HAL-MPE1 First-in-human

Study Overview
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Brief Summary
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Currently, there is no effective causal treatment for peanut allergy. A chemically modified, aluminium hydroxide adsorbed peanut extract (HAL-MPE1) for subcutaneous administration has been developed. Results from in vitro and in vivo preclinical studies demonstrate the immunotherapeutic potential of HAL-MPE1. Therefore, a phase I, single-centre clinical trial has been designed to assess the safety and tolerability of HAL-MPE1 in peanut allergic patients.

Official Title
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A First-in-human, Randomized, Double Blind, Placebo Controlled, Single-centre Study to Assess the Safety and Tolerability of HAL-MPE1 in Patients With Peanut Allergy

Conditions
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Peanut Allergy

Intervention / Treatment
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* Drug: HAL-MPE1
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent. Male or female subjects aged 18-65 years. A well-documented medical history of systemic reactions after ingestion of peanut Positive food challenge at ≤1.5 gram peanut protein ingestion within the last 2 years Positive serum specific anti-peanut and Ara h 2 Immunoglobulin E (IgE-test) (>0.7 kiloUnits(kU)/L) within the last 2 years Forced expiratory volume at one second (FEV1)>70% of predicted value Exclusion Criteria: Subjects with a history of severe anaphylaxis to peanut with the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence) during challenge with peanuts. Baseline serum tryptase level >20 µg/l Known allergy or known hypersensitivity to (placebo) excipients Participation in any interventional study aimed at desensitizing the peanut allergy in the past Any specific immunotherapy (SCIT, SLIT or OIT) during the study period Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs Significant active malignancies or any malignant disease within the past 5 years Severe uncontrolled diseases that could increase the risk for patients participating in the study, including but not limited to: any severe or unstable lung diseases; endocrine diseases; clinically significant renal or hepatic diseases, or haematological disorders; or severe ongoing symptomatic allergic diseases History of cardiovascular disease, uncontrolled hypertension or arrhythmias Diseases with a contraindication for the use of adrenaline (e.g. hyperthyroidism, glaucoma) Use of systemic steroids within 4 weeks before start of the study and during the study Treatment with β-blockers/ACE inhibitors Vaccination within one week before start of therapy or during study Anti-IgE/anti-Tumor necrosis factor (TNF) therapy or any biologic immunomodulatory therapy within the 6 months prior to inclusion and during the study Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study Pregnancy (test performed at screening), lactation or inadequate contraceptive measures for women of child-bearing age (contraceptive measures considered adequate are: intrauterine devices, hormonal contraceptives, such as contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release) Alcohol, drug or medication abuse within the past year Any clinically significant abnormal laboratory parameter at screening Lack or expected lack of cooperation or compliance Severe psychiatric, psychological, or neurological disorders Patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigators

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HAL-MPE1<br>Subcutaneous administration of increasing doses of HAL-MPE1. | Drug: HAL-MPE1<br>* Subcutaneous administration of increasing doses of HAL-MPE1<br>* Other names: HAL-MPE1: modified peanut extract;|
| Placebo Comparator: Placebo<br>Subcutaneous administration of placebo | Drug: Placebo<br>* Subcutaneous administration of increasing doses of placebo<br>* Other names: HAL-MPE1 placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of a SCIT-treatment with HAL-MPE1 in patients with peanut allergy. | Occurrence of early and late local reactions Occurrence of early and late systemic reactions Occurrence of adverse events (clinically relevant abnormalities of the physical examination will be documented as adverse events) Changes in laboratory values, vital signs, ECG and lung function. | up to 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum levels of allergen specific immunoglobulins |  | before and after 15-20 weeks of treatment | 
| Change in basophil histamine release test |  | before and after 15-20 weeks treatment | 
| Change in titrated skin prick test |  | before and after 15-20 weeks of treatment |