peanut allergy
Conditions
Interventions
Treatment with 1 of the 4 dosages of QGE031 or placebo.
Sponsors
Novartis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male and female subject 18-50y of age , who have a diagnosis of acute peanut allergy as manifested by urticaria, angioedema, respiratory tract symptoms, or hypotensive symptoms, with acute onset of symptoms after ingestion (up to 2h) • Positive food challenge test at baseline • Weight at least 40 kg.
Exclusion criteria
Exclusion criteria: • Prior exposure to any monoclonal antibody treatment, e.g. prior QGE031 or Xolair use within 6 months prior to study entry • Poorly controlled asthma • Concomitant use of systemic immunosuppressant, beta blockers, ACE inhibitors or tricyclic antidepressants • History of any of severe anaphylaxis as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or SpO2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QGE031 dose response relationship for the increase in the threshold dose of peanut protein that induces objective hypersensitivity reactions after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of patients that experienced an increase from baseline to the end of treatment period in the threshold dose of at least 2 steps (or 10 fold) increase in peanut dose; safety and tolerability. | — |
Countries
Netherlands
Outcome results
None listed