Welcome to the ACAAI Clinical Trial Resource page. While the ACAAI does not endorse these trials, we do encourage clinicians and their patients to partake in this valuable resource. Without these clinical trials, medical advancements would be greatly hindered.
To obtain information on how to participage in a clinical trial, please browse the trial opportunities below.
LOU064 Food allergy study
Novartis
A study of a month-long treatment to examine the efficacy and safety of remibrutinib (LOU064), a BTK inhibitor, in patients with peanut allergy. The primary endpoint is evaluated by the ability to tolerate 600 mg of peanut protein. Participating sites are open in the USA, Spain and Italy.
Eligible patients – Adults aged 18-55 with IgE-mediated peanut allergy.
For more information, see clinicaltrials.gov and Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts
Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Genentech, Inc.; Novartis Pharmaceuticals
This study is a multi-center, randomized, double-blind, placebo-controlled study in participants 1 to less than 56 years of age who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew, hazelnut, or walnut). While each participant may be allergic to more than two other foods, the primary endpoint/outcome in this study will only be assessed in peanut and two other foods for each participant. The primary objective of the study is to compare the ability to consume foods without dose-limiting symptoms during a double-blind placebo-controlled food challenge (DBPCFC), after treatment with either omalizumab or placebo for omalizumab.
Selected key inclusion criteria:- Age 1-55 years, with signed informed consent and/or assent
- Allergic to peanut and at least 2 of the following foods based on DBPCFC: milk, egg, wheat, cashew, hazelnut, walnut
- Eligibility for omalizumab dosing, according to the study drug-dosing table
Selected key exclusion criteria:
- Dose-limiting symptoms to the placebo portion of the screening DBPCFC
- Sensitivity or suspected/known allergy to omalizumab
- Poorly controlled atopic dermatitis at screening
- Poorly controlled or severe asthma/wheezing at screening
- History of severe anaphylaxis to participant-specific foods used in this study