HAL-MPE1 First-in-human

NCT02163018 | Completed Phase 1 DMC

• 2 other identifiers: HAL-MPE1/00432013-004238-13
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peanut Allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

HAL-MPE1

EXPERIMENTAL

Subcutaneous administration of increasing doses of HAL-MPE1.

Drug: HAL-MPE1

Placebo

PLACEBO COMPARATOR

Subcutaneous administration of placebo

Drug: Placebo

Interventions

HAL-MPE1 DRUG

Subcutaneous administration of increasing doses of HAL-MPE1

Also known as: HAL-MPE1: modified peanut extract

HAL-MPE1

Placebo DRUG

Subcutaneous administration of increasing doses of placebo

Also known as: HAL-MPE1 placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• HAL Allergy: lead

Study Sites (1)

Carsten Bindslev-Jensen

Odense, DK 5000, Denmark

Location

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Carsten Bindslev-Jensen, Prof. Dr.

  Hudafdeling I og Allergicentret, Odense Universitetshospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: June 13, 2014
• Study Start: June 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 10, 2015

Record last verified: 2015-07

Locations

DK (1)