ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01720251
Recruitment Status : Completed
First Posted : November 2, 2012
Results First Posted : April 13, 2015
Last Update Posted : April 13, 2015
Sponsor:
Information provided by (Responsible Party):
Anergis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Allergic Rhinitis
Rhinoconjunctivitis
Interventions Drug: placebo
Drug: AllerT low dose
Drug: AllerT full dose
Enrollment 240

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo AllerT Low Dose AllerT Full Dose
Hide Arm/Group Description

SC injections of placebo

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

SC injections of AllerT 25 or 50 micrograms

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

SC injections of AllerT 50-100 micrograms

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

Period Title: Overall Study
Started 79 79 82
Completed 78 77 82
Not Completed 1 2 0
Arm/Group Title Placebo AllerT Low Dose AllerT Full Dose Total
Hide Arm/Group Description

SC injections of placebo

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

SC injections of AllerT 25 or 50 micrograms

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

SC injections of AllerT 50-100 micrograms

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

Total of all reporting groups
Overall Number of Baseline Participants 79 78 82 239
Hide Baseline Analysis Population Description
In AllerT low dose group, one patient has been randomized but not treated explaining the difference beween baseline participants number and participant flow
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants 78 participants 82 participants 239 participants
34.1  (9.08) 36.2  (9.92) 36.4  (9.36) 35.6  (9.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 78 participants 82 participants 239 participants
Female
38
  48.1%
43
  55.1%
43
  52.4%
124
  51.9%
Male
41
  51.9%
35
  44.9%
39
  47.6%
115
  48.1%
1.Primary Outcome
Title Combined Rhinoconjunctivitis Symptom and Medication Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo AllerT Low Dose AllerT Full Dose
Hide Arm/Group Description:

SC injections of placebo

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

SC injections of AllerT 25 or 50 micrograms

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

SC injections of AllerT 50-100 micrograms

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

Overall Number of Participants Analyzed 78 77 82
Mean (Standard Deviation)
Unit of Measure: score (maximum=3)
0.86  (0.603) 0.64  (0.530) 0.72  (0.573)
2.Secondary Outcome
Title Quality of Life
Hide Description mini-RQLQ questionnaires
Time Frame up to 6 weeks during the birch pollen season 2013
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Safety and Tolerability
Hide 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
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Immunological Markers: Specific IgE and IgG4
Hide 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
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Allert 50 µg AllerT 100 µg
Hide Arm/Group Description All patients having received at least one injection of Placebo (Safety Set) All patients having received at least one injection of Allert 50 µg (Safety Set) All patients having received at least one injection of Allert 100 µg (Safety Set)
All-Cause Mortality
Placebo Allert 50 µg AllerT 100 µg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Allert 50 µg AllerT 100 µg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/79 (0.00%)      1/78 (1.28%)      2/82 (2.44%)    
Eye disorders       
conjunctivitis * 1  0/79 (0.00%)  0 1/78 (1.28%)  1 0/82 (0.00%)  0
Gastrointestinal disorders       
Oropharyngeal discomfort * 3  0/79 (0.00%)  0 1/78 (1.28%)  1 0/82 (0.00%)  0
Tongue oedema * 5  0/79 (0.00%)  0 1/78 (1.28%)  1 0/82 (0.00%)  0
General disorders       
Hypersensitivity * 2  0/79 (0.00%)  0 0/78 (0.00%)  0 1/82 (1.22%)  1
Musculoskeletal and connective tissue disorders       
Skull fracture * 4 [1]  0/79 (0.00%)  0 0/78 (0.00%)  0 1/82 (1.22%)  1
Skin and subcutaneous tissue disorders       
Urticaria * 6  0/79 (0.00%)  0 1/78 (1.28%)  1 0/82 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, conjunctivitis
2
Term from vocabulary, Hypersensitivity
3
Term from vocabulary, Oropharyngeal discom
4
Term from vocabulary, Skull fracture
5
Term from vocabulary, Tongue oedema
6
Term from vocabulary, Urticaria
[1]
considered as non drug-related
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Allert 50 µg AllerT 100 µg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   59/79 (74.68%)      70/78 (89.74%)      70/82 (85.37%)    
Eye disorders       
Conjunctivitis  9  5/79 (6.33%)  11/78 (14.10%)  12/82 (14.63%) 
Respiratory, thoracic and mediastinal disorders       
Nasopharyngitis  3  14/79 (17.72%)  13/78 (16.67%)  16/82 (19.51%) 
Rhinitis  5  7/79 (8.86%)  22/78 (28.21%)  25/82 (30.49%) 
Dyspnea  6  5/79 (6.33%)  17/78 (21.79%)  25/82 (30.49%) 
Cough  7  2/79 (2.53%)  12/78 (15.38%)  26/82 (31.71%) 
Skin and subcutaneous tissue disorders       
Injection site pain  1  26/79 (32.91%)  20/78 (25.64%)  16/82 (19.51%) 
Injection site reaction  2  10/79 (12.66%)  19/78 (24.36%)  15/82 (18.29%) 
Injection site erythema  4  18/79 (22.78%)  7/78 (8.97%)  11/82 (13.41%) 
Pruritus  8  3/79 (3.80%)  20/78 (25.64%)  11/82 (13.41%) 
Injection site oedema  10  9/79 (11.39%)  8/78 (10.26%)  13/82 (15.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, Injection site pain
2
Term from vocabulary, Injection site react
3
Term from vocabulary, Nasopharyngitis
4
Term from vocabulary, Injection site eryth
5
Term from vocabulary, Rhinitis
6
Term from vocabulary, Dyspnea
7
Term from vocabulary, Cough
8
Term from vocabulary, Pruritus
9
Term from vocabulary, Conjunctivitis
10
Term from vocabulary, Injection site oedem
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PI of the trial owns options in the sponsor company and is member of the Board of Anergis SA
Results Point of Contact
Name/Title: Dr Gilles DELLA CORTE Clinical Development Director
Organization: ANERGIS SA
Phone: +41 21 651 92 30
Responsible Party: Anergis
ClinicalTrials.gov Identifier: NCT01720251     History of Changes
Other Study ID Numbers: AN004T
2011-002259-32 ( EudraCT Number )
First Submitted: October 29, 2012
First Posted: November 2, 2012
Results First Submitted: March 20, 2015
Results First Posted: April 13, 2015
Last Update Posted: April 13, 2015