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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Summary: 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.
Sponsor: AnaptysBio, Inc.

Current Primary Outcome:

• 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: Same as current

Current Secondary Outcome:

• 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: Same as current

Information By: AnaptysBio, Inc.

Dates:
Date Received: September 26, 2016
Date Started: December 2016
Date Completion: September 2017
Last Updated: January 23, 2017
Last Verified: January 2017