search
Back to results

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

Primary Purpose

Allergic Rhinitis, Rhinoconjunctivitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
placebo
AllerT low dose
AllerT full dose
Sponsored by
Anergis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring allergic rhinitis, birch pollen, immunotherapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Allergiklinikken
  • Lungemedicinsk Forskningsafdeling
  • Klinisk Institute
  • CHU de Reims
  • Hopitaux Universitaires de Strasbourg
  • Viktorija Vevere private practice of Allergology
  • Paul Stradins Clinical University Hospital - Pulmonology Allergology
  • Center of examination and treatment of allergic diseases
  • Kaunas Clinics University Hospital
  • Allergy Clinic JSC Perspektyvos
  • Vilnius University Hospital
  • Antakalnio affiliation of the Vilnius City Allergy Center
  • SPZOZ Uniwersytecki Szpital Kliniczny - Allergology
  • Alergologii Centrum
  • Alergotest
  • Alergo-Med
  • Centrum Alergologii IRMED
  • Silesian Piasts University of Medicine in Wrocław
  • Aler-med
  • NZOZ Przychodnia Lekarska Hipokrates
  • University hospital Skane
  • Orebro University Hospital
  • Lungavdelningen, Vastmanlands
  • Centre Hospitalier Universitaire Vaudois

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

placebo

AllerT low dose

AllerT full dose

Arm Description

SC injections of placebo

SC injections of AllerT 25 or 50 micrograms

SC injections of AllerT 50-100 micrograms

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of Life
mini-RQLQ questionnaires
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

Full Information

First Posted
October 29, 2012
Last Updated
March 30, 2015
Sponsor
Anergis
search

1. Study Identification

Unique Protocol Identification Number
NCT01720251
Brief Title
Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anergis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Rhinoconjunctivitis
Keywords
allergic rhinitis, birch pollen, immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
SC injections of placebo
Arm Title
AllerT low dose
Arm Type
Experimental
Arm Description
SC injections of AllerT 25 or 50 micrograms
Arm Title
AllerT full dose
Arm Type
Experimental
Arm Description
SC injections of AllerT 50-100 micrograms
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
SC injections of placebo on days 1, 7, 14, 28 and 56
Intervention Type
Drug
Intervention Name(s)
AllerT low dose
Other Intervention Name(s)
AllerT 25-50 micrograms
Intervention Description
SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56
Intervention Type
Drug
Intervention Name(s)
AllerT full dose
Other Intervention Name(s)
AllerT 50-100 micrograms
Intervention Description
SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56
Primary Outcome Measure Information:
Title
Combined Rhinoconjunctivitis Symptom and Medication Score
Description
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
Time Frame
up to 6 weeks during the birch pollen season 2013
Secondary Outcome Measure Information:
Title
Quality of Life
Description
mini-RQLQ questionnaires
Time Frame
up to 6 weeks during the birch pollen season 2013
Title
Safety and Tolerability
Description
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
Time Frame
from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks
Other Pre-specified Outcome Measures:
Title
Immunological Markers: Specific IgE and IgG4
Description
blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Spertini, MD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergiklinikken
City
Hellerup
State/Province
Copenhagen
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Lungemedicinsk Forskningsafdeling
City
Arhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Klinisk Institute
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
CHU de Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Hopitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Viktorija Vevere private practice of Allergology
City
Rezekne
ZIP/Postal Code
4601
Country
Latvia
Facility Name
Paul Stradins Clinical University Hospital - Pulmonology Allergology
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Center of examination and treatment of allergic diseases
City
Riga
ZIP/Postal Code
1003
Country
Latvia
Facility Name
Kaunas Clinics University Hospital
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Allergy Clinic JSC Perspektyvos
City
Vilnius
ZIP/Postal Code
08431
Country
Lithuania
Facility Name
Vilnius University Hospital
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Antakalnio affiliation of the Vilnius City Allergy Center
City
Vilnius
ZIP/Postal Code
10200
Country
Lithuania
Facility Name
SPZOZ Uniwersytecki Szpital Kliniczny - Allergology
City
Lodz
ZIP/Postal Code
90153
Country
Poland
Facility Name
Alergologii Centrum
City
Lodz
ZIP/Postal Code
90553
Country
Poland
Facility Name
Alergotest
City
Lublin
ZIP/Postal Code
20095
Country
Poland
Facility Name
Alergo-Med
City
Tarnow
ZIP/Postal Code
33100
Country
Poland
Facility Name
Centrum Alergologii IRMED
City
Warszawa
ZIP/Postal Code
01157
Country
Poland
Facility Name
Silesian Piasts University of Medicine in Wrocław
City
Wroclaw
ZIP/Postal Code
50-368
Country
Poland
Facility Name
Aler-med
City
Wroclaw
ZIP/Postal Code
54203
Country
Poland
Facility Name
NZOZ Przychodnia Lekarska Hipokrates
City
Zabrze
ZIP/Postal Code
41800
Country
Poland
Facility Name
University hospital Skane
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Orebro University Hospital
City
Orebro
ZIP/Postal Code
70185
Country
Sweden
Facility Name
Lungavdelningen, Vastmanlands
City
Vasteras
ZIP/Postal Code
72189
Country
Sweden
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
State/Province
VD
ZIP/Postal Code
1005
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs