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

Phase 2

Completed

• Conditions: Rhinoconjunctivitis; Allergic Rhinitis
• Interventions: Drug: AllerT full dose; Drug: placebo; Drug: AllerT low dose

• Registration Number: NCT01720251
• Lead Sponsor: Anergis

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-10-31
• Study First Posted: 2012-11-02
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2015-03
• Results First Submitted: 2015-03-20
• Results First Submitted QC: 2015-03-30
• Last Update Submitted: 2015-03-30
• Results First Posted: 2015-04-13
• Last Update Posted: 2015-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AllerT full dose	AllerT full dose	SC injections of AllerT 50-100 micrograms
placebo	placebo	SC injections of placebo
AllerT low dose	AllerT low dose	SC injections of AllerT 25 or 50 micrograms

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (24)

Viktorija Vevere private practice of Allergology; 🇱🇻 Rezekne, Latvia

Alergotest; 🇵🇱 Lublin, Poland

Centrum Alergologii IRMED; 🇵🇱 Warszawa, Poland

Silesian Piasts University of Medicine in Wrocław; 🇵🇱 Wroclaw, Poland

Orebro University Hospital; 🇸🇪 Orebro, Sweden

Lungavdelningen, Vastmanlands; 🇸🇪 Vasteras, Sweden

Lungemedicinsk Forskningsafdeling; 🇩🇰 Arhus, Denmark

Allergiklinikken; 🇩🇰 Hellerup, Copenhagen, Denmark

Klinisk Institute; 🇩🇰 Odense, Denmark

University hospital Skane; 🇸🇪 Lund, Sweden

CHU de Reims; 🇫🇷 Reims, France

Paul Stradins Clinical University Hospital - Pulmonology Allergology; 🇱🇻 Riga, Latvia

Allergy Clinic JSC Perspektyvos; 🇱🇹 Vilnius, Lithuania

SPZOZ Uniwersytecki Szpital Kliniczny - Allergology; 🇵🇱 Lodz, Poland

Alergologii Centrum; 🇵🇱 Lodz, Poland

Alergo-Med; 🇵🇱 Tarnow, Poland

NZOZ Przychodnia Lekarska Hipokrates; 🇵🇱 Zabrze, Poland

Center of examination and treatment of allergic diseases; 🇱🇻 Riga, Latvia

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, VD, Switzerland

Aler-med; 🇵🇱 Wroclaw, Poland

Hopitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

Kaunas Clinics University Hospital; 🇱🇹 Kaunas, Lithuania

Vilnius University Hospital; 🇱🇹 Vilnius, Lithuania

Antakalnio affiliation of the Vilnius City Allergy Center; 🇱🇹 Vilnius, Lithuania