A Phase 2 interventional study of placebo and AllerT low dose in Allergic Rhinitis and Rhinoconjunctivitis, sponsored by Anergis. Completed at 24 sites in 7 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-04-13.
Sponsored by Anergis · Phase 2, Interventional, and Treatment
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
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 240 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Anergis is the lead sponsor of 6 studies on the registry; none are open to participants now.
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moderate to severe allergic rhinoconjunctivitis to birch pollen:
Exclusion Criteria:
SC injections of placebo
Drug: placebo
SC injections of AllerT 25 or 50 micrograms
Drug: AllerT low dose
SC injections of AllerT 50-100 micrograms
Drug: AllerT full dose
SC injections of placebo on days 1, 7, 14, 28 and 56
SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56
Also known as: AllerT 25-50 micrograms
SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56
Also known as: AllerT 50-100 micrograms
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
Quality of Life
mini-RQLQ questionnaires
Time frame: up to 6 weeks during the birch pollen season 2013
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
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
| Milestone | Placebo | AllerT Low Dose | AllerT Full Dose |
|---|---|---|---|
| Started | 79 | 79 | 82 |
| Completed | 78 | 77 | 82 |
| Not completed | 1 | 2 | 0 |
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
| score (maximum=3) | Placebo | AllerT Low Dose | AllerT Full Dose |
|---|---|---|---|
| Combined Rhinoconjunctivitis Symptom and Medication Score | 0.86 ± 0.603 | 0.64 ± 0.530 | 0.72 ± 0.573 |
mini-RQLQ questionnaires
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/79 (0%) | 59/79 (74.7%) |
| Allert 50 µg | — | 1/78 (1.3%) | 70/78 (89.7%) |
| AllerT 100 µg | — | 2/82 (2.4%) | 70/82 (85.4%) |
| Event | Placebo | Allert 50 µg | AllerT 100 µg |
|---|---|---|---|
| conjunctivitisEye disorders | 0/79 | 1/78 | 0/82 |
| Oropharyngeal discomfortGastrointestinal disorders | 0/79 | 1/78 | 0/82 |
| Tongue oedemaGastrointestinal disorders | 0/79 | 1/78 | 0/82 |
| UrticariaSkin and subcutaneous tissue disorders | 0/79 | 1/78 | 0/82 |
| HypersensitivityGeneral disorders | 0/79 | 0/78 | 1/82 |
| Skull fractureMusculoskeletal and connective tissue disorders | 0/79 | 0/78 | 1/82 |
| Event | Placebo | Allert 50 µg | AllerT 100 µg |
|---|---|---|---|
| Injection site painSkin and subcutaneous tissue disorders | 26/79 | 20/78 | 16/82 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/79 | 12/78 | 26/82 |
| RhinitisRespiratory, thoracic and mediastinal disorders | 7/79 | 22/78 | 25/82 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 5/79 | 17/78 | 25/82 |
| PruritusSkin and subcutaneous tissue disorders | 3/79 | 20/78 | 11/82 |
| Injection site reactionSkin and subcutaneous tissue disorders | 10/79 | 19/78 | 15/82 |
| Injection site erythemaSkin and subcutaneous tissue disorders | 18/79 | 7/78 | 11/82 |
| NasopharyngitisRespiratory, thoracic and mediastinal disorders | 14/79 | 13/78 | 16/82 |
| Injection site oedemaSkin and subcutaneous tissue disorders | 9/79 | 8/78 | 13/82 |
| ConjunctivitisEye disorders | 5/79 | 11/78 | 12/82 |
In AllerT low dose group, one patient has been randomized but not treated explaining the difference beween baseline participants number and participant flow
| Age, Continuous(years) | Placebo | AllerT Low Dose | AllerT Full Dose | Total |
|---|---|---|---|---|
| Mean | 34.1 ± 9.08 | 36.2 ± 9.92 | 36.4 ± 9.36 | 35.6 ± 9.45 |
| Sex: Female, Male(Participants) | Placebo | AllerT Low Dose | AllerT Full Dose | Total |
|---|---|---|---|---|
| Female | 38 | 43 | 43 | 124 |
| Male | 41 | 35 | 39 | 115 |
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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