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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anergis
ClinicalTrials.gov Identifier:
NCT01720251
First received: October 29, 2012
Last updated: March 30, 2015
Last verified: March 2015
Results First Received: March 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Allergic Rhinitis
Rhinoconjunctivitis
Interventions: Drug: placebo
Drug: AllerT low dose
Drug: AllerT full dose

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo

SC injections of placebo

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

AllerT Low Dose

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

AllerT Full Dose

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


Participant Flow:   Overall Study
    Placebo     AllerT Low Dose     AllerT Full Dose  
STARTED     79     79     82  
COMPLETED     78     77     82  
NOT COMPLETED     1     2     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
In AllerT low dose group, one patient has been randomized but not treated explaining the difference beween baseline participants number and participant flow

Reporting Groups
  Description
Placebo

SC injections of placebo

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

AllerT Low Dose

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

AllerT Full Dose

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 Total of all reporting groups

Baseline Measures
    Placebo     AllerT Low Dose     AllerT Full Dose     Total  
Number of Participants  
[units: participants]
  79     78     82     239  
Age  
[units: years]
Mean (Standard Deviation)
  34.1  (9.08)     36.2  (9.92)     36.4  (9.36)     35.6  (9.45)  
Gender  
[units: participants]
       
Female     38     43     43     124  
Male     41     35     39     115  



  Outcome Measures

1.  Primary:   Combined Rhinoconjunctivitis Symptom and Medication Score   [ Time Frame: up to 6 weeks during the birch pollen season 2013 ]

2.  Secondary:   Quality of Life   [ Time Frame: up to 6 weeks during the birch pollen season 2013 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Safety and Tolerability   [ Time Frame: from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Other Pre-specified:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr Gilles DELLA CORTE Clinical Development Director
Organization: ANERGIS SA
phone: +41 21 651 92 30
e-mail: gilles.dellacorte@anergis.ch



Responsible Party: Anergis
ClinicalTrials.gov Identifier: NCT01720251     History of Changes
Other Study ID Numbers: AN004T
2011-002259-32 ( EudraCT Number )
Study First Received: October 29, 2012
Results First Received: March 20, 2015
Last Updated: March 30, 2015
Health Authority: Denmark: Danish Health and Medicines Authority
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Lithuania: State Medicine Control Agency - Ministry of Health
Latvia: State Agency of Medicines
Poland: Ministry of Health
Sweden: Medical Products Agency
Switzerland: Swissmedic