Birch Pollen AllergyPhase 1BM41NCT04912076
S.C. Immunotherapy With BM41 in Patients With Allergic Rhino-conjunctivitis Caused by Birch Pollen
A Phase 1 study testing BM41 and ALK Alutard SQ Betula verrucosa in people with Birch Pollen Allergy and Allergic Rhinoconjunctivitis, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The aim of this clinical phase I single centre, randomized, double-blind, placebo-controlled study with open comparator is to investigate tolerability and safety as well as the immunological effects of BM41 in comparison to placebo (double blind) and to a standard subcutaneous immunotherapy Alutard SQ (open) in birch… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Birch Pollen Allergy, Allergic Rhinoconjunctivitis
- What is being tested?
- BM41 and ALK Alutard SQ Betula verrucosa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Sep 2018to 22 Mar 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
- Age ≥18 ≤ 65 years
- Moderate to severe birch-pollen-induced allergic rhinitis/rhinoconjunctivitis of at least 2 years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines (Appendix 1, see the manual of procedures) with or without concomitant mild to moderate persistent asthma
- Forced expiratory volume (FEV1) >70% for patients with a history of asthma, FEV1>70% or peak flow (PEF) >80% for patients without a history of asthma
- A positive skin prick test (SPT) (mean wheal diameter ≥ 3mm compared to negative control and negative control should be negative) for birch pollen assessed within 1 year before randomization
- Specific IgE against birch pollen extract ≥ 0.7 kU/L and against Bet v 1 ≥ 0.35 kU/L as determined by ImmunoCAP
Who cannot join
- Chronic asthma with an FEV1<70 % of predicted value.
- History of allergen immunotherapy (AIT) (subcutaneous (SCIT) or sublingual (SLIT)) with birch pollen or tree pollen mix including birch pollen within the past 5 years
- Ongoing AIT (SCIT or SLIT) with any allergen(s) during the study period
- Vaccination within one week before or during the treatment phase.
- Immunosuppressive or biological medication (e.g. IL-5, anti-IgE therapy) within the last six months prior to inclusion and up to end of trial (EoT).
- Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs.
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- Uncontrolled asthma or other active respiratory diseases.
- Active malignancies or any malignant disease during the previous 5 years.
- Severe uncontrolled diseases that could increase the risk for patients participating in the study, including but not limited to: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or haematological disorders.
- Renal insufficiency
- Active inflammation or infection of the target organs (nose, eyes or lower airways) at the start of the study.
- 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 systemic and local β-blockers.
- Known allergy towards constituents of the vaccine
- Pregnancy, lactation or inadequate contraceptive measures for women of child-bearing age (adequate contraceptive measures will be intrauterine device or hormonal contraception (birth control pill, implant, transdermal patch, vaginal ring or depot injection). It is also accepted, if the female patient is permanently sterile or infertile, if her sole partner is permanently sterile, or if they use both condom and diaphragm, The definition of sterile or infertile is surgically sterilized (vasectomy/bilateral salpingectomy, hysterectomy and/or bilateral ovariectomy) or post menopause defined as a non-menstrual period of at least 12 months before inclusion in the study.
- Alcohol, drug or medication abuse within the past year.
- Any clinically significant abnormal laboratory parameter at screening.
- Lack of cooperation or compliance.
- Any physical or mental condition that precludes administration of SCIT, compliance or participation in a clinical trial.
- Patients who are students or employees of the institution or 1st grade relatives or partners of the investigators
- Participation in a clinical trial within 3 months prior to the current trial.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Odense Research Center for Anaphylaxis, Odense University Hospital
Odense, 5000
About this study
Official title: A Randomized, DBPC Study to Determine the Safety, Tolerability and Immunological Effects of BM41 Compared to Placebo and to Treatment With Standard s.c. Immunotherapy in Patients Allergic to Birch Pollen
The aim of this clinical phase I single centre, randomized, double-blind, placebo-controlled study with open comparator is to investigate tolerability and safety as well as the immunological effects of BM41 in comparison to placebo (double blind) and to a standard subcutaneous immunotherapy Alutard SQ (open) in birch allergic patients.
Read the detailed description
Please see original article.
- Conditions
- Birch Pollen Allergy, Allergic Rhinoconjunctivitis
- Being tested
- BM41, Placebo, ALK Alutard SQ Betula verrucosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BM41Drug
Subcutaneous injection of increasing doses of BM41
PlaceboOther
Subcutaneous injections of placebo containing aluminium hydroxide.
ALK Alutard SQ Betula verrucosaDrug
Subcutaneous injections with increasing doses of Alutard according to cluster up-dosing scheme.
| Study group | Role | What they receive |
|---|---|---|
| BM41 | Experimental | 9 treatment visits where subcutaneous injections with solution of the test drug BM41 (adsorbed to aluminium hydroxide) in a blinded fashion starting with 12.5 nanogram increasing to 20 microgram which is maintenance dose. Subsequently 3 maintenance doses will be given.
Please look at the results in the original article. Receives: Drug: BM41 |
| Placebo | Placebo comparator | Placebo consisting of only aluminium hydroxide will be administered blinded in amounts according to BM41. Receives: Other: Placebo |
| Alutard | Active comparator | Alutard SQ (ALK) will serve as the comparator and administration is open. Up-dosing is performed according to the official cluster scheme, reaching maintenance of 100.000 SQ-E Receives: Drug: ALK Alutard SQ Betula verrucosa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events with emphasis on allergic reactions. Safety/tolerability of subcutaneous treatment with BM41 compared to placebo (double-blind) and to a conventional standardized birch pollen extract in patients with birch pollen allergy
Safety/tolerability of subcutaneous treatment with BM41 compared to placebo (double-blind) and to a conventional standardized birch pollen extract.
Number and character of all adverse events will be evaluated.
Measured: Through study completion, an average of 4 months
Secondary outcomes (4)
Changes in serum immunoglobulin E (IgE), immunoglobulin G (IgG) and immunoglobulin G4 (IgG4) levels.
Evaluation of immunological responses during subcutaneous allergen immunotherapy (SCIT) with BM41 compared to placebo and to a conventional, standardized and registered birch pollen extract (Alutard SQ).The evaluation will be done by monitoring changes in serum immunoglobulin E (IgE), immunoglobulin G (IgG) and immunoglobulin G4 (IgG4) levels against recombinant Bet v 1 (rBet v 1), BM41 and birch pollen extract. Serum will also be used in a so-called IgE facilitated allergen-binding assay (FAB) and in a rat basophilic leukemia cell (RBL)-based histamine release test, to monitor the functional blocking antibody capacity of induced IgG/IgG4 antibodies.
Measured: Day 7, 42 and 126
Epigenetic changes induced by BM41 and Alutard compared to placebo
DNA will be isolated from a blood sample.
Measured: Day 7, 42 and 126
Changes in wheal sizes upon titrated skin prick test with BM41.
Evaluation of hypo-allergenicity before first exposure but also during repeated exposure to BM41.
Measured: Day 7, 42 and 112
Changes in the capacity to block IgE facilitated allergen binding and histamine release.
It will be evaluated in an IgE facilitated allergen binding (FAB) assay and in a rat basophilic leukemia cell (RBL)-based histamine release test.
Measured: Day 7, 42 and 126
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start17 Sep 2018
- Primary completion22 Mar 2019
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birch Pollen AllergyStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Model description
- A randomized, double-blind, placebo-controlled, single centre Phase I study with an open comparator group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Biomay AG, European Commission, University of Salzburg
- Responsible party
- Principal investigator, Carsten Bindslev-Jensen, Odense University Hospital
- Investigators
- Carsten Bindslev-Jensen, Professor, Principal investigator, Odense research Center for Anaphylaxis, Odense University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912076
- Sponsor's protocol ID
- 2018-001486-17
- Other IDs
- 2018
- Acronym
- BM41
- Status last verified
- Dec 2023
- First submitted
- 24 May 2021
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, DBPC Study to Determine the Safety, Tolerability and Immunological Effects of BM41 Compared to Placebo and to Treatment With Standard s.c. Immunotherapy in Patients Allergic to Birch Pollen
- ClinicalTrials.gov ID
- NCT04912076
- Acronym / sponsor ID
- BM41 / 2018-001486-17
- Conditions
- Birch Pollen Allergy, Allergic Rhinoconjunctivitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Biomay AG, European Commission, University of Salzburg
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 3 Jun 2021 (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 clinical phase I single centre, randomized, double-blind, placebo-controlled study with open comparator is to investigate tolerability and safety as well as the immunological effects of BM41 in comparison to placebo (double blind) and to a standard subcutaneous immunotherapy Alutard SQ (open) in birch allergic patients.
Detailed description
Please see original article.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized, double-blind, placebo-controlled, single centre Phase I study with an open comparator group
| Arm | Type | Receives |
|---|---|---|
| BM41 | Experimental | Drug: BM419 treatment visits where subcutaneous injections with solution of the test drug BM41 (adsorbed to aluminium hydroxide) in a blinded fashion starting with 12.5 nanogram increasing to 20 microgram which is maintenance dose. Subsequently 3 maintenance doses will be given. Please look at the results in the original article. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo consisting of only aluminium hydroxide will be administered blinded in amounts according to BM41. |
| Alutard | Active comparator | Drug: ALK Alutard SQ Betula verrucosaAlutard SQ (ALK) will serve as the comparator and administration is open. Up-dosing is performed according to the official cluster scheme, reaching maintenance of 100.000 SQ-E |
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
- Age ≥18 ≤ 65 years
- Moderate to severe birch-pollen-induced allergic rhinitis/rhinoconjunctivitis of at least 2 years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines (Appendix 1, see the manual of procedures) with or without concomitant mild to moderate persistent asthma
- Forced expiratory volume (FEV1) >70% for patients with a history of asthma, FEV1>70% or peak flow (PEF) >80% for patients without a history of asthma
- A positive skin prick test (SPT) (mean wheal diameter ≥ 3mm compared to negative control and negative control should be negative) for birch pollen assessed within 1 year before randomization
Key exclusion criteria (22 listed)
- Chronic asthma with an FEV1<70 % of predicted value.
- History of allergen immunotherapy (AIT) (subcutaneous (SCIT) or sublingual (SLIT)) with birch pollen or tree pollen mix including birch pollen within the past 5 years
- Ongoing AIT (SCIT or SLIT) with any allergen(s) during the study period
- Vaccination within one week before or during the treatment phase.
- Immunosuppressive or biological medication (e.g. IL-5, anti-IgE therapy) within the last six months prior to inclusion and up to end of trial (EoT).
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 |
|---|---|---|
| BM41Subcutaneous injection of increasing doses of BM41 | Drug | BM41 |
| PlaceboSubcutaneous injections of placebo containing aluminium hydroxide. | Other | Placebo |
| ALK Alutard SQ Betula verrucosaSubcutaneous injections with increasing doses of Alutard according to cluster up-dosing scheme. | Drug | Alutard |
Primary outcome
Incidence of adverse events with emphasis on allergic reactions. Safety/tolerability of subcutaneous treatment with BM41 compared to placebo (double-blind) and to a conventional standardized birch pollen extract in patients with birch pollen allergy
Time frame: Through study completion, an average of 4 months
Safety/tolerability of subcutaneous treatment with BM41 compared to placebo (double-blind) and to a conventional standardized birch pollen extract. Number and character of all adverse events will be evaluated.
4 secondary outcomes
Changes in serum immunoglobulin E (IgE), immunoglobulin G (IgG) and immunoglobulin G4 (IgG4) levels.
Time frame: Day 7, 42 and 126
Epigenetic changes induced by BM41 and Alutard compared to placebo
Time frame: Day 7, 42 and 126
Changes in wheal sizes upon titrated skin prick test with BM41.
Time frame: Day 7, 42 and 112
Changes in the capacity to block IgE facilitated allergen binding and histamine release.
Time frame: Day 7, 42 and 126
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 11 Dec 2023.
- Individual participant dataSharing planned: No
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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, Professor principal investigator
Odense research Center for Anaphylaxis, Odense University Hospital, Denmark
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 BM41 and ALK Alutard SQ Betula verrucosa in people with Birch Pollen Allergy and Allergic Rhinoconjunctivitis, run by Odense University Hospital 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 22 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 11 Dec 2023. 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?
Incidence of adverse events with emphasis on allergic reactions. Safety/tolerability of subcutaneous treatment with BM41 compared to placebo (double-blind) and to a conventional standardized birch pollen extract in patients with birch pollen allergy (time frame: Through study completion, an average of 4 months). 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 11 Dec 2023.