Trial Outcomes & Findings for Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Peanut Allergy (NCT NCT02920021)

This study was conducted at two clinical sites in the United States between January, 2017 and March, 2018. Inclusion criteria included adult (older than 18 years) male or female participants with a clinical diagnosis of peanut allergy confirmed by an oral food challenge (OFC) at the screening visit (at 7-14 days before treatment).

On Day 1 eligible participants were randomized in a 3:1 ratio to receive one dose of either etokimab or placebo.

Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Peanut Allergy

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. AEs include any clinical laboratory test results determined to be clinically significant by the investigator. AE was considered "serious" if there was any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. Each AE was evaluated for severity (mild, moderate, or severe) and causal relationship to the study drug. AE was considered TEAE if the date of onset was during or after first dose of study treatment, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.

Oral food challenges were performed at Baseline and Day 14 in accordance with the Practical Allergy (PRACTALL) consensus report. Escalating doses of peanut protein (peanut flour mixed with a non-allergic food vehicle such as apple sauce) consisting of 5, 20, 50, 100, 100, 100, and 125 mg (for a cumulative maximum dose of 500 mg) were given at 20 minute intervals. If the participant developed any signs of an objective allergic reaction, the challenge was stopped. The total cumulative tolerated dose of blinded peanut reached prior to reaction was recorded.

Oral food challenges were performed at Baseline and Day 14 in accordance with the PRACTALL consensus report. During OFC the OFC Symptom Scoring Assessment Tool was used to assess participants for common symptoms that can be suspected to be an allergic reaction involving the skin, upper respiratory, lower respiratory, gastrointestinal, and cardiovascular systems. Each symptom was scored according to the following scale: Grade 0 = sign or symptom not observed; Grade 1 = mild; Grade 2 = moderate, Grade 3 = severe. The score from each symptom was averaged to calculate the overall score at Baseline and on Day 14.

The concentration of etokimab was measured using a validated assay method. The lower limit of quantification (LLOQ) was 0.400 microgram per milliliter (μg/mL).

The concentration of etokimab was measured using a validated assay method. The lower limit of quantification (LLOQ) was 0.400 μg/mL.

Area under the concentration-time curve in serum from time zero (predose) extrapolated to infinite time, calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration (Clast) divided by the apparent terminal rate constant (λz): AUC(0-last) + Clast/λz.

Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration, calculated by linear up/log down trapezoidal summation.

Systemic clearance calculated as dose/ AUC(0-inf).

Volume of distribution at steady state following intravenous dosing, calculated as mean residence time (extrapolated to infinity) multiplied by systemic clearance.

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Volume of distribution was estimated by dividing the systemic clearance by apparent terminal rate constant (λz).

The terminal elimination rate constant (λz) is defined as the first-order rate constant describing the rate of decrease of drug concentration in the terminal phase. Apparent terminal rate constant was determined by linear regression of the terminal points of the log-linear concentration-time curve.