Rhinitis, AllergicPhase 1NCT03758456
HAL-MRE1 Subcutaneous Immunotherapy in Ragweed Allergic Patients First-in-human
A Phase 1 study testing HAL-MRE1 in people with Rhinitis, Allergic and Rhinoconjunctivitis, Allergic, run by HAL Allergy at 1 site in Canada.
Trial summary
The aim of this first-in-human phase I study is to assess the safety and tolerability of HAL-MRE1 subcutaneous immunotherapy in subjects suffering from ragweed pollen-induced allergic rhinitis/rhinoconjunctivitis with or without asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinitis, Allergic, Rhinoconjunctivitis, Allergic
- What is being tested?
- HAL-MRE1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 21 Nov 2018to 17 May 2019
- 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 and ≤65 years.
- Documented diagnosis of allergic rhinitis/rhinoconjunctivitis (ARC) to ragweed pollen. A documented diagnosis is a documented medical history of ARC symptoms that required treatment after ragweed pollen exposure. Subjects experienced allergy symptoms that required treatment during the previous 2 ragweed seasons, with or without concomitant asthma (asthma must be controlled).
- Positive nasal provocation test for ragweed pollen at screening or within the last 6 months.
- Positive skin prick test to ragweed allergen at screening or within the last 6 months.
- Positive serum specific IgE test for ragweed allergen (IgE level ≥0.7 U/mL).
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- Forced expiratory volume >70 % or peak expiratory flow >80 % of predicted value.
- For asthmatic subjects: asthma control test (ACT) score ≥20.
- Subjects are capable and willing to maintain a log of adverse events and concomitant medication throughout the study, as well as to complete a diary 24 hours post investigational medical product injection.
- 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 devices, intrauterine system implants, or vaginal rings (started at least 4 weeks prior to investigational medical product administration).
- double barrier methods e.g. condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent.
- sterilization (male or female).
- participants who are postmenopausal (12 consecutive months without a period) for at least 2 years.
- sexual abstinence or having no sexual relationship with a man.
Who cannot join
- History of anaphylaxis with cardio respiratory symptoms (food allergy, venom allergy, drugs or/and idiopathic reaction).
- Alcohol, drug or medication abuse in the past.
- Any clinically significant abnormal laboratory parameter at screening as per investigator's discretion.
- Clinically relevant sensitization to other allergens if clinical symptoms are expected during the study.
- Uncontrolled asthma.
- Participation in a clinical interventional study within the last 3 months (e.g. new investigational drug or biological), or plans to participate in another clinical trial during this study, or participation in an observational study (e.g. post marketing study) within the last 30 days unless the observational study aimed to investigate the intradermal test.
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- Subjects who received immunotherapy for any specific allergen 3 years prior to screening or during the study period.
- Subjects who were ever treated with any ragweed allergen specific immunotherapy.
- Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs.
- Subjects undergoing any immunosuppressive treatment (including anti-IgE therapy) within the last 6 months prior to inclusion in the study as well as during the study.
- Active malignancies or any malignant disease during the 5 years prior to screening.
- Severe uncontrolled diseases that, in the opinion of the investigator, 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, or hematological disorders; or severe ongoing symptomatic allergic diseases.
- Active or acute inflammation or infection of the target organs (nose, eyes) at screening.
- Diseases with a contra-indication for the use of adrenaline (e.g. hyperthyroidism, glaucoma).
- Lactation.
- Severe psychiatric, psychological, or neurological disorders.
- Subjects who have any direct working relationship with the (sub-) investigator or study site personnel or are first degree relatives or partners of the investigator or study site personnel or are employees of the sponsor.
- Known allergy or hypersensitivity to an excipient in the study drug or placebo.
- Subjects receiving the prohibited previous and concomitant medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Study to Assess the Safety and Tolerability of HAL-MRE1 Subcutaneous Immunotherapy in Adult Subjects With Ragweed Induced Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
The aim of this first-in-human phase I study is to assess the safety and tolerability of HAL-MRE1 subcutaneous immunotherapy in subjects suffering from ragweed pollen-induced allergic rhinitis/rhinoconjunctivitis with or without asthma.
The study has 4 treatment groups: 1 placebo group and 3 groups treated with different doses of HAL-MRE1.
Read the detailed description
A chemically modified, aluminum hydroxide adsorbed ragweed extract (HAL-MRE1) for subcutaneous administration was developed for the treatment of ragweed pollen-induced allergic rhinitis/rhinoconjunctivitis (ARC) with or without asthma. The aim of this first-in-human phase I study is to assess the safety and tolerability of HAL-MRE1 subcutaneous immunotherapy in subjects suffering from ragweed pollen-induced ARC with or without asthma.
The study will consist of 3 staggered cohorts of 15 subjects each who are randomly assigned to the active or placebo group in a 2:1 manner using block randomization.
A one month gap must be maintained between the end of the ragweed pollen peak season (2018) and subject randomization into the study. The study has seasonal constraints; subjects with concomitant tree and/or grass pollen allergies must complete study treatment before any allergy symptoms due to tree and/or grass pollen exposure develop or start study treatment after the symptoms caused by the tree and/or grass pollen exposure have disappeared.
- Conditions
- Rhinitis, Allergic, Rhinoconjunctivitis, Allergic
- Being tested
- HAL-MRE1
- Keywords
- Subcutaneous immunotherapy, Ragweed pollen, Allergic rhinitis/rhinoconjunctivitis, Safety, Tolerability
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAL-MRE1Biological
HAL-MRE1 is a liquid suspension for subcutaneous administration containing aluminum hydroxide adsorbed modified allergens extracted from ragweed pollen.
| Study group | Role | What they receive |
|---|---|---|
| HAL-MRE1 0 AUeq | Placebo comparator | 15 subjects will receive placebo. Subjects will receive 7-9 incremental weekly injections. All doses will be subcutaneously injected in a double-blind fashion in the upper arm. Receives: Biological: HAL-MRE1 |
| HAL-MRE1 5,000 AUeq | Experimental | 10 subjects will receive HAL-MRE1 5,000 AUeq. Subjects will receive 6-8 incremental weekly injections until reaching the maximum dose of 5,000 AUeq. Subsequently, 1 repeated maximum dose injection will be given 1 week later (total treatment period will be approximately 7-9 weeks). All doses will be subcutaneously injected in a double-blind fashion in the upper arm. Receives: Biological: HAL-MRE1 |
| HAL-MRE1 10,000 AUeq | Experimental | 10 patients will receive HAL-MRE1 10,000 AUeq. Subjects will receive 6-8 incremental weekly injections until reaching the maximum dose of 10,000 AUeq. Subsequently, 1 repeated maximum dose injection will be given 1 week later (total treatment period will be approximately 7-9 weeks). All doses will be subcutaneously injected in a double-blind fashion in the upper arm. Receives: Biological: HAL-MRE1 |
| HAL-MRE1 20,000 AUeq | Experimental | 10 patients will receive HAL-MRE1 20,000 AUeq. Subjects will receive 6-8 incremental weekly injections until reaching the maximum dose of 20,000 AUeq. Subsequently, 1 repeated maximum dose injection will be given 1 week later (total treatment period will be approximately 7-9 year). All doses will be subcutaneously injected in a double-blind fashion in the upper arm. Receives: Biological: HAL-MRE1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of local and systemic reactions
Number, intensity and seriousness of early (within 30 mins from injection), delayed (within 30mins and 3 hours from injection) and late (from 3 hours to 24 hours after injection) local reactions (>8 cm wheal size swelling at injection site) as well as early, delayed and late systemic reactions.
Measured: Through study completion, approximately 10 weeks
Secondary outcomes (6)
Occurence of other local reactions
Number, intensity and seriousness of other local reactions like itching, pain and redness at injection site.
Measured: Through study completion, approximately 10 weeks
Occurrence of treatment emergent adverse events
Treatment emergent adverse events will be collected by reporting of adverse events and by clinical relevant changes in e.g. laboratory values, vital signs, physical exam, and lung function in plasma and urine
Measured: Through study completion, approximately of 10 weeks
Number of subjects that reach maximum dose
The number of subjects in each cohort who reach the maximum dose is indicative of HAL-MRE1 tolerability.
Measured: Through study completion, approximately of 10 weeks
Number of injections to reach maintenance dose
The number of injections that subjects in each cohort need to reach the maximum dose will provide an indication of HAL-MRE1 tolerability.
Measured: Through study completion, approximately of 10 weeks
Immunoglobulin Levels
Short term pharmacodynamic effects of HAL-MRE1 will be measured by determining the change in serum levels of allergen specific immunoglobulins (IgE, IgG and IgG4) pre- and post-study treatment in the HAL-MRE versus placebo treated groups.
Measured: Pre-treatment and after the repeated maintenance dose visit (after 8 to 10 weeks)
Change in wheal size after skin prick test
Exploratory efficacy data will be obtained by measuring the change in wheal size following skin prick test with ragweed extract pre- and post-treatment in the HAL-MRE1 versus placebo treated groups.
Measured: Pre-treatment and after the repeated maintenance dose visit (after 8 to 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start21 Nov 2018
- Primary completion17 May 2019
- Study completion17 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, AllergicStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- HAL Allergy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Couroux, MD, Principal investigator, Inflamax Research Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758456
- Sponsor's protocol ID
- HAL-MRE1/PR0051
- Status last verified
- Aug 2019
- First submitted
- 7 Nov 2018
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Study to Assess the Safety and Tolerability of HAL-MRE1 Subcutaneous Immunotherapy in Adult Subjects With Ragweed Induced Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
- ClinicalTrials.gov ID
- NCT03758456
- Acronym / sponsor ID
- HAL-MRE1/PR0051
- Conditions
- Rhinitis, Allergic, Rhinoconjunctivitis, Allergic
- Keywords
- Subcutaneous immunotherapy, Ragweed pollen, Allergic rhinitis/rhinoconjunctivitis, Safety, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- HAL AllergyIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 29 Nov 2018 (actual)
- 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.
The aim of this first-in-human phase I study is to assess the safety and tolerability of HAL-MRE1 subcutaneous immunotherapy in subjects suffering from ragweed pollen-induced allergic rhinitis/rhinoconjunctivitis with or without asthma.
The study has 4 treatment groups: 1 placebo group and 3 groups treated with different doses of HAL-MRE1.
Detailed description
A chemically modified, aluminum hydroxide adsorbed ragweed extract (HAL-MRE1) for subcutaneous administration was developed for the treatment of ragweed pollen-induced allergic rhinitis/rhinoconjunctivitis (ARC) with or without asthma. The aim of this first-in-human phase I study is to assess the safety and tolerability of HAL-MRE1 subcutaneous immunotherapy in subjects suffering from ragweed pollen-induced ARC with or without asthma.
The study will consist of 3 staggered cohorts of 15 subjects each who are randomly assigned to the active or placebo group in a 2:1 manner using block randomization.
A one month gap must be maintained between the end of the ragweed pollen peak season (2018) and subject randomization into the study. The study has seasonal constraints; subjects with concomitant tree and/or grass pollen allergies must complete study treatment before any allergy symptoms due to tree and/or grass pollen exposure develop or start study treatment after the symptoms caused by the tree and/or grass pollen exposure have disappeared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HAL-MRE1 0 AUeq | Placebo comparator | Biological: HAL-MRE115 subjects will receive placebo. Subjects will receive 7-9 incremental weekly injections. All doses will be subcutaneously injected in a double-blind fashion in the upper arm. |
| HAL-MRE1 5,000 AUeq | Experimental | Biological: HAL-MRE110 subjects will receive HAL-MRE1 5,000 AUeq. Subjects will receive 6-8 incremental weekly injections until reaching the maximum dose of 5,000 AUeq. Subsequently, 1 repeated maximum dose injection will be given 1 week later (total treatment period will be approximately 7-9 weeks). All doses will be subcutaneously injected in a double-blind fashion in the upper arm. |
| HAL-MRE1 10,000 AUeq | Experimental | Biological: HAL-MRE110 patients will receive HAL-MRE1 10,000 AUeq. Subjects will receive 6-8 incremental weekly injections until reaching the maximum dose of 10,000 AUeq. Subsequently, 1 repeated maximum dose injection will be given 1 week later (total treatment period will be approximately 7-9 weeks). All doses will be subcutaneously injected in a double-blind fashion in the upper arm. |
| HAL-MRE1 20,000 AUeq | Experimental | Biological: HAL-MRE110 patients will receive HAL-MRE1 20,000 AUeq. Subjects will receive 6-8 incremental weekly injections until reaching the maximum dose of 20,000 AUeq. Subsequently, 1 repeated maximum dose injection will be given 1 week later (total treatment period will be approximately 7-9 year). All doses will be subcutaneously injected in a double-blind fashion in the upper arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed informed consent.
- Male or female subjects aged ≥18 and ≤65 years.
- Documented diagnosis of allergic rhinitis/rhinoconjunctivitis (ARC) to ragweed pollen. A documented diagnosis is a documented medical history of ARC symptoms that required treatment after ragweed pollen exposure. Subjects experienced allergy symptoms that required treatment during the previous 2 ragweed seasons, with or without concomitant asthma (asthma must be controlled).
- Positive nasal provocation test for ragweed pollen at screening or within the last 6 months.
- Positive skin prick test to ragweed allergen at screening or within the last 6 months.
Key exclusion criteria (19 listed)
- History of anaphylaxis with cardio respiratory symptoms (food allergy, venom allergy, drugs or/and idiopathic reaction).
- Alcohol, drug or medication abuse in the past.
- Any clinically significant abnormal laboratory parameter at screening as per investigator's discretion.
- Clinically relevant sensitization to other allergens if clinical symptoms are expected during the study.
- Uncontrolled asthma.
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-MRE1HAL-MRE1 is a liquid suspension for subcutaneous administration containing aluminum hydroxide adsorbed modified allergens extracted from ragweed pollen. | Biological | HAL-MRE1 0 AUeq, HAL-MRE1 10,000 AUeq, HAL-MRE1 20,000 AUeq, HAL-MRE1 5,000 AUeq |
Primary outcome
Occurence of local and systemic reactions
Time frame: Through study completion, approximately 10 weeks
Number, intensity and seriousness of early (within 30 mins from injection), delayed (within 30mins and 3 hours from injection) and late (from 3 hours to 24 hours after injection) local reactions (>8 cm wheal size swelling at injection site) as well as early, delayed and late systemic reactions.
6 secondary outcomes
Occurence of other local reactions
Time frame: Through study completion, approximately 10 weeks
Occurrence of treatment emergent adverse events
Time frame: Through study completion, approximately of 10 weeks
Number of subjects that reach maximum dose
Time frame: Through study completion, approximately of 10 weeks
Number of injections to reach maintenance dose
Time frame: Through study completion, approximately of 10 weeks
Immunoglobulin Levels
Time frame: Pre-treatment and after the repeated maintenance dose visit (after 8 to 10 weeks)
Change in wheal size after skin prick test
Time frame: Pre-treatment and after the repeated maintenance dose visit (after 8 to 10 weeks)
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 6 Aug 2019.
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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.
Peter Couroux, MD principal investigator
Inflamax Research Ltd.
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-MRE1 in people with Rhinitis, Allergic and Rhinoconjunctivitis, Allergic, run by HAL Allergy at 1 site in Canada.
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 16 inclusion and 19 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 6 Aug 2019. 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 Canada. 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?
Occurence of local and systemic reactions (time frame: Through study completion, approximately 10 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 6 Aug 2019.