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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This study has been withdrawn prior to enrollment.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

October 10, 2011
July 20, 2012
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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) ] [ Designated as safety issue: No ]
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 doses that are administered in escalation steps (3 - 10 - 30 - 100 - 300 - 1000 - 3000 mg) of peanut protein that elicited an objective hypersensitivity reaction. An objective hypersensitivity reaction can be classified as an onset of severe skin, respiratory, cardiovascular/neurologic, and gastrointestinal symptoms.
Complete list of historical versions of study NCT01451450 on ClinicalTrials.gov Archive Site
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  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Blood for analysis is drawn at the predetermined visits and before study drug administration on treatment visits.
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Efficacy and Safety of 4 Doses of QGE031 in Patients 18-50 Years of Age With Peanut Allergy
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.

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Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Peanut Allergy
  • Drug: QGE031
    QGE031 liquid for subcutaneous injection.
  • Drug: Placebo
    Placebo liquid for subcutaneous injection.
  • Experimental: QGE031 A
    Intervention: Drug: QGE031
  • Experimental: QGE031 B
    Intervention: Drug: QGE031
  • Experimental: QGE031 C
    Intervention: Drug: QGE031
  • Experimental: QGE031 D
    Intervention: Drug: QGE031
  • Placebo Comparator: Placebo A
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo B
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo C
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo D
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT01451450
CQGE031A2208, 2011-000631-92
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Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP