Cat AllergyEarly Phase 1NCT01292070
Safety Evaluation of an Experimental Treatment, Intradermal Human Fcγ1-Fel d1 Fusion Protein (GFD), for Cat Allergy
A Early Phase 1 study testing Intradermal Human Fcγ1-Fel d1 fusion protein in people with Cat Allergy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cat Allergy
- What is being tested?
- Intradermal Human Fcγ1-Fel d1 fusion protein
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2011to Apr 2011
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Alfred Hospital and Monash University
Melbourne, Victoria, 3004
About this study
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
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.
Read the 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.
- Conditions
- Cat Allergy
- Being tested
- Intradermal Human Fcγ1-Fel d1 fusion protein, Positive Control - standardized cat hair allergenic extract (CAT), Positive Control - Histamine Prick, Negative Control - Intradermal Diluent
- Keywords
- Fel d 1 protein, Felis domesticus, Injections, Intradermal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradermal Human Fcγ1-Fel d1 fusion proteinBiological
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.
Positive Control - standardized cat hair allergenic extract (CAT)Biological
4 sequential 10-fold injections starting from 0.01 BAU/mL to 10 BAU/mL
Positive Control - Histamine PrickBiological
Also called Histatrol GLY
1.0 mg/mL
Negative Control - Intradermal DiluentBiological
Saline, Albumin with Phenol (HSA) sterile diluent
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 hours after the last injection of GFD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cat AllergyStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN), Tunitas Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Andy Saxon, MD, PhD, Study chair, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292070
- Sponsor's protocol ID
- DAIT ITN048AD
- Status last verified
- Jan 2014
- First submitted
- 7 Feb 2011
- Last updated
- 20 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01292070
- Acronym / sponsor ID
- DAIT ITN048AD
- Conditions
- Cat Allergy
- Keywords
- Fel d 1 protein, Felis domesticus, Injections, Intradermal
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 4 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN), Tunitas Therapeutics, Inc.
- Study start
- Mar 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Posted 20 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control-Experimental arm | Experimental | 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 DiluentEach 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradermal Human Fcγ1-Fel d1 fusion proteinPart 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. | Biological | Control-Experimental arm |
| Positive Control - standardized cat hair allergenic extract (CAT)4 sequential 10-fold injections starting from 0.01 BAU/mL to 10 BAU/mL | Biological | Control-Experimental arm |
| Positive Control - Histamine PrickAlso: Histatrol GLY1.0 mg/mL | Biological | Control-Experimental arm |
| Negative Control - Intradermal DiluentSaline, Albumin with Phenol (HSA) sterile diluent | Biological | Control-Experimental arm |
Primary outcome
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Immune Tolerance Network (ITN)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andy Saxon, MD, PhD study chair
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intradermal Human Fcγ1-Fel d1 fusion protein in people with Cat Allergy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2014.