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

Primary Purpose

Peanut Allergy

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

QGE031

Placebo

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring Peanut Allergy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Arm Label

QGE031 A

QGE031 B

QGE031 C

QGE031 D

Placebo A

Placebo B

Placebo C

Placebo D

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01451450

First Posted

October 10, 2011

Last Updated

July 20, 2012

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01451450

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Withdrawn

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peanut Allergy

Keywords

Peanut Allergy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QGE031 A

Arm Type

Experimental

Arm Title

QGE031 B

Arm Type

Experimental

Arm Title

QGE031 C

Arm Type

Experimental

Arm Title

QGE031 D

Arm Type

Experimental

Arm Title

Placebo A

Arm Type

Placebo Comparator

Arm Title

Placebo B

Arm Type

Placebo Comparator

Arm Title

Placebo C

Arm Type

Placebo Comparator

Arm Title

Placebo D

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

QGE031

Intervention Description

QGE031 liquid for subcutaneous injection.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo liquid for subcutaneous injection.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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