The active vs. cytokine production. RESULTS Effectiveness measurements for active vs. placebo participants at the day 15 and 45 food challenge (tolerating a cumulative 275 mg of peanut protein, which was the food AZ304 challenge outcome defined with this paper) shown, respectively, 73% vs. 0% (= 0.008) to 57% vs. 0% (ns). The etokimab group experienced fewer adverse events compared with placebo. IL-4, IL-5, IL-9, IL-13, and ST2 levels in CD4+ T cells were reduced in the active vs. placebo arm upon peanut-induced T cell activation (= 0.036 for IL-13 and IL-9 at day time 15), and peanut-specific IgE was reduced in active vs. placebo (= 0.014 at day time 15). Summary The phase 2a results suggest etokimab is safe and well tolerated and that a solitary dose of etokimab could have the potential to desensitize peanut-allergic participants and possibly reduce atopy-related adverse events. TRIAL Sign up ClinicalTrials.gov “type”:”clinical-trial”,”attrs”:”text”:”NCT02920021″,”term_id”:”NCT02920021″NCT02920021. FUNDING This work was supported by NIH grant R01AI140134, AnaptysBio, the Hartman Vaccine Account, and the AZ304 Sean N. Parker Center for Allergy and Asthma Study at Stanford University or college. = 15) and placebo (= 5) group, respectively. A total of 80% of participants from the active organizations and 100% of participants from placebo group experienced at least a second Itga2 atopic condition. Open in a separate window Number 1 Participant enrollment consort diagram.EKG, electrocardiogram; SPT; pores and skin prick checks. Asterisk indicates completed OFC. Open in a separate window Number 2 Study Design.OFC, oral food challenges; PK, pharmacokinetics; WBC, white blood cell count. Table 1 Patient demographics Open in a separate windows AEs. Treatment emergent AEs (TEAE) are summarized in Table 2 and Table 3. The most frequent AE reported in etokimab-dosed participants was headache in 4 of 15 participants (26.7%). In placebo-dosed participants, the most frequent AEs were atopy-related events (asthma, eczema, food allergy, and sensitive rhinitis) in 3 of 5 participants (60%). Atopy-related events were observed in only 1 1 of 15 participants (7%) in the etokimab-dosed group. Compared with the placebo group, the participants in the active treatment arm experienced fewer moderate AEs (etokimab vs. placebo; 60% vs. 100%, respectively). Etokimab was generally well tolerated during the study. No severe AEs (defined by predefined protocol and Common Terminology Criteria for Adverse Events [CTCAE]) were reported. Table 3 Treatment emergent adverse events by severity up to day time 45. Open in a separate window Table 2 Treatment emergent adverse events up to day time 45. Open in a separate window Food difficulties. At baseline, all 20 participants (both the active and placebo group) met eligibility, which included reacting to standardized OFC, where a reaction was defined as an objective reaction to less than 275 mg peanut protein. All standardized OFC results were examined by an independent, blinded expert reviewer. In the active group, 11 of 15 (73%), and 4 of 7 (57%) participants approved the OFC at day time 15 and day time 45, respectively. Those who reached the 275 mg threshold at day time 45 experienced also reached this threshold at day time 15. None of them of the placebo participants approved the OFC at day time 15 or at day time 45. However, since day time 45 was part of the follow-up phase, only a few participants returned to try to total the day 45 food challenge. Results indicate a significant increase in desensitization to peanut protein after a single i.v. administration of etokimab for the active group (Number 3A; = 0.008). We also compared the proportions of participants who passed the food challenge to a CTD of 375 mg. For participants in the active group, 47% on day time 15 and 29% on day time 45 passed the food challenge of cumulative 375 mg. Those who reached the AZ304 375 mg threshold at day time 45 experienced also reached this threshold at day time 15. (Number 3B). In addition, participants from the active group had a significant increase of median CTD on day time 15 from baseline (275 mg vs. 175 mg, = 0.001). There was no switch for median CTD on day time 45 compared with day time 15 for active participants who underwent the food challenge on day time 45 (275 mg vs. 275 mg) (Number 3C). Furthermore, there was no significant switch of median CTD from baseline (25 mg) to day time 15 (75 mg) in the placebo group (= 0.63). Open in a separate window Number 3 Oral food challenges.(A) Quantity of participants who.