years of Age. DBV – Ages 1-3 Years (Inclusive)
  3. R668-ALG-16114: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study In Pediatric Subjects With Peanut Allergy To Evaluate The Efficacy And Safety Of Dupilumab As Adjunct To AR101-Codit (Peanut Oral Immunotherapy) Regeneron Pharmaceuticals, Inc. Ages 6-<18 years old
  4. AIME201. A Phase 2 Study of AR201 Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy. Aimmune Therapeutics. Ages 4-26 years (Inclusive)

PI: Dr. Gigi Sanders
Research Coordinators:
Contact Email: foodallergytrials@med.umich.edu

University of Michigan

  1. BCX7353-204 – ENROLLING (PI: Baptist). An open label safety study of an oral prophylactic to prevent Hereditary Angioedema (HAE) attacks in patients 12 years of age and older with Type I and Type II HAE. Sponsor: Biocryst
  2. SHP643-303 – ENROLLING (PI: Baptist). A randomized, placebo-controlled, double-blind study to determine the safety and efficacy of lanadelumab for preventing acute attacks in patients 18 years of age and older with non-histaminergic angioedema with normal C1-Inhibitor (C1-INH) and acquired angioedema (AAE) due to C1-INH deficiency. Sponsor: Takeda
  3. EMPOWER – ENROLLING (PI: Baptist) A 36-month observational study of patients with HAE. Sponsor: Takeda
  4. MANDALA (AV003) – ENROLLING (PI: Baptist). A randomized clinical trial to understand the safety and efficacy of two doses of a budesonide-albuterol rescue inhaler compared to albuterol rescue inhaler in patients 4 years of age and older with uncontrolled asthma. Sponsor: Syneos Health
  5. Improving Medication Adherence with Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults with Asthma (MATCH) – ENROLLING (PI: Baptist). Sponsor: American Lung Association
  6. CHRONICLE – ENROLLING (PI: Baptist). An observational study of patients with severe asthma who do not achieve control with high-dose ICS therapy with additional controllers and/or require systemic corticosteroid or monoclonal antibody therapy. Sponsor: Novartis.

PI: Dr. Alan Baptist

University of Michigan

  1. A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24 week Phase 3 Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES) (PI: Dr. Anna Kovalszki). Patients 12 years of age and up (no upper age limit). Sponsor: Astra-Zeneca
  2. PIONEER: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Avapritinib in Patients With Indolent or Smoldering Systemic Mastocytosis (PI: Dr. Cem Akin). Age 18 and up. Sponsor: Blueprint Medicines