Cat Allergy (Disorder)Phase 2NCT01740024
Biological Potency of the Cat Epithelial Allergenic Extracts
A Phase 2 study testing 1 (Dose Response Skin Prick Tests) in people with Cat Allergy (Disorder), run by Laboratorios Leti, S.L. at 2 sites in Spain.
Trial summary
The primary objective of this clinical trial is to quantify the loss of in vivo biological potency of a depigmented polymerized (DPP) allergenic cat epithelial extract versus the native allergenic extract (N). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cat Allergy (Disorder)
- What is being tested?
- 1 (Dose Response Skin Prick Tests)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesSpain
- Study dates
- Nov 2012to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A subject will be eligible for inclusion in the study only if all of the following criteria are met:
- The subject (and/or legal representative, where applicable) has given written, signed and dated informed consent.
- Subjects of either sex and of any race or ethnic group.
- Age > 18 years and < 60 years on the day of inclusion in the study.
- Positive clinical history of allergy to cat epithelia (i.e., rhinitis, conjunctivitis, rhinoconjunctivitis, asthma, urticaria, etc. ).
- A positive prick-test (mean diameter of papule ≥ 3 mm or area of papule ≥ 7 mm2) with a commercial extract of cat epithelium. The results of the prick-test will be valid if they were obtained in the year prior to inclusion of the subject in the study.
- A positive specific IgE test (> 0.70 KU/l) for cat epithelium. The results of the IgE test will be valid if they were obtained in the year prior to inclusion of the subject in the study.
Who cannot join
- A subject will NOT be eligible for inclusion in the study if any of the following criteria are met:
- Immunotherapy in the last 5 years involving allergens known to be able to interfere with the test allergen (e.g., cat extract).
- Use of drugs that can interfere with the skin response before and during the study (e.g., antihistamines), within the intervals established in section 9.1 and appendix 1.
- Treatment with any of the following medicines: tricyclic or tetracyclic antidepressants or MAOIs (Monoamine oxidase inhibitors), beta-blockers or chronic use of oral corticosteroids or use of corticosteroids via either the oral or the parenteral route in repeated and intermittent dosing regimens (> 10 mg/day of prednisone or equivalent).
- Pregnant or nursing women and women with a positive pregnancy test in visit 2.
- Dermographism affecting the skin of the test site, in either of the two visits to the study centre.
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- Atopic dermatitis affecting the skin of the test site, in either of the two visits to the study centre.
- Urticaria affecting the skin of the test site, in either of the two visits to the study centre.
- Clinically relevant immune system diseases (both autoimmune disorders and immune deficiencies). (Hashimoto's thyroiditis with hypothyroidism well controlled through thyroid hormone therapy does not necessarily represent a contraindication. Graves' disease (hyperthyroidism) would be an exclusion criterion due to the potential risk in the event adrenaline must be used.)
- Serious uncontrolled diseases that may increase the safety risk of the subjects participating in the study, including but not limited to the following: heart failure, serious or uncontrolled respiratory diseases, endocrine disorders, clinically relevant liver or kidney diseases, or haematological disorders.
- Patents with diseases or conditions that limit adrenaline use (coronary disease, severe arterial hypertension, etc.).
- Serious psychiatric, psychological or neurological problems.
- Medication, alcohol or illegal drug abuse in the last year.
- Participation in any other clinical trial during the 30 days (or 5 times the biological half-life of the investigational product - whichever is longest) prior to inclusion of the subject in this study.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital El Tomillar - Area Hospitalaria de Valme
Dos Hermanas, Sevilla, Sevilla / Andalucia, 41700
Fundación Jimenez Diaz
Madrid, Madrid / Madrid, 28005
About this study
Official title: An Open-label, Multicentre Study Comparing the Biological Potency of the Native, Depigmented and Depigmented Polymerized Cat Epithelial Allergenic Extracts.
The primary objective of this clinical trial is to quantify the loss of in vivo biological potency of a depigmented polymerized (DPP) allergenic cat epithelial extract versus the native allergenic extract (N).
Read the detailed description
This is an open-label, non-randomized phase II clinical trial.
Three different concentrations of three different cat epithelial allergenic extracts, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride and a glycerated phenol saline solution, respectively, will be tested in every subject on the volar surface of the forearm.
- Conditions
- Cat Allergy (Disorder)
- Being tested
- 1 (Dose Response Skin Prick Tests)
- Keywords
- Immunotherapy, Subcutaneous immunotherapy, Skin Prick Test, Dose Response Prick Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 (Dose Response Skin Prick Tests)Biological
3 different cat epithelium allergenic extracts at 3 different concentrations, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
| Study group | Role | What they receive |
|---|---|---|
| 1 (Dose-Response Skin Prick Tests) | Experimental | 3 different cat epithelium allergenic extracts at 3 different concentrations Positive control Negative control Receives: Biological: 1 (Dose Response Skin Prick Tests) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheal size area (mm2)elicited on the skin after the dose-response prick-test
Wheal size area (mm2)elicited on the skin after the dose-response prick-test, in duplicate, of the native and depigmented polymerized cat epithelial allergenic extracts, together with the area of the wheals induced by the positive and negative controls.
Measured: Test sites should be inspected and recorded 15-20 min after application
Secondary outcomes (4)
Wheal size area (mm2)elicited on the skin after the dose-response prick-test
Wheal size area (mm2)elicited on the skin after the dose-response prick-test, in duplicate, of the native and depigmented cat epithelial allergenic extracts, together with the area of the wheals induced by the positive and negative controls.
Measured: Test sites should be inspected and recorded 15-20 min after application
Wheal siza area (mm2)elicited on the skin after the dose-response prick-test
Wheal siza area (mm2)elicited on the skin after the dose-response prick-test, in duplicate, of the depigmented and depigmented polymerized cat epithelial allergenic extracts, together with the area of the wheals induced by the positive and negative controls.
Measured: Test sites should be inspected and recorded 15-20 min after application
Determine the HEP dose of the native (N) cat epithelial allergenic extract
Calculation will be made of the 10 HEP dose of the native (N) cat epithelial allergenic extract.
Measured: Wheals will be elicited in visit 2. CRFs will be retrieved, measured in-house and filed back in the site before study closure (maximum 3 months after being elicited).
Loss of in vitro potency of the cat epithelial allergenic extracts
To quantify the loss of in vitro potency of cat epithelial allergenic extracts, based on specific IgE and IgG inhibition studies.
Measured: Blood will be collected in visit 2. Serum samples will be analyze once every sample is received. The samples will be analyzed at most 12 months after received
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cat Allergy (Disorder)Studies of the same condition, open and under way.
- 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
- Phase 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Leti, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lena M Erbiti, Study chair, Laboratorios LETI, S.L.Unipersonal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740024
- Sponsor's protocol ID
- 206-PG-PRI-190
- Other IDs
- 2012-001931-30
- Status last verified
- Nov 2012
- First submitted
- 13 Nov 2012
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicentre Study Comparing the Biological Potency of the Native, Depigmented and Depigmented Polymerized Cat Epithelial Allergenic Extracts.
- ClinicalTrials.gov ID
- NCT01740024
- Acronym / sponsor ID
- 206-PG-PRI-190
- Conditions
- Cat Allergy (Disorder)
- Keywords
- Immunotherapy, Subcutaneous immunotherapy, Skin Prick Test, Dose Response Prick Test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Laboratorios Leti, S.L.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this clinical trial is to quantify the loss of in vivo biological potency of a depigmented polymerized (DPP) allergenic cat epithelial extract versus the native allergenic extract (N).
Detailed description
This is an open-label, non-randomized phase II clinical trial.
Three different concentrations of three different cat epithelial allergenic extracts, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride and a glycerated phenol saline solution, respectively, will be tested in every subject on the volar surface of the forearm.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 (Dose-Response Skin Prick Tests) | Experimental | Biological: 1 (Dose Response Skin Prick Tests)3 different cat epithelium allergenic extracts at 3 different concentrations Positive control Negative control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- A subject will be eligible for inclusion in the study only if all of the following criteria are met:
- The subject (and/or legal representative, where applicable) has given written, signed and dated informed consent.
- Subjects of either sex and of any race or ethnic group.
- Age > 18 years and < 60 years on the day of inclusion in the study.
- Positive clinical history of allergy to cat epithelia (i.e., rhinitis, conjunctivitis, rhinoconjunctivitis, asthma, urticaria, etc. ).
Key exclusion criteria (14 listed)
- A subject will NOT be eligible for inclusion in the study if any of the following criteria are met:
- Immunotherapy in the last 5 years involving allergens known to be able to interfere with the test allergen (e.g., cat extract).
- Use of drugs that can interfere with the skin response before and during the study (e.g., antihistamines), within the intervals established in section 9.1 and appendix 1.
- Treatment with any of the following medicines: tricyclic or tetracyclic antidepressants or MAOIs (Monoamine oxidase inhibitors), beta-blockers or chronic use of oral corticosteroids or use of corticosteroids via either the oral or the parenteral route in repeated and intermittent dosing regimens (> 10 mg/day of prednisone or equivalent).
- Pregnant or nursing women and women with a positive pregnancy test in visit 2.
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 |
|---|---|---|
| 1 (Dose Response Skin Prick Tests)3 different cat epithelium allergenic extracts at 3 different concentrations, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm. | Biological | 1 (Dose-Response Skin Prick Tests) |
Primary outcome
Wheal size area (mm2)elicited on the skin after the dose-response prick-test
Time frame: Test sites should be inspected and recorded 15-20 min after application
Wheal size area (mm2)elicited on the skin after the dose-response prick-test, in duplicate, of the native and depigmented polymerized cat epithelial allergenic extracts, together with the area of the wheals induced by the positive and negative controls.
4 secondary outcomes
Wheal size area (mm2)elicited on the skin after the dose-response prick-test
Time frame: Test sites should be inspected and recorded 15-20 min after application
Wheal siza area (mm2)elicited on the skin after the dose-response prick-test
Time frame: Test sites should be inspected and recorded 15-20 min after application
Determine the HEP dose of the native (N) cat epithelial allergenic extract
Time frame: Wheals will be elicited in visit 2. CRFs will be retrieved, measured in-house and filed back in the site before study closure (maximum 3 months after being elicited).
Loss of in vitro potency of the cat epithelial allergenic extracts
Time frame: Blood will be collected in visit 2. Serum samples will be analyze once every sample is received. The samples will be analyzed at most 12 months after received
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
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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.
Lena M Erbiti study chair
Laboratorios LETI, S.L.Unipersonal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1 (Dose Response Skin Prick Tests) in people with Cat Allergy (Disorder), run by Laboratorios Leti, S.L. at 2 sites in Spain.
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 14 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: finished, as of the sponsor's last update on 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Wheal size area (mm2)elicited on the skin after the dose-response prick-test (time frame: Test sites should be inspected and recorded 15-20 min after application). 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 22 May 2014.