Peanut allergy MedDRA version: 20.1 Level: LLT Classification code 10034202 Term: Peanut allergy System Organ Class: 100000004870
Conditions
Interventions
Product Name: INP20
Product Code: INP20
Pharmaceutical Form: Oral powder
INN or Proposed INN: Aqueous extract of roasted defatted peanut
Sponsors
InnoUP Farma SL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 12 years and above at time of initial visit (either sex, any race, any ethnicity) Presence of specific IgE to peanuts (positive skin prick test, diameter of wheal > 3.0 mm) and a positive test for the presence of peanut IgEs ([CAP-FEIA] > 0.33 kUA/L). A history of significant clinical symptoms (urticaria, angioedema, rhinorrhea, nasal congestion, pruritis, sneezing, abdominal pain, emesis, diarrhea, wheezing, shortness of breath, lip/tongue swelling, throat itching, throat swelling or impending sense of doom) occurring within 60 minutes of ingesting peanuts. A positive food challenge test (DBPCFC) against peanut at a cumulative dose of less than 10 grams of peanut protein. Provision of signed informed consent for participation in the study. In participants aged 12–17 years the informed consent will be signed and data by the participant in addition to the parent(s) or the participant's legally acceptable representative(s). Availability of self-injectable epinephrine at home and adequate training for its proper use. Potentially fertile female participants must either agree to be sexually inactive or to the use of appropriate contraceptive measures for the duration of the study and for a period of 1 month afterwards. Provision of additional signed informed consent if biological samples extracted during the course of the study (i.e. blood samples) are to be stored for a period of time longer than the current research period or if they are to be used for a purpose other than that mentioned in the global research proposal. Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: History of severe anaphylaxis to peanut as defined by respiratory distress with cyanosis, hypoxemia (O2 sat 400 microg/day or budesonide > 800 microg/day) or montelukast. Two or more systemic corticosteroid courses for asthma in the past year or one oral corticosteroid course for asthma within three months prior to enrollment or between enrollment and study initiation. Prior intubation/mechanical ventilation for asthma. Chronic gastrointestinal diseases including celiac disease, inflammatory bowel disease, eosinophilic gastrointestinal disorders, irritable bowel syndrome, gastric or intestinal cancer, diverticulitis and acitve peptic ulcer or recurrent gastrointestinal symptoms of undiagnosed etiology in the past year. Primary or secondary immunodeficiency, including IgA deficiency; HIV positive, or immunopathology of any kind. History of other chronic diseases (except asthma, rhinitis, atopic dermatitis) with severity requiring treatment (type I diabetes or uncontrolled type 2 diabetes, uncontrolled hypertension, heart disease, etc.); malignancies or serious psychological disorders. A severe reaction at initial double-blind placebo-controlled food challenge, defined as either: life-threatening anaphylaxis (with severe hypotension and/or severe bronchospasm), or a reaction requiring hospitalization. Inability to discontinue antihistamines for seven days before skin testing and oral food challenges. Diagnosis with other serious food allergies defined as those which have required intubation and/or ICU admission. Chronic use of beta blockers, angiotensin converting enzyme inhibitors, or monoamine oxidase inhibitors, proton pump inhibitors, H2-bloquers, prokinetic drugs and laxatives. Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding. Past or current medical problems or findings from physical examination or laboratory testing that a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This phase I/II trial has two primary objectives; in phase I (part A), the primary objective is to determine the safety and tolerability of rising oral doses of INP20 administered to patients with peanut allergy. The maximum tolerated dose and the safe dose range of INP20 will be determined. In the extension to the trial (phase II or Part B), the primary objective is to determine safety and tolerability of INP20 in repeated dose oral administration at the doses determined in phase I of the trial throughout a 6-month treatment period. ; Secondary Objective: In phase I (part A) of the trial, the secondary objective is to determine the effect of rising oral doses of INP20 on a pharmacodynamic parameter, namely serum IgG4 concentrations in patients with peanut allergy. In phase II (part B) of the trial, there are two secondary objectives; firstly, to assess the potential efficacy of the dose regimens determined in phase I of the trial versus placebo in an expanded treatment cohort after a 6 month treatment period. Secondly, to assess changes from baseline in immune parameters associated with INP20 repeat dose oral administration after 1, 3 and 6 months treatment. ; Primary end point(s): Phase I of the study (Part A): Incidence of treatment-related adverse events with each dose level of INP20. Number of participants with dose limiting toxicities. Phase II of the study (Part B): Incidence of adverse events (AEs) and serious adverse events (SAEs), and AEs/SAEs leading to discontinuation. ; Timepoint(s) of evaluation of this end point: Phase I of the study (Part A): continous evaluation of the primary endpoints. Phase II of the study (Part B): continous evaluation of the primary endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase I of the study (Part A): Incidence of adverse events (AEs) and serious adverse events (SAEs), and AEs/SAEs leading to discontinuation. Incidence of systemic allergic symptoms and relatedness to treatment. Other safety parameters (vital signs, results of physical examinations, clinical chemistry, haematological parameters, immunological tests). Changes in IgG subtype (IgG4). Basophil activation as assessed by basophil activation test (BAT). Phase II of the study (Part B): Safety parameters (results of physical examinations, haematological parameters, clinical chemistry). Systemic allergic symptoms and relatedness to treatment. Differences in reaction thresholds to peanut in treatment group versus placebo group in food challenge test. Changes in allergen specific biomarkers (or immune parameters) associated with treatment. Parameters analysed will include: peanut-specific IgE, IgG and IgG4 response versus complete extract and some allergenic components of peanut; specific basophil activation against nanoparticles (NP), NP-peanut and raw peanut extract; mast cell responses through skin prick testing and endpoint titration; specific T-cell cytokine responses (intracellular IL-10, IL-4, IL-5, IL-13 and TGF-beta); regulatory T-cell activation (Treg1, CD4+ and CD25+ subpopulations). ; Timepoint(s) of evaluation of this end point: Phase I of the study (Part A): AEs and SAEs - continuous evaluation. Allergic symptoms - continuous evaluation. Vital signs, IgG subtype test and basophil activation test - baseline visit (day 0) and 14. Physical examinations, clinical chemistry and haematological parameters - screening visit (days -15 to -1) and day 14. Phase II of the stu | — |
Countries
Spain
Contacts
Public ContactMaite Agüeros
InnoUp Farma SL
Outcome results
None listed