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

NCT01720251 | Completed Phase 2 Results

• 2 other identifiers: AN004T2011-002259-32
• Study Type: interventional
• Target: 240
• Locations: 7 countries
• Sites: 24

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

Conditions

Allergic Rhinitis; Rhinoconjunctivitis

Keywords

allergic rhinitis; birch pollen; immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Quality of Life

  up to 6 weeks during the birch pollen season 2013

• Safety and Tolerability

  from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks

Other Outcomes (1)

• 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

Study Arms (3)

placebo

PLACEBO COMPARATOR

SC injections of placebo

Drug: placebo

AllerT low dose

EXPERIMENTAL

SC injections of AllerT 25 or 50 micrograms

Drug: AllerT low dose

AllerT full dose

EXPERIMENTAL

SC injections of AllerT 50-100 micrograms

Drug: AllerT full dose

Interventions

placebo DRUG

SC injections of placebo on days 1, 7, 14, 28 and 56

placebo

AllerT low dose DRUG

SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56

Also known as: AllerT 25-50 micrograms

AllerT low dose

AllerT full dose DRUG

SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56

Also known as: AllerT 50-100 micrograms

AllerT full dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anergis: lead

Study Sites (24)

Allergiklinikken

Hellerup, Copenhagen, 2900, Denmark

Location

Lungemedicinsk Forskningsafdeling

Aarhus, 8000, Denmark

Location

Klinisk Institute

Odense, 5000, Denmark

Location

CHU de Reims

Reims, 51092, France

Location

Hopitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location

Viktorija Vevere private practice of Allergology

Rēzekne, 4601, Latvia

Location

Paul Stradins Clinical University Hospital - Pulmonology Allergology

Riga, 1002, Latvia

Location

Center of examination and treatment of allergic diseases

Riga, 1003, Latvia

Location

Kaunas Clinics University Hospital

Kaunas, 50009, Lithuania

Location

Allergy Clinic JSC Perspektyvos

Vilnius, 08431, Lithuania

Location

Vilnius University Hospital

Vilnius, 08661, Lithuania

Location

Antakalnio affiliation of the Vilnius City Allergy Center

Vilnius, 10200, Lithuania

Location

SPZOZ Uniwersytecki Szpital Kliniczny - Allergology

Lodz, 90153, Poland

Location

Alergologii Centrum

Lodz, 90553, Poland

Location

Alergotest

Lublin, 20095, Poland

Location

Alergo-Med

Tarnów, 33100, Poland

Location

Centrum Alergologii IRMED

Warsaw, 01157, Poland

Location

Silesian Piasts University of Medicine in Wrocław

Wroclaw, 50-368, Poland

Location

Aler-med

Wroclaw, 54203, Poland

Location

NZOZ Przychodnia Lekarska Hipokrates

Zabrze, 41800, Poland

Location

University hospital Skane

Lund, 22185, Sweden

Location

Orebro University Hospital

Örebro, 70185, Sweden

Location

Lungavdelningen, Vastmanlands

Västerås, 72189, Sweden

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1005, Switzerland

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr Gilles DELLA CORTE Clinical Development Director
• Organization: ANERGIS SA

gilles.dellacorte@anergis.ch

+41 21 651 92 30

Study Officials

• Francois Spertini, MD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: November 2, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 13, 2015
• Results First Posted: April 13, 2015

Record last verified: 2015-03

Locations

DK (3); FR (2); SE (3); CH (1); LA (3); PL (8); LI (4)