Placebo-Controlled Study to Investigate ANB020 Activity in Adult Patients With Peanut Allergy

• ClinicalTrials.gov Identifier: NCT02920021
• Recruitment Status: Completed
• First Posted: September 30, 2016
• Last Update Posted: June 26, 2018
• Sponsor: AnaptysBio, Inc.
• Information provided by (Responsible Party): AnaptysBio, Inc.

Tracking Information

• First Submitted Date: September 26, 2016
• First Posted Date: September 30, 2016
• Last Update Posted Date: June 26, 2018
• Study Start Date: December 2016
• Actual Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 28, 2016)

• Safety of ANB020 in adult patients with peanut allergy [ Time Frame: through study completion, an average of 60 days ]
  Occurrence of adverse events
• Change in Laboratory Values [ Time Frame: through study completion, an average of 60 days ]
  Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 28, 2016)

• Clinical Scores of oral food challenge symptoms [ Time Frame: At pre-treatment and Day 14 ]
  Change in clinical scores of the oral food challenge symptoms before and after treatment
• Change in serum levels of specific cytokines [ Time Frame: through study completion, an average of 60 days ]
  Change in serum levels of specific cytokines before and after treatment with ANB020
• Describe Limited Pharmacokinetics [ Time Frame: through study completion, an average of 60 days ]
  Peak Plasma Concentration (Cmax)
• Describe Limited Pharmacokinetics [ Time Frame: through study completion, an average of 60 days ]
  Time to maximum plasma concentration (Tmax)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Placebo-Controlled Study to Investigate ANB020 Activity in Adult Patients With Peanut Allergy
• Official Title: Placebo-Controlled Study to Investigate ANB020 Activity in Adult Patients With Peanut Allergy
• Brief Summary: The purpose of this study is to determine ANB020 safety, tolerability and activity in adult patients with peanut allergy.
• Detailed Description: This is a multi-center, randomized, double-blind, placebo-controlled, proof of concept study to assess the safety and tolerability of ANB020 in adult patients with peanut allergy.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Peanut Allergy

Intervention

• Drug: ANB020
  ANB020
• Drug: Placebo
  Placebo

Study Arms

• Experimental: ANB020
  ANB020, administration of ANB020
  Intervention: Drug: ANB020
• Placebo Comparator: Placebo
  Placebo, administration of Placebo
  Intervention: Drug: Placebo

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 28, 2016): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2018
• Actual Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Male and female patients with age >18 years and able to give informed consent.
• Patients 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 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 kg/m2 (inclusive) and total body weight >50 kg (110 lb). BMI = weight (kg)/(height [m2]).
• 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 patients defined as (1) aged over 45 years with at least 1 year of amenorrhea and levels of follicle stimulating hormone over 20 IU/L or (2) aged over 50 years with at least 1 year of amenorrhea.
• Male patients 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.

Exclusion Criteria:

• Have concomitant dermatological or medical condition(s) which may interfere with the Investigator's ability to evaluate the patient'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 subject 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 ANB020 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).
• Other significant medical conditions that in the opinion of the Principal Investigator, prevent participation in the study.
• History of drug, alcohol or other substance abuse, or other factors limiting the ability to cooperate and to comply with the study protocol.
• Have any other physical, mental, or medical conditions which, in the opinion of the Investigator, make study participation inadvisable or could confound study assessments.
• Receipt of a live attenuated vaccine within 4 weeks before screening.
• Planned surgery during the study or 30 days before screening.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02920021
• Other Study ID Numbers: ANB020-003
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: AnaptysBio, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: AnaptysBio, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Marco Londei, MD; AnaptysBio, Inc.

• PRS Account: AnaptysBio, Inc.
• Verification Date: June 2018