AllergyNCT02601690
Observational Analysis of T Cell Responses to SPIREs for Multiple Allergens in Subjects With Allergy in North America
An observational study of Allergy, run by Adiga Life Sciences, Inc. at 2 sites in United States.
Trial summary
This is a research study intending to look at the response of a specific type of allergy cells in the blood (called T cells) to a a type of immunotherapy product known as SPIREs (Synthetic Peptide Immuno-Regulatory Epitopes), across a broad range of subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergy
- What is being tested?
- Blood Sampling
- How many people
- 199 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2015to 25 Jun 2017
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of subjects aged from 18 to 65 years, with a documented history of allergy to one or more of the following: cat, short ragweed, Rye grass, or House Dust Mite.
Who may be able to join
- Male or female, aged 18-65 years.
- Willing and able to provide written informed consent.
- One year history of allergic rhinoconjunctivitis to one or more of cat, short ragweed, Rye grass, or HDM.
- Positive skin prick test to each allergen for which a subject has a qualifying clinical history.
Who cannot join
- Clinically relevant history of alcohol or drug abuse.
- Use of any oral or parenteral (except low dose inhaled) corticosteroids within 2 months prior to the visit or any other immunosuppressive therapy within 3 months prior to the visit.
- Vaccination/ inoculation within the 6 weeks prior to the first visit.
- A history of any significant disease or disorder (e.g. autoimmune, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment, severe atopic dermatitis).
- Subjects who have taken an investigational drug within 6 weeks prior to the visit or are currently participating in any other clinical study.
- Recent blood donation of an amount of >100 mL.
- Immunotherapy within the last 5 years to any of the allergens for which a subject would otherwise be eligible on the basis of clinical history and skin prick test result.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
O&O Alpan
Fairfax, Virginia, 22030
Empire Clinical Research
Upland, California, 91786
About this study
Official title: Observational, Cross-sectional Analysis of T Cell Responses to Synthetic Peptide Immuno-Regulatory Epitopes (SPIREs) for Multiple Allergens in Subjects With Allergy in North America
This is a research study intending to look at the response of a specific type of allergy cells in the blood (called T cells) to a a type of immunotherapy product known as SPIREs (Synthetic Peptide Immuno-Regulatory Epitopes), across a broad range of subjects. This is a non-interventional study in which no investigational product will be administered to any subject.
- Conditions
- Allergy
- Being tested
- Blood Sampling
- Keywords
- Rye Grass, Ragweed, Cat, House Dust Mite
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SamplingOther
| Study group | Role | What they receive |
|---|---|---|
| Blood Sampling | Participants allergic to one or more of cat, rye grass, ragweed or house dust mite. Receives: Other: Blood Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of T cell responses to SPIREs
Measured: 2 years
Secondary outcomes (1)
Characterization of the distribution of allergen sensitivity across a broad range of common allergens
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startOct 2015
- Primary completion25 Jun 2017
- Study completion25 Jun 2017
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiga Life Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Circassia Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601690
- Sponsor's protocol ID
- RES-010
- Status last verified
- Apr 2019
- First submitted
- 9 Nov 2015
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Cross-sectional Analysis of T Cell Responses to Synthetic Peptide Immuno-Regulatory Epitopes (SPIREs) for Multiple Allergens in Subjects With Allergy in North America
- ClinicalTrials.gov ID
- NCT02601690
- Acronym / sponsor ID
- RES-010
- Conditions
- Allergy
- Keywords
- Rye Grass, Ragweed, Cat, House Dust Mite
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Adiga Life Sciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Circassia Limited
- Study start
- Oct 2015 (actual)
- Primary completion
- 25 Jun 2017 (actual)
- Study completion
- 25 Jun 2017 (actual)
- First posted
- 10 Nov 2015 (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.
This is a research study intending to look at the response of a specific type of allergy cells in the blood (called T cells) to a a type of immunotherapy product known as SPIREs (Synthetic Peptide Immuno-Regulatory Epitopes), across a broad range of subjects. This is a non-interventional study in which no investigational product will be administered to any subject.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood Sampling | – | Other: Blood SamplingParticipants allergic to one or more of cat, rye grass, ragweed or house dust mite. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of subjects aged from 18 to 65 years, with a documented history of allergy to one or more of the following: cat, short ragweed, Rye grass, or House Dust Mite.
Key inclusion criteria (4 listed)
- Male or female, aged 18-65 years.
- Willing and able to provide written informed consent.
- One year history of allergic rhinoconjunctivitis to one or more of cat, short ragweed, Rye grass, or HDM.
- Positive skin prick test to each allergen for which a subject has a qualifying clinical history.
Key exclusion criteria (7 listed)
- Clinically relevant history of alcohol or drug abuse.
- Use of any oral or parenteral (except low dose inhaled) corticosteroids within 2 months prior to the visit or any other immunosuppressive therapy within 3 months prior to the visit.
- Vaccination/ inoculation within the 6 weeks prior to the first visit.
- A history of any significant disease or disorder (e.g. autoimmune, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment, severe atopic dermatitis).
- Subjects who have taken an investigational drug within 6 weeks prior to the visit or are currently participating in any other clinical study.
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 |
|---|---|---|
| Blood Sampling | Other | Blood Sampling |
Primary outcome
Evaluation of T cell responses to SPIREs
Time frame: 2 years
1 secondary outcome
Characterization of the distribution of allergen sensitivity across a broad range of common allergens
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy, run by Adiga Life Sciences, Inc. at 2 sites in United States.
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 4 inclusion and 7 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 9 Apr 2019. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
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?
Evaluation of T cell responses to SPIREs (time frame: 2 years). 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 9 Apr 2019.