Phase 2
N=240
Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy
Allergic Rhinitis · Rhinoconjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT01720251 ↗Enrolled (actual)
240
Serious AEs
1.3%
Results posted
Apr 2015
Primary outcome: Primary: Combined Rhinoconjunctivitis Symptom and Medication Score — 0.86; 0.64; 0.72 score (maximum=3)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- placebo (Drug); AllerT low dose (Drug); AllerT full dose (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Anergis
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Combined Rhinoconjunctivitis Symptom and Medication Score |
0.86; 0.64; 0.72 | — |
| SECONDARY Quality of Life |
— | — |
| SECONDARY Safety and Tolerability |
— | — |
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
Eligibility Criteria
Inclusion Criteria
- moderate to severe allergic rhinoconjunctivitis to birch pollen:
- Score of symptoms of the Rhinoconjunctivitis Symptom Score (RSS) ≥ 12 during the two preceding birch pollen seasons
- Previous use of anti-allergy medications during the two preceding birch pollen seasons
- Positive SPT to birch pollen extract
- 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
Data sourced from ClinicalTrials.gov (NCT01720251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.