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

July 20, 2012 updated by: Novartis Pharmaceuticals

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 With Peanut Allergy

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • Diagnosis of acute peanut allergy as manifested by urticaria, angioedema, gastro-intestinal or respiratory tract symptoms, with acute onset of symptoms after ingestion (up to 2 hours).
  • Positive peanut food challenge at baseline, i.e., have objective allergic events at a level of 300mg (not cumulative) or below of peanut protein but not to the placebo test.

Main Exclusion Criteria:

  • Prior exposure to any monoclonal antibody treatment
  • Asthma patients on maintenance long acting beta-agonists
  • Use of systemic corticosteroids
  • Concomitant use of beta blockers, ACE inhibitors, tiotropium or ipratropium, antidepressants, oral beta-agonists
  • Use of immunosuppressants within 6 months of visit 1 Other protocol-defined inclusion/exclusion criteria may appy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QGE031 A
Drug: QGE031
QGE031 liquid for subcutaneous injection.
Experimental: QGE031 B
Drug: QGE031
QGE031 liquid for subcutaneous injection.
Experimental: QGE031 C
Drug: QGE031
QGE031 liquid for subcutaneous injection.
Experimental: QGE031 D
Drug: QGE031
QGE031 liquid for subcutaneous injection.
Placebo Comparator: Placebo A
Drug: Placebo
Placebo liquid for subcutaneous injection.
Placebo Comparator: Placebo B
Drug: Placebo
Placebo liquid for subcutaneous injection.
Placebo Comparator: Placebo C
Drug: Placebo
Placebo liquid for subcutaneous injection.
Placebo Comparator: Placebo D
Drug: Placebo
Placebo liquid for subcutaneous injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 10, 2011

First Submitted That Met QC Criteria

October 12, 2011

First Posted (Estimate)

October 13, 2011

Study Record Updates

Last Update Posted (Estimate)

July 23, 2012

Last Update Submitted That Met QC Criteria

July 20, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQGE031A2208
  • 2011-000631-92 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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