Efficacy and safety study of 4 doses of QGE031 in patients 18-50 years of age with peanut allergy

Conditions: Peanut allergy
MedDRA version: 14.0Level: LLTClassification code 10034202Term: Peanut allergySystem Organ Class: 10021428 - Immune system disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2011-000631-92-GR

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

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

• 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.