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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01292070




Registration number
NCT01292070
Ethics application status
Date submitted
7/02/2011
Date registered
9/02/2011
Date last updated
20/02/2014

Titles & IDs
Public title
Safety Evaluation of an Experimental Treatment, Intradermal Human Fc?1-Fel d1 Fusion Protein (GFD), for Cat Allergy
Scientific title
A Dose-Escalating Phase 0 Study to Evaluate the Safety and Local Cutaneous Reactivity of Intradermal Human Fc?1-Fel d1 Fusion Protein (GFD) in Cat-allergic Healthy Volunteers
Secondary ID [1] 0 0
DAIT ITN048AD
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cat Allergy 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Intradermal Human Fc?1-Fel d1 fusion protein
Other interventions - Positive Control - standardized cat hair allergenic extract (CAT)
Other interventions - Positive Control - Histamine Prick
Other interventions - Negative Control - Intradermal Diluent

Experimental: Control-Experimental arm - 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).


Other interventions: Intradermal Human Fc?1-Fel d1 fusion protein
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.

Other interventions: Positive Control - standardized cat hair allergenic extract (CAT)
4 sequential 10-fold injections starting from 0.01 BAU/mL to 10 BAU/mL

Other interventions: Positive Control - Histamine Prick
1.0 mg/mL

Other interventions: Negative Control - Intradermal Diluent
Saline, Albumin with Phenol (HSA) sterile diluent

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
up to 3 hours after the last injection of GFD

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital and Monash University - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
National Institute of Allergy and Infectious Diseases (NIAID)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Immune Tolerance Network (ITN)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Tunitas Therapeutics, Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this trial is to show that Intradermal Human Fc?1-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.
Trial website
https://clinicaltrials.gov/show/NCT01292070
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andy Saxon, MD, PhD
Address 0 0
University of California, Los Angeles (UCLA)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01292070