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

Novartis

Status and phase: Withdrawn; Phase 2

Conditions: Peanut Allergy

Treatments: Drug: Placebo; Drug: QGE031

Study type: Interventional

Funder types: Industry

Identifiers

NCT01451450

CQGE031A2208

2011-000631-92 (EudraCT Number)

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 8 patient groups, including a placebo group

QGE031 A

Experimental group

Treatment:

Drug: QGE031

QGE031 B

Experimental group

Treatment:

Drug: QGE031

QGE031 C

Experimental group

Treatment:

Drug: QGE031

QGE031 D

Experimental group

Treatment:

Drug: QGE031

Placebo A

Placebo Comparator group

Treatment:

Drug: Placebo

Placebo B

Placebo Comparator group

Treatment:

Drug: Placebo

Placebo C

Placebo Comparator group

Treatment:

Drug: Placebo

Placebo D

Placebo Comparator group

Treatment:

Drug: Placebo