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HAL-MPE1 First-in-human (HAL-MPE1/0043)

Primary Purpose

Peanut Allergy

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
HAL-MPE1
Placebo
Sponsored by
HAL Allergy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Allergy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed informed consent.
  2. Male or female subjects aged 18-65 years.
  3. A well-documented medical history of systemic reactions after ingestion of peanut
  4. Positive food challenge at ≤1.5 gram peanut protein ingestion within the last 2 years
  5. Positive serum specific anti-peanut and Ara h 2 Immunoglobulin E (IgE-test) (>0.7 kiloUnits(kU)/L) within the last 2 years
  6. Forced expiratory volume at one second (FEV1)>70% of predicted value

Exclusion Criteria:

  1. 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.
  2. Baseline serum tryptase level >20 µg/l
  3. Known allergy or known hypersensitivity to (placebo) excipients
  4. Participation in any interventional study aimed at desensitizing the peanut allergy in the past
  5. Any specific immunotherapy (SCIT, SLIT or OIT) during the study period
  6. Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
  7. Significant active malignancies or any malignant disease within the past 5 years
  8. 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
  9. History of cardiovascular disease, uncontrolled hypertension or arrhythmias
  10. Diseases with a contraindication for the use of adrenaline (e.g. hyperthyroidism, glaucoma)
  11. Use of systemic steroids within 4 weeks before start of the study and during the study
  12. Treatment with β-blockers/ACE inhibitors
  13. Vaccination within one week before start of therapy or during study
  14. Anti-IgE/anti-Tumor necrosis factor (TNF) therapy or any biologic immunomodulatory therapy within the 6 months prior to inclusion and during the study
  15. 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
  16. 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)
  17. Alcohol, drug or medication abuse within the past year
  18. Any clinically significant abnormal laboratory parameter at screening
  19. Lack or expected lack of cooperation or compliance
  20. Severe psychiatric, psychological, or neurological disorders
  21. Patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigators

Sites / Locations

  • Carsten Bindslev-Jensen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HAL-MPE1

Placebo

Arm Description

Subcutaneous administration of increasing doses of HAL-MPE1.

Subcutaneous administration of placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in serum levels of allergen specific immunoglobulins
Change in basophil histamine release test
Change in titrated skin prick test

Full Information

First Posted
June 5, 2014
Last Updated
July 9, 2015
Sponsor
HAL Allergy
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1. Study Identification

Unique Protocol Identification Number
NCT02163018
Brief Title
HAL-MPE1 First-in-human
Acronym
HAL-MPE1/0043
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HAL Allergy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HAL-MPE1
Arm Type
Experimental
Arm Description
Subcutaneous administration of increasing doses of HAL-MPE1.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subcutaneous administration of placebo
Intervention Type
Drug
Intervention Name(s)
HAL-MPE1
Other Intervention Name(s)
HAL-MPE1: modified peanut extract
Intervention Description
Subcutaneous administration of increasing doses of HAL-MPE1
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
HAL-MPE1 placebo
Intervention Description
Subcutaneous administration of increasing doses of placebo
Primary Outcome Measure Information:
Title
Safety of a SCIT-treatment with HAL-MPE1 in patients with peanut allergy.
Description
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.
Time Frame
up to 20 weeks
Secondary Outcome Measure Information:
Title
Change in serum levels of allergen specific immunoglobulins
Time Frame
before and after 15-20 weeks of treatment
Title
Change in basophil histamine release test
Time Frame
before and after 15-20 weeks treatment
Title
Change in titrated skin prick test
Time Frame
before and after 15-20 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carsten Bindslev-Jensen, Prof. Dr.
Organizational Affiliation
Hudafdeling I og Allergicentret, Odense Universitetshospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carsten Bindslev-Jensen
City
Odense
ZIP/Postal Code
DK 5000
Country
Denmark

12. IPD Sharing Statement

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HAL-MPE1 First-in-human

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