Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy

Anergis

Status and phase: Completed; Phase 2

Conditions: Rhinoconjunctivitis; Allergic Rhinitis

Treatments: Drug: AllerT low dose; Drug: AllerT full dose; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01720251

AN004T

2011-002259-32 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 240 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

SC injections of placebo

Treatment:

Drug: placebo

AllerT low dose

Experimental group

Description:

SC injections of AllerT 25 or 50 micrograms

Treatment:

Drug: AllerT low dose

AllerT full dose

Experimental group

Description:

SC injections of AllerT 50-100 micrograms

Treatment:

Drug: AllerT full dose