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

NCT ID: NCT01451450

Last Updated: 2012-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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Peanut Allergy

Keywords

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Peanut Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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QGE031 A

Group Type EXPERIMENTAL

QGE031

Intervention Type DRUG

QGE031 liquid for subcutaneous injection.

QGE031 B

Group Type EXPERIMENTAL

QGE031

Intervention Type DRUG

QGE031 liquid for subcutaneous injection.

QGE031 C

Group Type EXPERIMENTAL

QGE031

Intervention Type DRUG

QGE031 liquid for subcutaneous injection.

QGE031 D

Group Type EXPERIMENTAL

QGE031

Intervention Type DRUG

QGE031 liquid for subcutaneous injection.

Placebo A

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo liquid for subcutaneous injection.

Placebo B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo liquid for subcutaneous injection.

Placebo C

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo liquid for subcutaneous injection.

Placebo D

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo liquid for subcutaneous injection.

Interventions

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QGE031

QGE031 liquid for subcutaneous injection.

Intervention Type DRUG

Placebo

Placebo liquid for subcutaneous injection.

Intervention Type DRUG

Eligibility Criteria

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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.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Countries

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Canada Germany Greece Italy Netherlands Switzerland United Kingdom United States

Other Identifiers

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2011-000631-92

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQGE031A2208

Identifier Type: -

Identifier Source: org_study_id