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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This study has been withdrawn prior to enrollment.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
History of Changes
  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:

MedlinePlus related topics: Allergy
U.S. FDA Resources

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 June 17, 2013