Peanut allergy MedDRA version: 14.0 Level: LLT Classification code 10034202 Term: Peanut allergy System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Product Code: QGE031
Pharmaceutical Form: Solution for injection
Current Sponsor code: QGE031
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 140-
Pha
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent obtained before any assessment is performed • Must 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 2 hours). • Have a positive peanut food challenge at baseline , i.e. have objective allergic events at a level of 300mg or below of peanut protein but not to the placebo. • Eligibility to the food challenge requires fulfillment of all other eligibility criteria at visit 1. • Must weigh = 40kg Additional inclusion criteria are listed in the clinical study protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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. Asthma control will be assessed by the Asthma Control Questionnaire (ACQ). Patients with a score =0.75 won’t be eligible for this study. Also, patients should have a FEV1 >70% of their predicted value. • Concomitant use of systemic immunosuppressant, beta blockers, ACE inhibitors or tricyclic antidepressants • History of severe anaphylaxis to peanut or omalizumab as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or SpO2 < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence) • Women of child-bearing potential unless they use highly effective contraception Additional exclusion criteria are listed in the clinical study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The increase in the threshold dose of peanut protein that induces objective hypersensitivity reactions after treatment assessed by double-blind, placebo-controlled oral food challenges (DBPCFC) before and after 16 weeks of treatment.;Secondary Objective: 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 in the DBPCFC after 16 weeks of treatment. Other secondary objectives are listed in the clinical study protocol.;Primary end point(s): The increase in the threshold dose of peanut protein that induces objective hypersensitivity reactions after treatment assessed by double-blind, placebo-controlled oral food challenges (DBPCFC) before and after 16 weeks of treatment.;Timepoint(s) of evaluation of this end point: Timeframe: 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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 in the DBPCFC after 16 weeks of treatment.;Timepoint(s) of evaluation of this end point: Timeframe: 16 weeks | — |
Countries
Canada, Greece, Netherlands, Switzerland, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed