- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02991885
HAL-MPE1 Safety and Tolerability Study
February 17, 2020 updated by: HAL Allergy
A Randomized, Double-blind, Placebo-controlled, Multi-centre Study to Assess the Safety, Tolerability and Immunologic Effects of HAL-MPE1 Subcutaneous Immunotherapy in Adult and Paediatric Subjects With Peanut Allergy
The aim of this study is to confirm safety and tolerability of incremental doses of HAL-MPE1 subcutaneous immunotherapy (SCIT) in peanut allergic adults, and subsequently assess the safety and tolerability in adolescents and children with peanut allergy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
At the time of the study there was no effective treatment available for peanut allergy other than avoidance of peanut allergens.
There was high unmet medical need for a disease modifying treatment for peanut allergy, especially for peanut allergic children, since this age group is at highest risk of peanut-related anaphylaxis requiring hospitalization.
A chemically modified, aluminum hydroxide adsorbed peanut extract (HAL-MPE1) for subcutaneous administration has been developed.
The safety and tolerability of HAL-MPE1 have been established in a First-in-human (FIH) study in adults.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Mississauga, Ontario, Canada, L4W 1A4
- Inflamax Research Limited
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Maryland
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Baltimore, Maryland, United States, 21287
- John Hopkins Hospital University-Divison of Pediatric Allergy
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New York
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New York, New York, United States, 10029
- Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai
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North Carolina
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Chapel Hill, North Carolina, United States, 27517
- UNC Rheumatolory Allergy & Immunology Clinic
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Oklahoma
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Tulsa, Oklahoma, United States, 74136
- Allergy, Asthma and Immunology Center
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Texas
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San Antonio, Texas, United States, 78251
- South Texas Allergy & Asthma Medical Professionals (STAAMP)
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Washington
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Seattle, Washington, United States, 98105
- ASTHMA, Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed informed consent/assent
- Male or female subjects aged 5- 50 years
- A well-documented medical history of systemic reactions after ingestion of peanut
- Positive serum specific anti-peanut (>5.0 kU/L) and Ara h 2 Immunoglobulin E (IgE)-test (>2.0 kU/L)
- Skin prick test (SPT) to peanut ≥3 mm compared to negative control within the last 2 years
- Forced expiratory volume at first second (FEV1)>80% predicted (adults and adolescents) or Peak expiratory flow(PEF)>80% predicted (children)
- Negative pregnancy test at screening for females of childbearing potential
Females of childbearing age must be using an effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of participation in the study. Contraceptive measures considered adequate are:
- hormonal contraceptives such as contraceptive pills, transdermal patches, intrauterine device (IUD), intrauterine system (IUS) implant, or vaginal ring (started - least 4 weeks prior to Investigational Medicinal Product (IMP) administration)
- double barrier methods: e.g. condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent
- surgical sterilization of the female participant (removal of the uterus or ovaries or tubal ligation)
- participants who are postmenopausal (12 consecutive months without a period) for at least 2 years
- male partner sterilization (vasectomy with documentation of azoospermia) prior to the female patient's entry into trial and is the sole sexual partner for that female patient
- sexual abstinence or having no sexual relationship with a man.
Exclusion Criteria:
- Subjects with a history of severe anaphylaxis to peanut with the following symptoms: hypotension, neurological compromise (collapse, loss of consciousness or incontinence) after ingestion of peanuts
- Baseline serum tryptase level >20 µg/l
- Known allergy or hypersensitivity to an excipient in the study drug or placebo
- Clinical features of moderate or severe persistent asthma (as guided by the 2007 NHLBI Guidelines and according to the opinion of the investigator)
- Asthma with FEV1<80% predicted (adults, adolescents) or PEF <80% predicted (children)
- Asthma Control Test (ACT) ≤ 19
- Asthma attack/exacerbation within the last 3 months
- Hospitalization due to asthma within the last year
- Two or more courses of oral steroids within the last 6 months
- History of intubation /mechanical ventilation due to allergies or asthma
- Participation in any interventional study with peanut immunotherapy in the last year
- Any specific immunotherapy (SCIT, Sublingual Immunotherapy (SLIT) or OIT) during the study period
- Severe immune disorders (including autoimmune diseases) and/or diseases requiring immunosuppressive drugs
- Presence of chronic urticaria, atopic dermatitis with flare or atopic dermatitis with SCORAD>40
- Active malignancies or any malignant disease within the past 5 years
- Severe (uncontrolled) diseases that could increase the risk for subjects participating in the study, including but not limited to: any severe or unstable lung diseases; endocrine diseases; clinically significant renal or hepatic diseases, renal impairment, haematological disorders; severe ongoing symptomatic allergic diseases
- History of cardiovascular disease, uncontrolled hypertension or arrhythmias
- Diseases with a contraindication for the use of epinephrine (e.g. hyperthyroidism, glaucoma)
- Use of systemic steroids within 4 weeks before start of the study and during the study
- Treatment with beta-blockers or angiotensin-converting enzyme (ACE) inhibitors
- Vaccination within one week before start of therapy or during study unless considered necessary based on the opinion of the investigator.
- Anti-IgE/anti-Tumor Necrosis Factor (TNF)/omalizumab 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
- For female adolescents and adults of childbearing potential: 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, sexual abstinence or having no sexual relationship with a man)
- 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
- Unable to use the epinephrine pen correctly
- Severe psychiatric, psychological, or neurological disorders
- Subjects who are employees of the sponsor, institution or 1st degree relatives or partners of the investigators
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: HAL-MPE1
HAL-MPE1 is an off-white to white liquid suspension containing modified peanut extract
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Weekly subcutaneous administrations of HAL-MPE1
Other Names:
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Placebo Comparator: HAL-MPE1 placebo
HAL-MPE1 placebo without modified peanut extract
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Weekly subcutaneous administrations of HAL-MPE1 placebo
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of local and systemic reactions
Time Frame: within 30 minutes to >4 hours
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Occurrence of immediate (≤ hour), early (1-4) and late (> 4 hours) local and systemic reactions reactions
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within 30 minutes to >4 hours
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Occurrence of treatment emergent adverse events
Time Frame: Throughout study completion, an average 16 weeks
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Treatment emergent adverse events will be collected by reporting of adverse events and by clinical relevant changes in laboratory values, vital signs, lung function and aluminum levels in plasma and urine
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Throughout study completion, an average 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes immunoglobulin levels
Time Frame: Before and after 4, 8 and 16 weeks of treatment
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Serum specific and component specific immunoglobulin levels
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Before and after 4, 8 and 16 weeks of treatment
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Changes in basophil activation
Time Frame: Before and after 16 weeks treatment
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In vitro determination of basophil activation upon antigen stimulation
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Before and after 16 weeks treatment
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Changes in histamine release test
Time Frame: Before and after 16 weeks treatment
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Determination of histamine release and total cellular histamine content induced by peanut
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Before and after 16 weeks treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Wood, MD, John Hopkins Hospital Unversity-Divison of Pediatric Allergy
- Principal Investigator: Scott Sicherer, MD, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai
- Principal Investigator: Edwin Kim, MD, UNC Rheumatolory Allergy & Immunology Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
April 1, 2019
Study Completion (Actual)
September 1, 2019
Study Registration Dates
First Submitted
November 21, 2016
First Submitted That Met QC Criteria
December 9, 2016
First Posted (Estimate)
December 14, 2016
Study Record Updates
Last Update Posted (Actual)
February 19, 2020
Last Update Submitted That Met QC Criteria
February 17, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HAL-MPE1/0049
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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