Safety Evaluation of an Experimental Treatment, Intradermal Human Fcγ1-Fel d1 Fusion Protein (GFD), for Cat Allergy

This study has been terminated.
(Futility)
Sponsor:
Collaborators:
Immune Tolerance Network (ITN)
Tunitas Therapeutics
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01292070
First received: February 7, 2011
Last updated: January 6, 2014
Last verified: January 2014
Results First Received: January 6, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cat Allergy
Interventions: Biological: Intradermal Human Fcγ1-Fel d1 fusion protein
Biological: Positive Control - standardized cat hair allergenic extract (CAT)
Biological: Positive Control - Histamine Prick
Biological: Negative Control - Intradermal Diluent

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
One center in Australia recruited four participants with a history of allergic reactivity to cats as expressed by allergic rhinitis and who had reactivity to standardized cat hair allergenic extract

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
Control (CAT) - Experimental (GFD) Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).

Participant Flow:   Overall Study
    Control (CAT) - Experimental (GFD)  
STARTED     4  
COMPLETED     4  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Intent-to-treat

Reporting Groups
  Description
Control (CAT) - Experimental (GFD) Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).

Baseline Measures
    Control (CAT) - Experimental (GFD)  
Number of Participants  
[units: participants]
  4  
Age  
[units: years]
Mean ± Standard Deviation
  25.3  ± 2.4  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     0  
Gender  
[units: participants]
 
Female     2  
Male     2  
Region of Enrollment  
[units: participants]
 
Australia     4  



  Outcome Measures

1.  Primary:   Difference in the Doses of GFD and CAT Required to Elicit a Cutaneous Reaction Demonstrated by a Wheal Greater Than or Equal to 10 mm With Surrounding Erythema   [ Time Frame: up to 3 hours after the last injection of GFD ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Limitations and Caveats
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
The experimental protein (human Fcgamma1-Fel d1 fusion protein) & control protein (standardized cat hair allergenic extract) elicited comparable reactivity in the first four participants dosed and consequently the trial was discontinued for futility  


Results Point of Contact:  
Name/Title: Nolan Sigal, MD, PhD, CEO, Tunitas Therapeutics
Organization: Tunitas Therapeutics
phone: (650) 887-4747
e-mail: nsigal@tunitastherapeutics.com


No publications provided


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01292070     History of Changes
Other Study ID Numbers: DAIT ITN048AD
Study First Received: February 7, 2011
Results First Received: January 6, 2014
Last Updated: January 6, 2014
Health Authority: United States: Federal Government
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee