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

NCT01292070 | Terminated Early Phase 1 Results DMC

• 1 other identifier: DAIT ITN048AD
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Cat Allergy

Keywords

Fel d 1 protein, Felis domesticus; Injections, Intradermal

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 3 hours after the last injection of GFD

Study Arms (1)

Control-Experimental arm

EXPERIMENTAL

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).

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

Interventions

Intradermal Human Fcγ1-Fel d1 fusion protein BIOLOGICAL

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.

Control-Experimental arm

Positive Control - standardized cat hair allergenic extract (CAT) BIOLOGICAL

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

Control-Experimental arm

Positive Control - Histamine Prick BIOLOGICAL

1.0 mg/mL

Also known as: Histatrol GLY

Control-Experimental arm

Negative Control - Intradermal Diluent BIOLOGICAL

Saline, Albumin with Phenol (HSA) sterile diluent

Control-Experimental arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Immune Tolerance Network (ITN): collaborator
• Tunitas Therapeutics, Inc.: collaborator

Study Sites (1)

Alfred Hospital and Monash University

Melbourne, Victoria, 3004, Australia

Location

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID)
• Immune Tolerance Network (ITN)

Limitations and Caveats

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

• Title: Nolan Sigal, MD, PhD, CEO, Tunitas Therapeutics
• Organization: Tunitas Therapeutics

nsigal@tunitastherapeutics.com

(650) 887-4747

Study Officials

• Andy Saxon, MD, PhD

  University of California, Los Angeles

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2011
• First Posted: February 9, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 20, 2014
• Results First Posted: February 20, 2014

Record last verified: 2014-01

Locations

AU (1)