Peanut AllergyPhase 1HAL-MPE1/0043NCT02163018
HAL-MPE1 First-in-human
A Phase 1 study testing HAL-MPE1 in people with Peanut Allergy, run by HAL Allergy at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- HAL-MPE1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2014to Jun 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- HAL-MPE1, Placebo
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAL-MPE1Drug
Also called HAL-MPE1: modified peanut extract
Subcutaneous administration of increasing doses of HAL-MPE1
PlaceboDrug
Also called HAL-MPE1 placebo
Subcutaneous administration of increasing doses of placebo
| Study group | Role | What they receive |
|---|---|---|
| HAL-MPE1 | Experimental | Subcutaneous administration of increasing doses of HAL-MPE1. Receives: Drug: HAL-MPE1 |
| Placebo | Placebo comparator | Subcutaneous administration of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 20 weeks
Secondary outcomes (3)
Change in serum levels of allergen specific immunoglobulins
Measured: before and after 15-20 weeks of treatment
Change in basophil histamine release test
Measured: before and after 15-20 weeks treatment
Change in titrated skin prick test
Measured: before and after 15-20 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- HAL Allergy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carsten Bindslev-Jensen, Prof. Dr., Principal investigator, Hudafdeling I og Allergicentret, Odense Universitetshospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163018
- Sponsor's protocol ID
- HAL-MPE1/0043
- Other IDs
- 2013-004238-13
- Acronym
- HAL-MPE1/0043
- Status last verified
- Jul 2015
- First submitted
- 5 Jun 2014
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02163018
- Acronym / sponsor ID
- HAL-MPE1/0043 / HAL-MPE1/0043
- Conditions
- Peanut Allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- HAL AllergyIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAL-MPE1 | Experimental | Drug: HAL-MPE1Subcutaneous administration of increasing doses of HAL-MPE1. |
| Placebo | Placebo comparator | Drug: PlaceboSubcutaneous administration of placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAL-MPE1Also: HAL-MPE1: modified peanut extractSubcutaneous administration of increasing doses of HAL-MPE1 | Drug | HAL-MPE1 |
| PlaceboAlso: HAL-MPE1 placeboSubcutaneous administration of increasing doses of placebo | Drug | Placebo |
Primary outcome
Safety of a SCIT-treatment with HAL-MPE1 in patients with peanut allergy.
Time frame: up to 20 weeks
* 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.
3 secondary outcomes
Change in serum levels of allergen specific immunoglobulins
Time frame: before and after 15-20 weeks of treatment
Change in basophil histamine release test
Time frame: before and after 15-20 weeks treatment
Change in titrated skin prick test
Time frame: before and after 15-20 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
Related trials for Peanut Allergy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Bindslev-Jensen, Prof. Dr. principal investigator
Hudafdeling I og Allergicentret, Odense Universitetshospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HAL-MPE1 in people with Peanut Allergy, run by HAL Allergy at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of a SCIT-treatment with HAL-MPE1 in patients with peanut allergy. (time frame: up to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2015.