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.