House Dust Mite Allergy, Perennial Allergic Rhinoconjunctivitis
Conditions
Brief summary
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
Interventions
subcutaneous injections at 6 visits
subcutaneous injections at 6 visits
DRUGCYT003-AllQbG10 in combination with house dust mite allergen extract placebo
subcutaneous injections at 6 visits
DRUGCYT003-QbG10-placebo in combination with house dust mite allergen extract placebo
subcutaneous injections at 6 visits
Sponsors
Cytos Biotechnology AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite allergens
Exclusion criteria
* Clinically relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments * Use of any concomitant medication that could affect the patient's study treatment response or assessment results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | baseline versus 2 months after baseline | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Tolerability of the Study Treatment by Collection of Adverse Events | about 30 min. at each visit |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AllQbG10 CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits | 10 |
| Allergen House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits | 10 |
| QbG10 CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits | 10 |
| Placebo CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits | 10 |
| Total | 40 |
Baseline characteristics
| Characteristic | Allergen | QbG10 | AllQbG10 | Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 40 Participants |
| Age Continuous | 36.5 years STANDARD_DEVIATION 9.8 | 36.8 years STANDARD_DEVIATION 11 | 34.2 years STANDARD_DEVIATION 8.6 | 31.0 years STANDARD_DEVIATION 15.9 | 34.6 years STANDARD_DEVIATION 11.5 |
| Region of Enrollment Europe | 10 participants | 10 participants | 10 participants | 10 participants | 40 participants |
| Sex: Female, Male Female | 6 Participants | 3 Participants | 3 Participants | 4 Participants | 16 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 7 Participants | 6 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 10 | 10 / 10 | 8 / 10 | 10 / 10 |
| serious Total, serious adverse events | 1 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: baseline versus 2 months after baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AllQbG10 | 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) | 10 Factor of Increased Allergen Tolerance |
| Allergen | 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) | 10 Factor of Increased Allergen Tolerance |
| QbG10 | 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) | 10 Factor of Increased Allergen Tolerance |
| Placebo | 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) | 1 Factor of Increased Allergen Tolerance |
Secondary
Safety and Tolerability of the Study Treatment by Collection of Adverse Events
Time frame: about 30 min. at each visit