Allergic Rhinitis, Rhinoconjunctivitis
Conditions
Keywords
allergic rhinitis, birch pollen, immunotherapy
Brief summary
The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season
Interventions
DRUGplacebo
SC injections of placebo on days 1, 7, 14, 28 and 56
DRUGAllerT low dose
SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56
DRUGAllerT full dose
SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56
Sponsors
Anergis
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 55 Years
Healthy volunteers
No
Inclusion criteria
* moderate to severe allergic rhinoconjunctivitis to birch pollen: 1. Score of symptoms of the Rhinoconjunctivitis Symptom Score (RSS) ≥ 12 during the two preceding birch pollen seasons 2. Previous use of anti-allergy medications during the two preceding birch pollen seasons 3. Positive SPT to birch pollen extract 4. Positive specific IgE CAP test for Bet v 1
Exclusion criteria
* uncontrolled asthma, FEV1 \< 80% of predicted * previous SIT (specific immunotherapy) to birch pollen or any other SIT within 5 years * clinical symptoms due to allergens other than birch pollen during the whole trial period * history of anaphylaxis * positive skin prick test to AllerT * any other treatment or conditions which may increase the risk of the study for the subject or affect the efficacy assessments during the birch pollen season
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined Rhinoconjunctivitis Symptom and Medication Score | up to 6 weeks during the birch pollen season 2013 | The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first. The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | up to 6 weeks during the birch pollen season 2013 | mini-RQLQ questionnaires |
| Safety and Tolerability | from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks | Adverse events will be collected throughout the trial period and will be reported as Treatment emergent adverse events occurring between start of treatment and 28 days after completion of treatment for each subject |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immunological Markers: Specific IgE and IgG4 | before treatment, 4 weeks after the last injection and 2 weeks before, at the peak time and within 2 weeks after the end of the expected birch pollen season 2013 | blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4 |
Countries
Denmark, France, Latvia, Lithuania, Poland, Sweden, Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo SC injections of placebo
placebo: SC injections of placebo on days 1, 7, 14, 28 and 56 | 79 |
| AllerT Low Dose SC injections of AllerT 25 or 50 micrograms
AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56 | 78 |
| AllerT Full Dose SC injections of AllerT 50-100 micrograms
AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56 | 82 |
| Total | 239 |
Baseline characteristics
| Characteristic | Placebo | AllerT Low Dose | AllerT Full Dose | Total |
|---|---|---|---|---|
| Age, Continuous | 34.1 years STANDARD_DEVIATION 9.08 | 36.2 years STANDARD_DEVIATION 9.92 | 36.4 years STANDARD_DEVIATION 9.36 | 35.6 years STANDARD_DEVIATION 9.45 |
| Sex: Female, Male Female | 38 Participants | 43 Participants | 43 Participants | 124 Participants |
| Sex: Female, Male Male | 41 Participants | 35 Participants | 39 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 59 / 79 | 70 / 78 | 70 / 82 |
| serious Total, serious adverse events | 0 / 79 | 1 / 78 | 2 / 82 |
Outcome results
Primary
Combined Rhinoconjunctivitis Symptom and Medication Score
The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first. The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2
Time frame: up to 6 weeks during the birch pollen season 2013
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Combined Rhinoconjunctivitis Symptom and Medication Score | 0.86 score (maximum=3) | Standard Deviation 0.603 |
| AllerT Low Dose | Combined Rhinoconjunctivitis Symptom and Medication Score | 0.64 score (maximum=3) | Standard Deviation 0.53 |
| AllerT Full Dose | Combined Rhinoconjunctivitis Symptom and Medication Score | 0.72 score (maximum=3) | Standard Deviation 0.573 |
Secondary
Quality of Life
mini-RQLQ questionnaires
Time frame: up to 6 weeks during the birch pollen season 2013
Secondary
Safety and Tolerability
Adverse events will be collected throughout the trial period and will be reported as Treatment emergent adverse events occurring between start of treatment and 28 days after completion of treatment for each subject
Time frame: from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks
Other Pre-specified
Immunological Markers: Specific IgE and IgG4
blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4
Time frame: before treatment, 4 weeks after the last injection and 2 weeks before, at the peak time and within 2 weeks after the end of the expected birch pollen season 2013