Allergic RhinitisPhase 2NCT00670384
Phase 2 Study in Adults Sensitized to Short Ragweed
A Phase 2 study testing Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia) in people with Allergic Rhinitis, run by Antigen Laboratories, Inc..
Trial summary
The purpose of this study is to identify an effective dose of allergen-specific immunotherapy for short ragweed (Ambrosia artemisiifolia) administered by an oral/sublingual route. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients between the ages of 18 and 55 years (inclusive.
- Written informed consent to participate in the study.
- Documented allergy to short ragweed pollen as demonstrated by a positive epicutaneous skin test (wheal >3 mm) and symptoms of allergic rhinitis during the two previous short ragweed seasons.
- Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from screening through the 4 week follow-up period following the last dose of Clinical Trial Material (CTM): hormonal (oral, implant, or injection) begun >30 days prior to screening, barrier (condom, diaphragm with spermicide), Intrauterine Device (IUD), or vasectomized partner (6 months minimum).
- No clinically significant abnormal findings on the physical examination, with the exception of head, eyes, ears, nose and throat (HEENT) findings consistent with allergic rhinitis, medical history, or clinical laboratory results during screening which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
Who cannot join
- Previous allergen immunotherapy (subcutaneous immunotherapy (SCIT), oral immunotherapy, sublingual immunotherapy (SLIT), or recombinant peptide) for short ragweed within 24 months of the Screening Visit.
- History of severe allergic reaction requiring medical intervention.
- Intolerance of or severe allergic reaction to previous immunotherapy (SCIT, oral immunotherapy, SLIT, or recombinant peptide).
- Allergy to any of the non-antigen ingredients in the study drug formulation, including, but not limited to, Food, Drug and Cosmetic (FD\&C) Yellow #5, sodium chloride, sodium bicarbonate, and glycerine.
- History of asthma requiring daily medication.
- Subjects receiving anti-IgE monoclonal antibodies.
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- Congenital immune deficiency or acquired immune suppression. Causes of acquired immune suppression may include, but are not limited to, systemic illnesses such as malignancy and infection, the use of medications such as corticosteroids and chemotherapeutic agents, and radiation therapy.
- History of organ transplant, hematologic malignancy, autoimmune disease, myocardial infarction, or congestive heart failure.
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, psychiatric, or cardiovascular disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Inability or unwillingness to stop using drugs that may inhibit the wheal-and-flare reaction or rhinitic response prior to the study and for the duration of dosing CTM (with the exception of protocol-specified rescue medications provided by the study site for use after Study Day 0).
- Inability or unwillingness to stop using drugs that may inhibit the ability to treat a severe allergic adverse event. This includes, but is not limited to: beta blockers such as atenolol (Tenormin), metoprolol (Lopressor, Toprol-XL) and propranolol (Inderal, Inderal LA) for 14 days prior to Study Day 0 and for the duration of the study
- Female subjects who are trying to conceive, are pregnant, or are lactating.
- Positive serum pregnancy test at screening or a positive human chorionic gonadotropin (HCG) urine test on Study Day 0 prior to administration of study drug for women of childbearing potential.
- Positive blood screen for HIV, Hepatitis B surface antigen (HbSAg), or Hepatitis C.
- History of alcohol or drug abuse within the year prior to the Screening Visit, or current evidence of substance dependence or abuse.
- Participation in a clinical trial or receipt of a non-FDA approved therapy within 30 days prior to the Screening Visit.
About this study
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study of Sublingual Immunotherapy in Adults Sensitized to the Standardized Allergenic Extract, Short Ragweed (Ambrosia Artemisiifolia)
The purpose of this study is to identify an effective dose of allergen-specific immunotherapy for short ragweed (Ambrosia artemisiifolia) administered by an oral/sublingual route.
- Conditions
- Allergic Rhinitis
- Being tested
- Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia), Placebo
- Keywords
- SLIT, Immunotherapy, Short ragweed, SAR, Seasonal allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia)Biological
Sublingual drops
PlaceboBiological
Sublingual drops
| Study group | Role | What they receive |
|---|---|---|
| Dose Group A | Active comparator | Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia) Receives: Biological: Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia) |
| Dose Group B | Active comparator | Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia) Receives: Biological: Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia) |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average of Total Symptom Scores
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
Why it stopped: No funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antigen Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670384
- Sponsor's protocol ID
- ALI001-08
- Status last verified
- Jan 2014
- First submitted
- 29 Apr 2008
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study of Sublingual Immunotherapy in Adults Sensitized to the Standardized Allergenic Extract, Short Ragweed (Ambrosia Artemisiifolia)
- ClinicalTrials.gov ID
- NCT00670384
- Acronym / sponsor ID
- ALI001-08
- Conditions
- Allergic Rhinitis
- Keywords
- SLIT, Immunotherapy, Short ragweed, SAR, Seasonal allergic rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Antigen Laboratories, Inc.Industry (pharma, biotech, devices)
- First posted
- 1 May 2008 (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 purpose of this study is to identify an effective dose of allergen-specific immunotherapy for short ragweed (Ambrosia artemisiifolia) administered by an oral/sublingual route.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Group A | Active comparator | Biological: Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia)Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia) |
| Dose Group B | Active comparator | Biological: Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia)Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia) |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female patients between the ages of 18 and 55 years (inclusive.
- Written informed consent to participate in the study.
- Documented allergy to short ragweed pollen as demonstrated by a positive epicutaneous skin test (wheal >3 mm) and symptoms of allergic rhinitis during the two previous short ragweed seasons.
- Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from screening through the 4 week follow-up period following the last dose of Clinical Trial Material (CTM): hormonal (oral, implant, or injection) begun >30 days prior to screening, barrier (condom, diaphragm with spermicide), Intrauterine Device (IUD), or vasectomized partner (6 months minimum).
- No clinically significant abnormal findings on the physical examination, with the exception of head, eyes, ears, nose and throat (HEENT) findings consistent with allergic rhinitis, medical history, or clinical laboratory results during screening which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
Key exclusion criteria (16 listed)
- Previous allergen immunotherapy (subcutaneous immunotherapy (SCIT), oral immunotherapy, sublingual immunotherapy (SLIT), or recombinant peptide) for short ragweed within 24 months of the Screening Visit.
- History of severe allergic reaction requiring medical intervention.
- Intolerance of or severe allergic reaction to previous immunotherapy (SCIT, oral immunotherapy, SLIT, or recombinant peptide).
- Allergy to any of the non-antigen ingredients in the study drug formulation, including, but not limited to, Food, Drug and Cosmetic (FD\&C) Yellow #5, sodium chloride, sodium bicarbonate, and glycerine.
- History of asthma requiring daily medication.
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 |
|---|---|---|
| Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia)Sublingual drops | Biological | Dose Group A, Dose Group B |
| PlaceboSublingual drops | Biological | Placebo |
Primary outcome
Average of Total Symptom Scores
Time frame: 20 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia) in people with Allergic Rhinitis, run by Antigen Laboratories, Inc..
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 5 inclusion and 16 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: withdrawn, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Average of Total Symptom Scores (time frame: 20 weeks). 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 Jan 2014.