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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01451450

Enrollment

Registered

2011-10-13

Start date

Unknown

Completion date

Unknown

Last updated

2012-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peanut Allergy

Keywords

Peanut Allergy

Brief summary

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

Interventions

DRUGQGE031

QGE031 liquid for subcutaneous injection.

DRUGPlacebo

Placebo liquid for subcutaneous injection.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Inclusion 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/

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026