Table 1. Ongoing studies of novel... | Rockefeller University Press

Table 1.

Ongoing studies of novel therapeutics in food allergy

Identifier	Therapeutic	Target	n	Description
NCT03881696	Omalizumab + multi-food OIT	IgE	225	RDBPC study examining omalizumab as a monotherapy, and as an adjunct to multi-food OIT in peanut (+ 2 foods) allergic participants. 1° outcome is the percentage of subjects who pass a 600 mg DBPCPC at 16–20 wk.
NCT04984876	Ligelizumab	IgE	486	52-wk phase 3 study RDBPC trial. 1° outcome is the percentage of subjects who pass a 600 mg DBPCPC challenge at wk 12.
NCT03793608	Dupilumab	IL-4/IL-13 receptors	25	24 wk open label study. 1° outcome is the percentage of participants passing a DPBCPC of 444 mg or greater.
NCT03682770	Dupilumab + AR101	IL-4/IL-13 receptors	149	RDBPC study to evaluate the efficacy of dupilumab as an adjunct therapy to AR101 (peanut OIT). 1° outcome is the percentage of participants who pass a 2044 mg DBPCPC.
NCT05069831	Abrocitinib	Cytokines signaling through JAK1	40	A double-blind randomized study testing 100 and 200 mg of abrocitinib for 16 wk. 1° outcome is change in peanut-induced basophil activation from baseline to 16 wk.
NCT02960074	FMT	Microbiota	15	1 yr two-arm study of FMT (n = 10, phase I) or antibiotics + FMT (n = 5, phase II). 1° outcome is FMT-related adverse events grade 2 or higher. 2° endpoints include change in threshold of peanut reactivity during a DBPCPC.
NCT03936998	VE416 + peanut OIT	Microbiota	60	RDBPC study to evaluate the impact of a microbial cocktail (VE416) with or without vancomycin on peanut OIT. 1° outcome (phase 1) is number of participants with treatment-related adverse events; 1° outcome (phase 2) is maximum tolerated dose of peanut during a DBPCPC.
NCT04872218	Abatacept + peanut OIT	CTLA-4	14	RDBPC study comparing 24 wk of abatacept vs. placebo with OIT. 1° outcome is peanut-specific IgE at wk 24. 2° endpoints include threshold dose, and sustained unresponsiveness at 36 wk.

Identifier	Therapeutic	Target	n	Description
NCT03881696	Omalizumab + multi-food OIT	IgE	225	RDBPC study examining omalizumab as a monotherapy, and as an adjunct to multi-food OIT in peanut (+ 2 foods) allergic participants. 1° outcome is the percentage of subjects who pass a 600 mg DBPCPC at 16–20 wk.
NCT04984876	Ligelizumab	IgE	486	52-wk phase 3 study RDBPC trial. 1° outcome is the percentage of subjects who pass a 600 mg DBPCPC challenge at wk 12.
NCT03793608	Dupilumab	IL-4/IL-13 receptors	25	24 wk open label study. 1° outcome is the percentage of participants passing a DPBCPC of 444 mg or greater.
NCT03682770	Dupilumab + AR101	IL-4/IL-13 receptors	149	RDBPC study to evaluate the efficacy of dupilumab as an adjunct therapy to AR101 (peanut OIT). 1° outcome is the percentage of participants who pass a 2044 mg DBPCPC.
NCT05069831	Abrocitinib	Cytokines signaling through JAK1	40	A double-blind randomized study testing 100 and 200 mg of abrocitinib for 16 wk. 1° outcome is change in peanut-induced basophil activation from baseline to 16 wk.
NCT02960074	FMT	Microbiota	15	1 yr two-arm study of FMT (n = 10, phase I) or antibiotics + FMT (n = 5, phase II). 1° outcome is FMT-related adverse events grade 2 or higher. 2° endpoints include change in threshold of peanut reactivity during a DBPCPC.
NCT03936998	VE416 + peanut OIT	Microbiota	60	RDBPC study to evaluate the impact of a microbial cocktail (VE416) with or without vancomycin on peanut OIT. 1° outcome (phase 1) is number of participants with treatment-related adverse events; 1° outcome (phase 2) is maximum tolerated dose of peanut during a DBPCPC.
NCT04872218	Abatacept + peanut OIT	CTLA-4	14	RDBPC study comparing 24 wk of abatacept vs. placebo with OIT. 1° outcome is peanut-specific IgE at wk 24. 2° endpoints include threshold dose, and sustained unresponsiveness at 36 wk.

RDBPC, randomized double-blind placebo-controlled; DBPCPC, double-blind placebo-controlled peanut challenge.