E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034202 |
E.1.2 | Term | Peanut allergy |
E.1.2 | System Organ Class | 10021428 - Immune system disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Written informed consent obtained before any assessment is performed
• Must have a 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).
• 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 test.
• 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. |
|
E.4 | Principal 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 patients with Asthma Control Questionnaire (ACQ) score ≥0.75. Also, patients with a FEV1 <80% of their predicted value or FEV1/FVC <75% with or without controller medications.
• Concomitant use of immunosuppressants, beta blockers, ACE inhibitors, tiotropium, ipratropium, antidepressants or oral beta agonists.
• History of severe anaphylaxis as defined by WHO Grade 4.
• Women of child-bearing potential unless they use highly effective contraception
Additional and full details of exclusion criteria are listed in the clinical study protocol. |
|
E.5 End points |
E.5.1 | 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. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | 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. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Switzerland |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |