Clinical Trial: Efficacy and Safety of 4 Doses of QGE031 in Patients 18-50 Years of Age With Peanut Allergy

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Phase II, Randomized, Double Blind, Placebo-controlled, Parallel Design, Dose Ranging, Multi-center Trial of Four Levels of Exposure of QGE031 s.c. for 16 Weeks in Subjects Aged 18-50 Years of Age W

Brief Summary: This study will assess the clinical potency of several exposure levels of QGE031 in decreasing the sensitivity against peanut allergen.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome:

Original Primary Outcome: The increase in the threshold dose of peanut protein that includes objective hypersensitivity reactions after treatment assessed by double-blind, placebo-controlled food challenges (DBPCFC) before and after 16 weeks of treatment. [ Time Frame: From Baseline to end of treatment (16 weeks) ]

Current Secondary Outcome:

Original Secondary Outcome:

• The percentage of patients that experienced an increase from baseline to the end of treatment period in the threshold dose of at least 2 steps (or 10 fold) increase in peanut dose in the DBPCFC after 16 weeks of treatment. [ Time Frame: From Baseline to end of treatment (16 weeks) ]
  The threshold dose of peanut protein during the double blind placebo controlled food challenges (DBPCFC) will be classified as the step in which peanut protein concentration in a dose that are administered in escalation steps (3 - 10 - 30 - 100 - 300 - 1000 - 3000 mg) of peanut protein that elicited an objective hypersensitivity reaction.
• The mean number of steps improved from baseline threshold dose of peanut protein in the DBPCFC after 16 weeks of treatment. [ Time Frame: From Baseline to end of treatment (16 weeks) ]
  The threshold dose of peanut protein during the DBPCFC will be classified as the step in which peanut protein concentration in doses that are administered in escalation steps (3 - 10 - 30 - 100 - 300 - 1000 - 3000 mg) of peanut protein that elicited an objective hypersensitivity reaction. One step is half fold logarithmic (3.3 fold) increase, 2 steps is tenfold where each step is an increase in peanut protein concentration.
• The shift in the mean cumulative doses in peanut protein in the DBPCFC before exhibiting an objective allergic reaction after 16 weeks of treatment. [ Time Frame: From Baseline to end of treatment (16 weeks) ]
  The mean cumulative doses are classified by averaging the peanut protein concentrations consumed with each dose in total for that one DBPCFC. The shit is classified by the change in this mean cumulative dose from the first DBPCFC at baseline to the second DBPCFC at the end of treatment.
• From baseline, 8, 15, and 29 days (each a treatment day) and every four weeks thereafter, measure blood level of QGE031 (Pharmacokinetics) [ Time Frame: From baseline, 8, 15, and 29 days and every four weeks thereafter until the end of the study (30 weeks) ]
  Blood for analysis is drawn at the predetermined visits and before study drug administration on treatment visits.
• From baseline, 8, 15, and 29 days (each a treatment day) and every four weeks thereafter, measure blood level of total IgE (Pharmacodynamics) [ Time Frame: From baseline, 8, 15, and 29 days and every four weeks thereafter until the end of the study (30 weeks) ]
  Blood for analysis is drawn at the predetermined visits and before study drug administration on treatment visits.
• From baseline, 8, 15, and 29 days (each a treatment day) and every four weeks thereafter, measure blood level of free IgE (Pharmacodynamics) [ Time Frame: From baseline, 8, 15, and 29 days and four weeks thereafter until the end of the study (30 weeks) ]
  Blood for analysis is drawn at the predetermined visits and before study drug administration on treatment visits.

Dates:
Date Received: October 10, 2011
Date Started:
Date Completion:
Last Updated: July 20, 2012
Last Verified: July 2012