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

NCT02920021 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ANB020-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine etokimab safety, tolerability and activity in adult participants with peanut allergy.

Conditions

Peanut Allergy

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  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.

  From first dose of study drug up to 45 days.

• Change From Baseline in Cumulative Tolerated Peanut Dose During Oral Food Challenge

  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.

  Baseline and Day 14

Secondary Outcomes (10)

• Change From Baseline in Oral Food Challenge Symptom Score at Day 14

  Baseline and Day 14

• Maximum Observed Concentration (Cmax) of Etokimab

  Day 1 predose, 0.5 hours after the start of the infusion, end of infusion (EOI), 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.

• Time to Maximum Observed Concentration (Tmax) of Etokimab

  Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.

• Area Under the Concentration-time Curve in Serum From Time Zero Extrapolated to Infinite Time (AUC0-inf) for Etokimab

  Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.

• Area Under the Concentration-time Curve in Serum From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) for Etokimb

  Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.

Study Arms (2)

Etokimab

EXPERIMENTAL

Participants received a single dose of 300 milligrams (mg) etokimab administered by 1-hour intravenous (IV) infusion on Day 1.

Drug: Etokimab

Placebo

PLACEBO COMPARATOR

Participants received a single dose of placebo administered by 1-hour IV infusion on Day 1.

Drug: Placebo

Interventions

Etokimab DRUG

Humanized monoclonal antibody, administered by intravenous infusion

Also known as: ANB020

Etokimab

Placebo DRUG

Administered by intravenous infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants with age \> 18 years and able to give informed consent.
• Participants with a confirmed clinically allergic response to peanut.
• Positive clinical reaction during the peanut oral food challenge and no clinical reaction during the placebo challenge
• Positive peanut allergy skin prick test \> 3 millimeters (mm) of the negative control and detectable serum peanut-specific Immunoglobulin E (IgE) levels by ImmunoCAP testing.
• Body mass index (BMI) of 18 to 36 kilogram per square meter (kg/m\^2) inclusive) and total body weight \> 50 kg (110 lb). BMI = weight (kg)/(height \[m\^2\]).
• Willing and able to comply with the study protocol requirements.
• Have the ability to read and understand the study procedures and have the ability to communicate meaningfully with the Investigator and staff.
• Women of childbearing potential, must have a negative serum pregnancy test at screening and Day 1, and be surgically sterile or using an acceptable method of contraception throughout the study and for 15 weeks after the last administration of investigational product. Postmenopausal participants defined as (1) aged over 45 years with at least 1 year of amenorrhea and levels of follicle stimulating hormone over 20 international units per liter (IU/L) or (2) aged over 50 years with at least 1 year of amenorrhea.
• Male participants must be willing to use effective methods of contraception during the entire study period and for 15 weeks after the last administration of investigational product.

You may not qualify if:

• Have concomitant dermatological or medical condition(s) which may interfere with the Investigator's ability to evaluate the participant's response to the investigational product.
• Have experienced severe life-threatening anaphylactic reactions to peanuts within 6 months before screening (i.e., requiring an intensive care unit \[ICU\] admission).
• Positive clinical reaction observed during the placebo oral food challenge.
• Participation in any interventional study for the treatment of peanut and/or food allergies in the 12 months before screening.
• Have received any investigational product or been part of any interventional clinical study within a period of 3 months or 5 half-lives (whichever is longer) before screening.
• Have received systemic corticosteroids, nonsteroidal, immunosuppressant, or immunomodulating drugs treatments within 2 weeks before screening.
• Use of beta blockers, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium channel blockers within 2 weeks before screening.
• History of ischemic cardiovascular diseases.
• Use of biologics within 6 months before screening or participant is in build-up phase of allergen immunotherapy (excluding peanut) and has not reached maintenance dose.
• Have received antibiotic treatment within 1 week before screening.
• Have a history of hypersensitivity or allergic reactions following infusions of human blood or blood components.
• Have a history of hypersensitivity or allergic reactions a component of etokimab formulation or the inactive ingredients (excipients).
• If female, are pregnant or lactating, or intend to become pregnant during the study period.
• Current diagnosis of asthma requiring Global Initiative for Asthma Assessment (GINA) Step 4 or higher treatment or asthma partially controlled or uncontrolled according to GINA classifications in the last three months before screening.
• History of a life threatening asthma attack within 1 year before screening (example: requiring an intensive care unit admission, intubation with mechanical ventilation).

Sponsors & Collaborators

• AnaptysBio, Inc.: lead

Study Sites (2)

Stanford Univ. Medical Center

Palo Alto, California, 94305, United States

Location

Asthma, Inc Clinical Research Center

Seattle, Washington, 98115, United States

Location

Related Publications (1)

• Chinthrajah S, Cao S, Liu C, Lyu SC, Sindher SB, Long A, Sampath V, Petroni D, Londei M, Nadeau KC. Phase 2a randomized, placebo-controlled study of anti-IL-33 in peanut allergy. JCI Insight. 2019 Nov 14;4(22):e131347. doi: 10.1172/jci.insight.131347.

  PMID: 31723064 RESULT

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Project Leader
• Organization: AnaptysBio, Inc.

info@anaptysbio.com

858-362-6295

Study Officials

• Bruce Randazzo, MD

  AnaptysBio, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 30, 2016
• Study Start: January 26, 2017
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: July 27, 2023
• Results First Posted: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)