Eligible patients who develop dose-limiting allergy symptoms after consuming single doses of 300 mg dried egg white protein in a screening double-blind, placebo-controlled food challenge
(DBPCFC) will be randomly assigned 2:1 to blinded treatment with AR201 or placebo.
The primary endpoints are safety of VE416 and amount of peanut protein tolerated during a double-blind, placebo-controlled food challenge
following the treatment.
Importantly, while molecular peptide characteristics of EHFs may suggest hypoallergenicity, these findings need to be assessed by rigorous clinical trials demonstrating tolerance in at least 90% of cow's milk-allergic children by double-blind, placebo-controlled food challenge
, in line with the guidance provided by the American Academy of Pediatrics.
Anna Nowak-Wegrzyn, M.D., Ph.D., from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues randomly assigned 46 patients with wheat allergy to low-dose VWG OIT or placebo after a baseline double-blind, placebo-controlled food challenge
, with biweekly escalation to 1,445 mg of wheat protein (WP).
The primary objective of the trial is to assess whether dupilumab as adjunct to AR101 in a Characterized Oral Desensitization ImmunoTherapy regimen, compared to placebo with AR101 in a CODIT regimen, improves desensitization at the completion of up-dosing, defined as an increase in the proportion of participants who pass a double-blind, placebo-controlled food challenge
with a single-highest tolerated dose of 1,000 mg of peanut protein.
In these subjects, CMPA was diagnosed through positive double-blind, placebo-controlled food challenge
studied the impact of wheat allergy in 179 adults with atopic eczema (128 females, 51 males; average age 26 years), using open exposure and double-blind, placebo-controlled food challenge
tests, as well as specific serum IgE, skin prick, and atopy patch tests.
[3.] Bock SA, Sampson HA, Atkins FM, et al Double-blind, placebo-controlled food challenge
(DBPCFC) as an office procedure: A manual.
Possible cases of food allergy were investigated further with diagnosis made by double-blind, placebo-controlled food challenge
The second part of the study was a five-day double-blind placebo-controlled food challenge
for cow's milk.
The double-blind placebo-controlled food challenge
(DBPCFC) is still the gold standard for the diagnosis of food allergy; all allergy guidelines emphasise its importance and encourage its use.