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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001936-67 | EudraCT Number |
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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.
The study will be carried out in a single study site located in Finland.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DM-101 Single Dose | Experimental | Participants received a single subcutaneous (SC) dose of DM-101 30 ng on Day 1 |
|
| Placebo Single Dose | Placebo Comparator | Participants received a single SC injection of placebo on Day 1 |
|
| 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. |
|
| Placebo Low MAD | Placebo Comparator | Participants received 5 biweekly administered SC injections of placebo on Day 1,14, 28, 42, and 56. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DM-101 | Biological | DM-101 administered by subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Emergent Adverse Events | Number of All Treatment Emergent Adverse Events (TEAEs) in Subjects Receiving DM-101 Compared to Placebo | From the first dose until 28 days following the last dose. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the first dose until 28 days following the last dose. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Nilson | Desentum Oy | Study Director |
| Mika Scheinin | Clinical Research Services Turku | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Services Turku | Turku | Finland |
All individual participant data that underlie publicly available results will be considered for sharing
Anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Qualified researchers may request access to patient level data and related study documents. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants after Desentum has received marketing authorization from major health authorities (e.g., FDA, EMA), has the legal authority to share the data, and has made the study results publicly available.
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61 participants were screened.
Participants were enrolled at one study site in Finland. The first participant was screened 11 February 2020. The last study visit occurred on 31 Mat 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | DM-101 Single Dose | Participants received a single subcutaneous (SC) dose of DM-101 30 ng on Day 1. |
| FG001 | Placebo Single Dose | Participants received a single SC injection of placebo on Day 1. |
| FG002 | DM-101 Low Multiple Ascending Doses (MAD) | 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. |
| FG003 | Placebo Low MAD | Participants received 5 biweekly administered SC injections of placebo on Day 1,14, 28, 42, and 56. |
| FG004 | DM-101 High MAD | 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. |
| FG005 | Placebo High MAD | 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. |
| FG006 | DM-101 2-Day Ultra-Rush Dose Escalation | 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. |
| FG007 | Placebo 2-Day Ultra-Rush Dose Escalation | Participants received 9 SC injections of placebo during Day 1 and Day 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety Analysis Set included participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | DM-101 Single Dose | Participants received a single subcutaneous (SC) dose of DM-101 30 ng on Day 1. |
| BG001 | Placebo Single Dose | Participants received a single SC injection of placebo on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Emergent Adverse Events | Number of All Treatment Emergent Adverse Events (TEAEs) in Subjects Receiving DM-101 Compared to Placebo | The Safety Set included participants who received at least 1 dose of study drug. | Posted | Number | number of adverse events per arm | From the first dose until 28 days following the last dose. |
|
From the first dose until 28 days following the last dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DM-101 Single Dose | Participants received a single subcutaneous (SC) dose of DM-101 30 ng on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian Cyst Ruptured | Reproductive system and breast disorders | MedDra 23.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leucocytosis | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Operations | Desentum Oy | +358400224892 | Info@desentum.fi |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2021 | Jun 7, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 6, 2021 | Jun 7, 2022 | SAP_001.pdf |
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4 sequential study cohorts with ascending DM-101 doses. In each cohort two treatment arms: placebo and active drug
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| 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. |
|
| 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. |
|
| Placebo 2-Day Ultra-Rush Dose Escalation | Placebo Comparator | Participants received 9 SC injections of placebo during Day 1 and Day 2. |
|
| Placebo to match DM-101 | Biological | Placebo to match DM-101 administered by SC injection |
|
| 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. |
| 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 | From the first dose until 28 days following the last dose. |
| temporary halt of the study |
|
| Onset of birch pollen season |
|
| BG002 | DM-101 Low Multiple Ascending Doses (MAD) | 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. |
| BG003 | Placebo Low MAD | Participants received 5 biweekly administered SC injections of placebo on Day 1,14, 28, 42, and 56. |
| BG004 | DM-101 High MAD | 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. |
| BG005 | Placebo High MAD | 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. |
| BG006 | DM-101 2-Day Ultra-Rush Dose Escalation | 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. |
| BG007 | Placebo 2-Day Ultra-Rush Dose Escalation | Participants received 9 SC injections of placebo during Day 1 and Day 2. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| DM-101 Low Multiple Ascending Doses (MAD) |
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. |
| OG003 | Placebo Low MAD | Participants received 5 biweekly administered SC injections of placebo on Day 1,14, 28, 42, and 56. |
| OG004 | DM-101 High MAD | 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. |
| OG005 | Placebo High MAD | 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. |
| OG006 | DM-101 2-Day Ultra-Rush Dose Escalation | 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. |
| OG007 | Placebo 2-Day Ultra-Rush Dose Escalation | Participants received 9 SC injections of placebo during Day 1 and Day 2. |
|
|
|
| Secondary | 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. | The Safety Analysis Set included participants who received at least 1 dose of study drug. | Posted | Number | number of systemic reactions per arm | From the first dose until 28 days following the last dose. |
|
|
|
| Secondary | 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. | The Safety Analysis Set included all participants who received at least 1 dose of study drug. | Posted | Number | number of LISRs per arm | From the first dose until 28 days following the last dose. |
|
|
|
| Secondary | Subjects Reaching the Pre-defined DM-101 Dose | Proportion of subjects reaching the pre-defined, admissible dose in each DM-101 dosing group | The Safety Analysis Set included participants who received at least 1 dose of study drug | Posted | Count of Participants | Participants | From the first dose until 28 days following the last dose. |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | Placebo Single Dose | Participants received a single SC injection of placebo on Day 1. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG002 | DM-101 Low Multiple Ascending Doses (MAD) | 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. | 0 | 6 | 1 | 6 | 6 | 6 |
| EG003 | Placebo Low MAD | Participants received 5 biweekly administered SC injections of placebo on Day 1,14, 28, 42, and 56. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG004 | DM-101 High MAD | 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. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG005 | Placebo High MAD | 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. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG006 | DM-101 2-Day Ultra-Rush Dose Escalation | 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. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG007 | Placebo 2-Day Ultra-Rush Dose Escalation | Participants received 9 SC injections of placebo during Day 1 and Day 2. | 0 | 1 | 0 | 1 | 1 | 1 |
| Ear Pain | Ear and labyrinth disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Conjuctival Hyperaemia | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Eye Pruritus | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Nictitating Spasm | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Hypoaesthesia Oral | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Intestinal Ulcer | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Injection Site Erythema | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Injection Site Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Swelling Face | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Catheter Site Pruritus | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Injection Site Swelling | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Injection Site Pruritus | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Catheter Site Pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
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| Vaccination Complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
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| Forced Respiratory Volume Decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Blood Creatine Phosphokinase Increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Amnesia | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Hyperreflexia | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Orypharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Urticaria Papular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Papule | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Skin Reaction | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Herpes Zoster | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Eye Infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
|
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| Grade 2 |
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| Grade 3 |
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| Grade 4 |
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| Grade 5 |
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| Grade 2 |
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| Grade 3 |
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| Grade 4 |
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