NCT01451450

Brief Summary

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

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2011

Completed
Last Updated

July 23, 2012

Status Verified

July 1, 2012

First QC Date

October 10, 2011

Last Update Submit

July 20, 2012

Conditions

Peanut Allergy

Keywords

Peanut Allergy

Study Arms (8)

QGE031 A

EXPERIMENTAL
Drug: QGE031

QGE031 B

EXPERIMENTAL
Drug: QGE031

QGE031 C

EXPERIMENTAL
Drug: QGE031

QGE031 D

EXPERIMENTAL
Drug: QGE031

Placebo A

PLACEBO COMPARATOR
Drug: Placebo

Placebo B

PLACEBO COMPARATOR
Drug: Placebo

Placebo C

PLACEBO COMPARATOR
Drug: Placebo

Placebo D

PLACEBO COMPARATOR
Drug: Placebo

Interventions

QGE031DRUG

QGE031 liquid for subcutaneous injection.

QGE031 AQGE031 BQGE031 CQGE031 D
PlaceboDRUG

Placebo liquid for subcutaneous injection.

Placebo APlacebo BPlacebo CPlacebo D

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peanut Hypersensitivity

Interventions

ligelizumab

Condition Hierarchy (Ancestors)

Nut and Peanut HypersensitivityFood HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2011

First Posted

October 13, 2011

Last Updated

July 23, 2012

Record last verified: 2012-07