Birch Pollen AllergyPhase 1NCT04266028
Study to Evaluate Safety and Tolerability of sc Immunotherapy With DM-101 in Adults With Birch Pollen Allergy
A Phase 1 study testing DM-101 in people with Birch Pollen Allergy, run by Desentum Oy at 1 site in Finland.
Trial summary
Randomized, double-blind placebo-controlled phase I study to investigate the safety and tolerability of ascending doses of DM-101 in adult subjects with birch pollen allergy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Birch Pollen Allergy
- What is being tested?
- DM-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteFinland
- Study dates
- 11 Feb 2020to 31 May 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males or females, aged 18 to 65 years
- Good general health
- A documented clinical history of birch pollen-induced allergic rhinitis or rhinoconjunctivitis with symptoms that interfere with daily activities or sleep and remain bothersome despite the use of relevant symptomatic medication, and have been present over, at least, 2 allergy seasons.
- Bet v 1 specific serum IgE ≥ 0.7 kU/L
- Positive SPT to birch pollen allergen, with a wheal diameter ≥ 5 mm
- Body weight ≥50 kg and body mass index (BMI) within the range 18-35 kg/m2.
Who cannot join
- History or findings on physical examination of any significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, influence the results of the study or the subject's ability to participate in the study.
- Current diagnosis of asthma (other than seasonal during the birch pollen allergy season), requiring Global Initiative for Asthma (GINA) Step 2 or higher treatment, or asthma partially controlled or uncontrolled according to GINA classification in the 6 months before Screening.
- History of asthma deterioration that resulted in emergency treatment or hospitalisation in the 12 months before screening, or a life-threatening asthma attack at any time in the past.
- Forced Expiratory Volume in one second (FEV1) < 70% of predicted, regardless of asthma status at screening or baseline assessment at the first dosing visit.
- History of severe drug allergy, severe angioedema or systemic allergic reaction of Grade 3 or greater, according to the World Allergy Organization (WAO) scale, due to any cause.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety and Tolerability of Subcutaneous Immunotherapy With DM-101 in Adults With Birch Pollen Allergy
Randomized, double-blind placebo-controlled phase I study to investigate the safety and tolerability of ascending doses of DM-101 in adult subjects with birch pollen allergy.
Read the detailed description
The study will be carried out in a single study site located in Finland.
- Conditions
- Birch Pollen Allergy
- Being tested
- DM-101, Placebo to match DM-101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DM-101Biological
DM-101 administered by subcutaneous (SC) injection
Placebo to match DM-101Biological
Placebo to match DM-101 administered by SC injection
| Study group | Role | What they receive |
|---|---|---|
| DM-101 Single Dose | Experimental | Participants received a single subcutaneous (SC) dose of DM-101 30 ng on Day 1 Receives: Biological: DM-101 |
| Placebo Single Dose | Placebo comparator | Participants received a single SC injection of placebo on Day 1 Receives: Biological: Placebo to match DM-101 |
| DM-101 Low Multiple Ascending Doses (MAD) | Experimental | Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 42, and 56. Receives: Biological: DM-101 |
| Placebo Low MAD | Placebo comparator | Participants received 5 biweekly administered SC injections of placebo on Day 1,14, 28, 42, and 56. Receives: Biological: Placebo to match DM-101 |
| DM-101 High MAD | Experimental | Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 200 ng (dose divided into two SC injections) on Day 42, and 300 ng (dose divided into three SC injections) on Day 56. Receives: Biological: DM-101 |
| Placebo High MAD | Placebo comparator | Participants received 5 biweekly administered SC injections of placebo as follows: single injection on Day 1, 14 and 28; two injections on Day 42; three injections on Day 56. Receives: Biological: Placebo to match DM-101 |
| DM-101 2-Day Ultra-Rush Dose Escalation | Experimental | Participants received 9 SC doses of DM-101 as follows: 100, 250, 500, 1000, 2500, 5000, 10000 and 25000 ng during Day 1 and Day 2. Receives: Biological: DM-101 |
| Placebo 2-Day Ultra-Rush Dose Escalation | Placebo comparator | Participants received 9 SC injections of placebo during Day 1 and Day 2. Receives: Biological: Placebo to match DM-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events
Number of All Treatment Emergent Adverse Events (TEAEs) in Subjects Receiving DM-101 Compared to Placebo
Measured: From the first dose until 28 days following the last dose.
Secondary outcomes (3)
Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo
Severity of SARs are graded from Grade 1 to 5 (Grade 5 being fatal) as defined by WAO Subcutaneous Immunotherapy Systemic Reaction Grading System.
Measured: From the first dose until 28 days following the last dose.
Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo
Pain, tenderness, erythema/redness and induration/swelling at the injection site was assessed after each injection using a 4-point scale (Grade 1 = mild, Grade 4 = severe) as defined in the study protocol.
Measured: From the first dose until 28 days following the last dose.
Subjects Reaching the Pre-defined DM-101 Dose
Proportion of subjects reaching the pre-defined, admissible dose in each DM-101 dosing group
Measured: From the first dose until 28 days following the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start11 Feb 2020
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Birch Pollen 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 4 sequential study cohorts with ascending DM-101 doses. In each cohort two treatment arms: placebo and active drug
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Desentum Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Nilson, Study director, Desentum OyMika Scheinin, Principal investigator, Clinical Research Services Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266028
- Sponsor's protocol ID
- DM-101-C-001
- Other IDs
- 2019-001936-67, 2019
- Status last verified
- Jun 2021
- First submitted
- 10 Feb 2020
- Last updated
- 21 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety and Tolerability of Subcutaneous Immunotherapy With DM-101 in Adults With Birch Pollen Allergy
- ClinicalTrials.gov ID
- NCT04266028
- Acronym / sponsor ID
- DM-101-C-001
- Conditions
- Birch Pollen Allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Desentum OyIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Posted 21 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-blind placebo-controlled phase I study to investigate the safety and tolerability of ascending doses of DM-101 in adult subjects with birch pollen allergy.
Detailed description
The study will be carried out in a single study site located in Finland.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
- Model description
- 4 sequential study cohorts with ascending DM-101 doses. In each cohort two treatment arms: placebo and active drug
| Arm | Type | Receives |
|---|---|---|
| DM-101 Single Dose | Experimental | Biological: DM-101Participants received a single subcutaneous (SC) dose of DM-101 30 ng on Day 1 |
| Placebo Single Dose | Placebo comparator | Biological: Placebo to match DM-101Participants received a single SC injection of placebo on Day 1 |
| DM-101 Low Multiple Ascending Doses (MAD) | Experimental | Biological: DM-101Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 42, and 56. |
| Placebo Low MAD | Placebo comparator | Biological: Placebo to match DM-101Participants received 5 biweekly administered SC injections of placebo on Day 1,14, 28, 42, and 56. |
| DM-101 High MAD | Experimental | Biological: DM-101Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 200 ng (dose divided into two SC injections) on Day 42, and 300 ng (dose divided into three SC injections) on Day 56. |
| Placebo High MAD | Placebo comparator | Biological: Placebo to match DM-101Participants received 5 biweekly administered SC injections of placebo as follows: single injection on Day 1, 14 and 28; two injections on Day 42; three injections on Day 56. |
| DM-101 2-Day Ultra-Rush Dose Escalation | Experimental | Biological: DM-101Participants received 9 SC doses of DM-101 as follows: 100, 250, 500, 1000, 2500, 5000, 10000 and 25000 ng during Day 1 and Day 2. |
| Placebo 2-Day Ultra-Rush Dose Escalation | Placebo comparator | Biological: Placebo to match DM-101Participants received 9 SC injections of placebo during Day 1 and Day 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females, aged 18 to 65 years
- Good general health
- A documented clinical history of birch pollen-induced allergic rhinitis or rhinoconjunctivitis with symptoms that interfere with daily activities or sleep and remain bothersome despite the use of relevant symptomatic medication, and have been present over, at least, 2 allergy seasons.
- Bet v 1 specific serum IgE ≥ 0.7 kU/L
- Positive SPT to birch pollen allergen, with a wheal diameter ≥ 5 mm
Key exclusion criteria (5 listed)
- History or findings on physical examination of any significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, influence the results of the study or the subject's ability to participate in the study.
- Current diagnosis of asthma (other than seasonal during the birch pollen allergy season), requiring Global Initiative for Asthma (GINA) Step 2 or higher treatment, or asthma partially controlled or uncontrolled according to GINA classification in the 6 months before Screening.
- History of asthma deterioration that resulted in emergency treatment or hospitalisation in the 12 months before screening, or a life-threatening asthma attack at any time in the past.
- Forced Expiratory Volume in one second (FEV1) < 70% of predicted, regardless of asthma status at screening or baseline assessment at the first dosing visit.
- History of severe drug allergy, severe angioedema or systemic allergic reaction of Grade 3 or greater, according to the World Allergy Organization (WAO) scale, due to any cause.
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 |
|---|---|---|
| DM-101DM-101 administered by subcutaneous (SC) injection | Biological | DM-101 2-Day Ultra-Rush Dose Escalation, DM-101 High MAD, DM-101 Low Multiple Ascending Doses (MAD), DM-101 Single Dose |
| Placebo to match DM-101Placebo to match DM-101 administered by SC injection | Biological | Placebo 2-Day Ultra-Rush Dose Escalation, Placebo High MAD, Placebo Low MAD, Placebo Single Dose |
Primary outcome
Treatment Emergent Adverse Events
Time frame: From the first dose until 28 days following the last dose.
Number of All Treatment Emergent Adverse Events (TEAEs) in Subjects Receiving DM-101 Compared to Placebo
3 secondary outcomes
Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo
Time frame: From the first dose until 28 days following the last dose.
Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo
Time frame: From the first dose until 28 days following the last dose.
Subjects Reaching the Pre-defined DM-101 Dose
Time frame: From the first dose until 28 days following the last dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie publicly available results will be considered for sharing
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Evaluation of the Efficacy of Oral Immunotherapy With Raw Apple in Patients Allergic to Birch Pollen and Apple: Prospective, Multicenter, Comparative Phase III Study
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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.
Anna Nilson study director
Desentum Oy
Mika Scheinin principal investigator
Clinical Research Services Turku
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 DM-101 in people with Birch Pollen Allergy, run by Desentum Oy at 1 site in Finland.
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 5 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 21 Mar 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 Finland. 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?
Yes. Results are posted in the registry (first posted 21 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Emergent Adverse Events (time frame: From the first dose until 28 days following the last dose.). 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 21 Mar 2023.