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

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ClinicalTrials.gov Identifier: NCT01292070
Recruitment Status : Terminated (Futility)
First Posted : February 9, 2011
Results First Posted : February 20, 2014
Last Update Posted : February 20, 2014
Sponsor:
Collaborators:
Immune Tolerance Network (ITN)
Tunitas Therapeutics, Inc.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (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
Enrollment 4
Recruitment Details 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  
Arm/Group Title Control (CAT) - Experimental (GFD)
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Control (CAT) - Experimental (GFD)
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
Intent-to-treat
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
25.3  (2.4)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
2
  50.0%
Male
2
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 4 participants
4
1.Primary Outcome
Title 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
Hide Description Difference in the doses of human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD) and standardized cat hair allergenic extract (CAT) required to elicit a wheal ≥ 10 mm with surrounding erythema.
Time Frame up to 3 hours after the last injection of GFD
Hide Outcome Measure Data
Hide Analysis Population Description
The experimental protein (human Fcgamma1-Fel d1 fusion protein (GFD)) and the control protein (standardized cat hair allergenic extract (CAT)) elicited comparable reactivity in the first four participants dosed; thus, the trial was discontinued for futility and the primary endpoint was not evaluated
Arm/Group Title Control (CAT) - Experimental (GFD)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Start of study through Day 28
Adverse Event Reporting Description Adverse events severities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (published May 28, 2009 and updated to 4.02 on September 15, 2009). Wheal, erythema, and pruritus at site of administration were expected outcomes and thus were not reported as adverse events
 
Arm/Group Title Control (CAT) - Experimental (GFD)
Hide Arm/Group Description 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).
All-Cause Mortality
Control (CAT) - Experimental (GFD)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control (CAT) - Experimental (GFD)
Affected / at Risk (%) # Events
Total   0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control (CAT) - Experimental (GFD)
Affected / at Risk (%) # Events
Total   1/4 (25.00%)    
Infections and infestations   
Rhinitis   1/4 (25.00%)  1
Indicates events were collected by systematic assessment
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
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nolan Sigal, MD, PhD, CEO, Tunitas Therapeutics
Organization: Tunitas Therapeutics
Phone: (650) 887-4747
EMail: nsigal@tunitastherapeutics.com
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01292070     History of Changes
Other Study ID Numbers: DAIT ITN048AD
First Submitted: February 7, 2011
First Posted: February 9, 2011
Results First Submitted: January 6, 2014
Results First Posted: February 20, 2014
Last Update Posted: February 20, 2014