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The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind, placebo-controlled setting
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
| |
| 3 | Experimental |
| |
| 4 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) | Drug | subcutaneous injections at 6 visits |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival Provocation Test (CPT) With House Dust Mite Allergen Solutions. Change of Median Individual Allergen Tolerance Compared to Baseline (Factor of Increase in Allergen Concentration to Induce a Threshold CPT Score ≥ 2) | The outcome measure is a conjunctival provocation test (CPT) with house dust mite allergen solutions. CPT score was measured as a sum of the following assessed symptoms: conjunctival hyperemia, tearing, itching, burning and swelling of eyelids. Each of the assessed symptom could be absent (0), mild (1 point), moderate (2 points) or severe (3 points). The provocation tests started with the maximal dilution of the allergen 1:1000. If the sum of the reached CPT score was <10 points, the test continued with the next dilution step 1:100. This procedure was repeated until patients reached the CPT score ≥ 10 points or the provocation solution reached the maximal concentration 1:1 (undiluted). The outcome is then given as the change of median individual allergen tolerance at month two compared to baseline. The change is expressed as a factor of increase in allergen concentration to induce a threshold CPT score ≥ 2. | baseline versus 2 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of the Study Treatment by Collection of Adverse Events | about 30 min. at each visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philipp Mueller, MD | Cytos Biotechnology | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | AllQbG10 | CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits |
| FG001 | Allergen | House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| House dust mite allergen extract in combination with CYT003-QbG10-placebo | Drug | subcutaneous injections at 6 visits |
|
| CYT003-AllQbG10 in combination with house dust mite allergen extract placebo | Drug | subcutaneous injections at 6 visits |
|
| CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo | Drug | subcutaneous injections at 6 visits |
|
| FG002 | QbG10 | CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits |
| FG003 | Placebo | CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AllQbG10 | CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits |
| BG001 | Allergen | House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits |
| BG002 | QbG10 | CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits |
| BG003 | Placebo | CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Conjunctival Provocation Test (CPT) With House Dust Mite Allergen Solutions. Change of Median Individual Allergen Tolerance Compared to Baseline (Factor of Increase in Allergen Concentration to Induce a Threshold CPT Score ≥ 2) | The outcome measure is a conjunctival provocation test (CPT) with house dust mite allergen solutions. CPT score was measured as a sum of the following assessed symptoms: conjunctival hyperemia, tearing, itching, burning and swelling of eyelids. Each of the assessed symptom could be absent (0), mild (1 point), moderate (2 points) or severe (3 points). The provocation tests started with the maximal dilution of the allergen 1:1000. If the sum of the reached CPT score was <10 points, the test continued with the next dilution step 1:100. This procedure was repeated until patients reached the CPT score ≥ 10 points or the provocation solution reached the maximal concentration 1:1 (undiluted). The outcome is then given as the change of median individual allergen tolerance at month two compared to baseline. The change is expressed as a factor of increase in allergen concentration to induce a threshold CPT score ≥ 2. | Posted | Median | Inter-Quartile Range | Factor of Increased Allergen Tolerance | baseline versus 2 months after baseline |
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| Secondary | Safety and Tolerability of the Study Treatment by Collection of Adverse Events | Not Posted | about 30 min. at each visit |
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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 | AllQbG10 | CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits | 1 | 10 | 8 | 10 | ||
| EG001 | Allergen | House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits | 0 | 10 | 10 | 10 | ||
| EG002 | QbG10 | CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits | 0 | 10 | 8 | 10 | ||
| EG003 | Placebo | CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits | 0 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fracture of right malleolus (accident) | Injury, poisoning and procedural complications |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations |
| |||
| Influenza | Infections and infestations |
| |||
| Asthma | Respiratory, thoracic and mediastinal disorders |
| |||
| Conjunctivitis allergic | Eye disorders |
| |||
| Local reactions | General disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Rhinitis | Infections and infestations |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Develpment | Cytos Biotechnology AG | +41 44 733 4 | 7 47 | info@cytos.com |
| ID | Term |
|---|---|
| D000092542 | Dust Mite Allergy |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C559986 | CYT003-QbG10 |
| D039741 | Antigens, Dermatophagoides |
| ID | Term |
|---|---|
| D000941 | Antigens |
| D001685 | Biological Factors |
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|