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

Primary Purpose

Cat Allergy

Status

Terminated

Phase

Early Phase 1

Locations

Australia

Study Type

Interventional

Intervention

Intradermal Human Fcγ1-Fel d1 fusion protein

Positive Control - standardized cat hair allergenic extract (CAT)

Positive Control - Histamine Prick

Negative Control - Intradermal Diluent

About this trial

This is an interventional treatment trial for Cat Allergy focused on measuring Fel d 1 protein, Felis domesticus, Injections, Intradermal

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

History of allergic reactivity to cats as expressed by allergic rhinitis
Radioallergosorbent test (RAST test) for cat-specific IgE with RAST rating of 2 (0.70-3.49 KU/L IgE) documented within the past year or at screening
Standardized cat hair allergenic extract (CAT), 10,000 BAL/mL (ALK-Abello) elicits a wheal 5 mm or greater than the diluent control (Saline Albumin with Phenol [HSA], ALK-Abello) with surrounding erythema on testing using a standardized epicutaneous delivery device (Stallergenes Prick Lancet, 1 mm tip)
Histamine (Histatrol 1mg/mL, ALK-Abello) reactivity of 5 mm or greater reactivity than the diluent control with surrounding erythema on epicutaneous testing using a standardized epicutaneous delivery device
Able and willing to discontinue any anti-histamine use for 5 days prior to entry into protocol and throughout the protocol participation
Baseline spirometry (FEV1, FVC FEF25-75) with FEV1 >=80% predicted and other values within the normal range
Ability to give written informed consent

Exclusion Criteria:

Diluent control (Saline Albumin with Phenol [HSA], ALK-Abello) elicits wheal >= 3 mm on epicutaneous testing using a standardized epicutaneous delivery device
Pregnant females as determined by a positive serum or urine hCG test
Lactating females
Ever having received allergen immunotherapy (e.g., -subcutaneous allergen [SCIT] or -sublingual [SLIT])
Systemic steroids in the past 3 months
Severe systemic reactivity on exposure to cats (e.g., laryngeal or angioedema, fainting, pallor, bradycardia, hypotension, bronchospasm, asthma, or generalized urticaria)
A clinical history of asthma
Underlying heart, liver, kidney lung, or other medical condition (acute infections, immune diseases, current substance abuse) such that the person would be at a clearly increased risk for a poor outcome should a generalized allergic reaction occur
Use of systemic beta-blocking or ACE-inhibiting agents within the past 3 weeks
Use of tri-cyclic antidepressants within the past 3 weeks
Subjects receiving therapy with any agents known or likely to interact with adrenaline (e.g., beta blockers, ACE-Inhibitors, tri-cyclic antidepressants, or other)
Current use or use of omalizumab (Xolair) within past 6 months
Subjects with any extensive skin disorder (atopic dermatitis) that would make skin testing or proper interpretation impractical
Mental impairment, limiting the ability to comply with study requirements
Participation in a clinical trial and receipt of an investigational product within 30 days, 5 half-lives or twice the duration of the biochemical effect of the investigational product (whichever is longer) prior to dosing in the current study

Sites / Locations

Alfred Hospital and Monash University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Control-Experimental arm

Arm Description

Each subject will serve as their own control with the left arm receiving the control protein (Histamine prick, intradermal diluent and intradermal CAT) and right arm receiving the experimental protein (GFD).

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01292070

First Posted

February 7, 2011

Last Updated

January 6, 2014

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Immune Tolerance Network (ITN), Tunitas Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01292070

Brief Title

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

Official Title

A Dose-Escalating Phase 0 Study to Evaluate the Safety and Local Cutaneous Reactivity of Intradermal Human Fcγ1-Fel d1 Fusion Protein (GFD) in Cat-allergic Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Terminated

Why Stopped

Futility

Study Start Date

March 2011 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Immune Tolerance Network (ITN), Tunitas Therapeutics, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this trial is to show that Intradermal Human Fcγ1-Fel d1 fusion protein (GFD) is able to block the skin reaction to cat allergen in cat allergic subjects compared to the skin reaction to cat allergen alone. This research project is also testing the safety and tolerability of this new, experimental treatment, compared to the current treatment of cat allergen alone.

Detailed Description

Researchers are conducting a research study of a new protein developed to treat sensitivity to cat allergens. Cat allergy in humans is an allergic reaction to one or more of the five known allergens produced by cats. The most common of these is the protein Fel d 1. This study will test Intradermal Human Fcγ1-Fel d1 fusion protein (GFD), a new protein that, based on animal data, has been developed to block the allergic effects of cat. If this drug works the way they think it does, it may become a treatment for cat allergy that is faster than the currently available treatments and with fewer side effects. This protein contains the molecule from the cat, that causes the allergic reaction, attached to a section of a particular antibody (protein involved in immunity) called Fcγ1 that acts like a break. The fusion of the two proteins is predicted to interrupt the flow of cellular reactions which lead to the allergic response. This will be the first time GFD is administered to humans. The study will be conducted in two parts. The subjects in part A will be administered intradermal standardized cat hair allergenic extract (CAT) and GFD sequentially in 10-fold increasing doses every 20 minutes. If Part A demonstrates the safety of GFD,subject in part B will begin by following the same treatment as part A followed by a rechallenge of the sites with CAT at 4 hours after the first dose of GFD. Each subject will be evaluated 3 times (screening, dosing, and telephone follow-up 2 days post dosing) and will return on Day 28 for blood draw.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cat Allergy

Keywords

Fel d 1 protein, Felis domesticus, Injections, Intradermal

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control-Experimental arm

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Intradermal Human Fcγ1-Fel d1 fusion protein

Intervention Description

Part A: 7 sequential 10-fold dose increments from 0.001 BAU/mL to 1,000 BAU/mL; An 8th dose of 10,000 BAU/mL might be given only if the 10 BAU/mL of CAT is the dose that elicits a bump or hive of >= to 10mm. Part B: 5 sequential 10-fold dose increments from 0.1 BAU/mL to 1,000 BAU/mL; An 6th dose of 10,000 BAU/mL might be given only if the 10 BAU/mL of CAT is the dose that elicits a bump or hive of >= to 10mm.

Intervention Type

Biological

Intervention Name(s)

Positive Control - standardized cat hair allergenic extract (CAT)

Intervention Description

4 sequential 10-fold injections starting from 0.01 BAU/mL to 10 BAU/mL

Intervention Type

Biological

Intervention Name(s)

Positive Control - Histamine Prick

Other Intervention Name(s)

Histatrol GLY

Intervention Description

1.0 mg/mL

Intervention Type

Biological

Intervention Name(s)

Negative Control - Intradermal Diluent

Intervention Description

Saline, Albumin with Phenol (HSA) sterile diluent

Primary Outcome Measure Information:

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

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: History of allergic reactivity to cats as expressed by allergic rhinitis Radioallergosorbent test (RAST test) for cat-specific IgE with RAST rating of 2 (0.70-3.49 KU/L IgE) documented within the past year or at screening Standardized cat hair allergenic extract (CAT), 10,000 BAL/mL (ALK-Abello) elicits a wheal 5 mm or greater than the diluent control (Saline Albumin with Phenol [HSA], ALK-Abello) with surrounding erythema on testing using a standardized epicutaneous delivery device (Stallergenes Prick Lancet, 1 mm tip) Histamine (Histatrol 1mg/mL, ALK-Abello) reactivity of 5 mm or greater reactivity than the diluent control with surrounding erythema on epicutaneous testing using a standardized epicutaneous delivery device Able and willing to discontinue any anti-histamine use for 5 days prior to entry into protocol and throughout the protocol participation Baseline spirometry (FEV1, FVC FEF25-75) with FEV1 >=80% predicted and other values within the normal range Ability to give written informed consent Exclusion Criteria: Diluent control (Saline Albumin with Phenol [HSA], ALK-Abello) elicits wheal >= 3 mm on epicutaneous testing using a standardized epicutaneous delivery device Pregnant females as determined by a positive serum or urine hCG test Lactating females Ever having received allergen immunotherapy (e.g., -subcutaneous allergen [SCIT] or -sublingual [SLIT]) Systemic steroids in the past 3 months Severe systemic reactivity on exposure to cats (e.g., laryngeal or angioedema, fainting, pallor, bradycardia, hypotension, bronchospasm, asthma, or generalized urticaria) A clinical history of asthma Underlying heart, liver, kidney lung, or other medical condition (acute infections, immune diseases, current substance abuse) such that the person would be at a clearly increased risk for a poor outcome should a generalized allergic reaction occur Use of systemic beta-blocking or ACE-inhibiting agents within the past 3 weeks Use of tri-cyclic antidepressants within the past 3 weeks Subjects receiving therapy with any agents known or likely to interact with adrenaline (e.g., beta blockers, ACE-Inhibitors, tri-cyclic antidepressants, or other) Current use or use of omalizumab (Xolair) within past 6 months Subjects with any extensive skin disorder (atopic dermatitis) that would make skin testing or proper interpretation impractical Mental impairment, limiting the ability to comply with study requirements Participation in a clinical trial and receipt of an investigational product within 30 days, 5 half-lives or twice the duration of the biochemical effect of the investigational product (whichever is longer) prior to dosing in the current study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andy Saxon, MD, PhD

Organizational Affiliation

University of California, Los Angeles (UCLA)

Official's Role

Study Chair

Facility Information:

Facility Name

Alfred Hospital and Monash University

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

12. IPD Sharing Statement

Links:

URL

http://www.niaid.nih.gov/Pages/default.aspx

Description

National Institute of Allergy and Infectious Diseases (NIAID)

URL

http://www.immunetolerance.org/

Description

Immune Tolerance Network (ITN)

Learn more about this trial

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

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