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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by AnaptysBio, Inc.
Sponsor:
Information provided by (Responsible Party):
AnaptysBio, Inc.
ClinicalTrials.gov Identifier:
NCT02920021
First received: September 26, 2016
Last updated: January 23, 2017
Last verified: January 2017
  Purpose
The purpose of this study is to determine ANB020 safety, tolerability and activity in adult patients with peanut allergy.

Condition Intervention Phase
Peanut Allergy Drug: ANB020 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Placebo-Controlled Study to Investigate ANB020 Activity in Adult Patients With Peanut Allergy

Resource links provided by NLM:


Further study details as provided by AnaptysBio, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 20
Study Start Date: December 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ANB020
ANB020, administration of ANB020
Drug: ANB020
ANB020
Placebo Comparator: Placebo
Placebo, administration of Placebo
Drug: Placebo
Placebo

Detailed Description:
This is a single center, randomized, double-blind, placebo-controlled, proof of concept study to assess the safety and tolerability of ANB020 in adult patients with peanut allergy.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 32 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 (i.e., required hospitalization).
  • 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 8 weeks before screening.
  • Use of beta blockers, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium channel blockers within 4 weeks before screening.
  • History of ischemic cardiovascular diseases.
  • Use of biologics any other unconventional allergen immunotherapy within 12 months before screening.
  • 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 3 or higher treatment or asthma partially controlled or uncontrolled according to GINA classifications in the last three months before screening (Appendix I).
  • History of a life threatening asthma attack (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02920021

Contacts
Contact: Brian Kenney bkenney@anaptysbio.com

Locations
United States, California
Stanford Univ. Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Whitney Block, NP    650-724-6780    wmnp@stanford.edu   
Contact: Angelica He    650-724-6780    ahe@stanford.edu   
Sponsors and Collaborators
AnaptysBio, Inc.
Investigators
Study Director: Marco Londei, MD AnaptysBio, Inc.
  More Information

Responsible Party: AnaptysBio, Inc.
ClinicalTrials.gov Identifier: NCT02920021     History of Changes
Other Study ID Numbers: ANB020-003
Study First Received: September 26, 2016
Last Updated: January 23, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on June 22, 2017