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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01451450
First received: October 10, 2011
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Peanut Allergy
Drug: QGE031
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 With Peanut Allergy

Resource links provided by NLM:


Further study details as provided by Novartis:

Enrollment: 0
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451450

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01451450     History of Changes
Other Study ID Numbers: CQGE031A2208, 2011-000631-92
Study First Received: October 10, 2011
Last Updated: July 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Peanut Allergy

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

ClinicalTrials.gov processed this record on April 16, 2014