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

Allergic Rhinitis Clinical Trial

Official title:

Phase IIb Study to Assess the Efficacy, Safety and Tolerability of Two Dosing Regimens of AllerT in Comparison to Placebo in Adult Subjects Allergic to Birch Pollen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720251
• Other study ID #: AN004T
• Secondary ID: 2011-002259-32
• Status: Completed
• Phase: Phase 2
• First received: October 29, 2012
• Last updated: March 30, 2015
• Start date: October 2012
• Est. completion date: September 2013

Study information

• Verified date: March 2015
• Source: Anergis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityFrance: Agence Nationale de Sécurité du Médicament et des produits de santéLithuania: State Medicine Control Agency - Ministry of HealthLatvia: State Agency of MedicinesPoland: Ministry of HealthSweden: Medical Products AgencySwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinoconjunctivitis

Intervention

Drug:
• placebo
SC injections of placebo on days 1, 7, 14, 28 and 56
• AllerT low dose
SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56
• AllerT full dose
SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56

Locations

Country	Name	City	State
Denmark	Lungemedicinsk Forskningsafdeling	Arhus
Denmark	Allergiklinikken	Hellerup	Copenhagen
Denmark	Klinisk Institute	Odense
France	CHU de Reims	Reims
France	Hopitaux Universitaires de Strasbourg	Strasbourg
Latvia	Viktorija Vevere private practice of Allergology	Rezekne
Latvia	Center of examination and treatment of allergic diseases	Riga
Latvia	Paul Stradins Clinical University Hospital - Pulmonology Allergology	Riga
Lithuania	Kaunas Clinics University Hospital	Kaunas
Lithuania	Allergy Clinic JSC Perspektyvos	Vilnius
Lithuania	Antakalnio affiliation of the Vilnius City Allergy Center	Vilnius
Lithuania	Vilnius University Hospital	Vilnius
Poland	Alergologii Centrum	Lodz
Poland	SPZOZ Uniwersytecki Szpital Kliniczny - Allergology	Lodz
Poland	Alergotest	Lublin
Poland	Alergo-Med	Tarnow
Poland	Centrum Alergologii IRMED	Warszawa
Poland	Aler-med	Wroclaw
Poland	Silesian Piasts University of Medicine in Wroclaw	Wroclaw
Poland	NZOZ Przychodnia Lekarska Hipokrates	Zabrze
Sweden	University hospital Skane	Lund
Sweden	Orebro University Hospital	Orebro
Sweden	Lungavdelningen, Vastmanlands	Vasteras
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	VD

Sponsors (1)

Lead Sponsor	Collaborator
Anergis

Countries where clinical trial is conducted

Denmark,  France,  Latvia,  Lithuania,  Poland,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immunological Markers: Specific IgE and IgG4	blood samples will be drawn at the above time points to measure 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	No
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	up to 6 weeks during the birch pollen season 2013	No
Secondary	Quality of Life	mini-RQLQ questionnaires	up to 6 weeks during the birch pollen season 2013	No
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	from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks	No