Rhinitis, Allergic, SeasonalPhase 2NCT00537355
An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber
A Phase 2 study testing Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate and Histamine in people with Rhinitis, Allergic, Seasonal, run by Dynavax Technologies Corporation at 6 sites in Canada.
Trial summary
This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study. After passing the initial Screening Visit, subjects will be in the environmental exposure chamber(EEC), a room with a controlled amount of ragweed pollen, for 4 hours each day on 4 consecutive days. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate and Histamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 271 participants
- Where
- 6 sitesCanada
- Study dates
- Sep 2007to May 2008
- 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
- Is willing and able to give signed informed consent, and must have provided this consent.
- Has a clinical history of seasonal allergic rhinitis with seasonal nasal allergy symptoms during each of the last 2 ragweed allergy seasons.
- Has documentation of a positive skin test to ragweed allergen within 12 months of screening.
- Has minimum qualifying symptom scores at the last visit of the Pre-Treatment EEC sessions (Visit 5, Day 4).
- If female of childbearing potential, is not pregnant and is consistently using an acceptable birth control method.
- Is normally active and otherwise judged to be in good health on the basis of medical history, physical examination and routine laboratory tests.
Who cannot join
- A woman who is pregnant, breastfeeding, or planning a pregnancy.
- Has a history of more than mild asthma that requires the use of a daily inhaled or oral corticosteroid, leukotriene inhibitor, or cromolyn; or a daily inhaled short or long acting β-agonist.
- Has had any hospital admissions for asthma, a recent (within the past 12 months)asthma exacerbation that required either oral or inhaled corticosteroids, or a prior history of unstable asthma.
- Has received immunotherapy within the last 2 years that has contained ragweed pollen extract.
- Has previously participated in a clinical trial with TOLAMBA or another ragweed-based immunotherapy.
- Has received immunotherapy for any allergens within 30 days prior to Visit 1.
Show all 16Show fewer
- Has the need for use of antihistamines or corticosteroids on a regular basis (systemic or topical).
- Has received anti-immunoglobulin E (IgE) antibody (Xolair®) within the past 12 months.
- Is currently taking monoamine oxidase (MAO) inhibitors.
- Has taken any systemic corticosteroids, immunomodulators, or immune suppressive medications within 4 weeks prior to Visit 1.
- Has taken any antihistamine within 7 days prior to Visit 1 skin testing.
- Requires use of β-adrenergic blockers or other agents that may interfere with the use of adrenaline.
- Known current alcohol or drug abuse.
- Current participation in another clinical study involving an investigational drug or device, or participation in such a study within 30 days prior to Visit 1.
- Has a history of generalized anaphylaxis requiring medical attention.
- Has moderate or severe allergy symptoms at Visit 1.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Allied Research International Inc.
Mississauga, Ontario, L4W 1N2
Alpha Medical Research Inc.
Mississauga, Ontario, L5A 3V4
Division of Clinical Immunology and Allergy, The McGill University Health Centre
Montreal, Quebec, H3G 1A4
Anapharm
Montreal, Quebec, H3X 2H9
Allergy & Asthma Research Centre
Ottawa, Ontario, K1Y 4G2
Centre De Recherche Appliquée en Allergie De Québec
Québec, Quebec, GIV 4M6
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of TOLAMBA™ in the Control of Symptoms of Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Model
This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study. After passing the initial Screening Visit, subjects will be in the environmental exposure chamber(EEC), a room with a controlled amount of ragweed pollen, for 4 hours each day on 4 consecutive days. At the last visit, subjects who have achieved a minimum Total Nasal Symptom Score (TNSS) will be randomized to receive either TOLAMBA or placebo treatments. Subjects will receive 6 weekly subcutaneous (under the skin) injections of the study drug. About three weeks after the last injection, subjects will be asked to be in the EEC for 2 consecutive days (Visits 11 and 12, Days 60 and 61). Approximately 3 weeks after Visit 12 (Day 61), the subjects will again be in the EEC for 4 consecutive days (Visits 13-16, Days 82-85).
During all EEC visits, the subjects will be exposed to ragweed pollen at an average concentration of 3500 ± 500 pollen grains per cubic meter. Each EEC visit will last 4 hours. During each EEC visit, patients will be asked to record symptom scores for nasal and non-nasal symptoms at scheduled time points.
The total duration of a subject's participation in this study is expected to be a minimum of 85 days.
Read the detailed description
Ragweed allergy is the most common seasonal allergy in North America. Allergen immunotherapy is a therapeutic option for patients who have allergy symptoms that cannot be adequately controlled by avoidance of the allergen or medication. It may also be appropriate for those who cannot tolerate their medications due to side effects or have difficulties with medication compliance.
This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study. After passing the initial Screening Visit, subjects will be in the environmental exposure chamber(EEC), a room with a controlled amount of ragweed pollen, for 4 hours each day on 4 consecutive days. At the last visit, subjects who have achieved a minimum Total Nasal Symptom Score (TNSS) will be randomized to receive either TOLAMBA or placebo treatments. Subjects will receive 6 weekly subcutaneous (under the skin) injections of the study drug. About three weeks after the last injection, subjects will be asked to be in the EEC for 2 consecutive days (Visits 11 and 12, Days 60 and 61). Approximately 3 weeks after Visit 12 (Day 61), the subjects will again be in the EEC for 4 consecutive days (Visits 13-16, Days 82-85).
During all EEC visits, the subjects will be exposed to ragweed pollen at an average concentration of 3500 ± 500 pollen grains per cubic meter. Each EEC visit will last 4 hours. During each EEC visit, patients will be asked to record symptom scores for nasal and non-nasal symptoms at scheduled time points.
The total duration of a subject's participation in this study is expected to be a minimum of 85 days.
Comparison: Allergy symptoms of subjects treated with TOLAMBA™ compared with subjects treated with placebo.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate, Histamine
- Keywords
- ragweed, ragweed allergy, allergy, allergies, allergic, seasonal allergic rhinitis, allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Hypersensitivity, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amb a 1 Immunostimulatory Oligoribonucleotide ConjugateBiological
Also called TOLAMBA™
6 weekly subcutaneous injections (escalating doses of 3 mcg to 30 mcg)
HistamineDrug
Also called Histatrol
6 weekly subcutaneous injections (escalating doses of 0.22 mcg to 1.1 mcg)
| Study group | Role | What they receive |
|---|---|---|
| TOLAMBA™ | Active comparator | Not described Receives: Biological: Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate |
| Histamine | Sham comparator | Histamine simulates mild redness/swelling effect seen with active comparator, TOLAMBA™. Prevents study staff from easily identifying subjects who received active comparator. Receives: Drug: Histamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score (TNSS)
Measured: 3 months
Secondary outcomes (3)
Total Non-Nasal Symptom Score (TNNSS)
Measured: 3 months
Total Symptom Score (TSS)
Measured: 3 months
quality of life questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, SeasonalStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynavax Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eduardo Martins, MD, DPhil, Study director, Dynavax Technologies Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537355
- Sponsor's protocol ID
- DV1-SAR-11
- Status last verified
- Apr 2019
- First submitted
- 27 Sep 2007
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The IND for Tolamba was withdrawn. There is no intention to conduct clinical studies with this compound. All studies were conducted in Canada, no U.S. sites participated in study. CT PRS states "DR" status will be removed from study. 3/1/2017 - no update
Publications
Campbell JD, Buchmann P, Kesting S, Cunningham CR, Coffman RL, Hessel EM. Allergen-specific T cell responses to immunotherapy monitored by CD154 and intracellular cytokine expression. Clin Exp Allergy. 2010 Jul;40(7):1025-35. doi: 10.1111/j.1365-2222.2010.03505.x. Epub 2010 Apr 13.
PubMed 20412135
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of TOLAMBA™ in the Control of Symptoms of Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Model
- ClinicalTrials.gov ID
- NCT00537355
- Acronym / sponsor ID
- DV1-SAR-11
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- ragweed, ragweed allergy, allergy, allergies, allergic, seasonal allergic rhinitis, allergic rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Dynavax Technologies CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 1 Oct 2007 (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 will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study. After passing the initial Screening Visit, subjects will be in the environmental exposure chamber(EEC), a room with a controlled amount of ragweed pollen, for 4 hours each day on 4 consecutive days. At the last visit, subjects who have achieved a minimum Total Nasal Symptom Score (TNSS) will be randomized to receive either TOLAMBA or placebo treatments. Subjects will receive 6 weekly subcutaneous (under the skin) injections of the study drug. About three weeks after the last injection, subjects will be asked to be in the EEC for 2 consecutive days (Visits 11 and 12, Days 60 and 61). Approximately 3 weeks after Visit 12 (Day 61), the subjects will again be in the EEC for 4 consecutive days (Visits 13-16, Days 82-85).
During all EEC visits, the subjects will be exposed to ragweed pollen at an average concentration of 3500 ± 500 pollen grains per cubic meter. Each EEC visit will last 4 hours. During each EEC visit, patients will be asked to record symptom scores for nasal and non-nasal symptoms at scheduled time points.
The total duration of a subject's participation in this study is expected to be a minimum of 85 days.
Detailed description
Ragweed allergy is the most common seasonal allergy in North America. Allergen immunotherapy is a therapeutic option for patients who have allergy symptoms that cannot be adequately controlled by avoidance of the allergen or medication. It may also be appropriate for those who cannot tolerate their medications due to side effects or have difficulties with medication compliance.
This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study. After passing the initial Screening Visit, subjects will be in the environmental exposure chamber(EEC), a room with a controlled amount of ragweed pollen, for 4 hours each day on 4 consecutive days. At the last visit, subjects who have achieved a minimum Total Nasal Symptom Score (TNSS) will be randomized to receive either TOLAMBA or placebo treatments. Subjects will receive 6 weekly subcutaneous (under the skin) injections of the study drug. About three weeks after the last injection, subjects will be asked to be in the EEC for 2 consecutive days (Visits 11 and 12, Days 60 and 61). Approximately 3 weeks after Visit 12 (Day 61), the subjects will again be in the EEC for 4 consecutive days (Visits 13-16, Days 82-85).
During all EEC visits, the subjects will be exposed to ragweed pollen at an average concentration of 3500 ± 500 pollen grains per cubic meter. Each EEC visit will last 4 hours. During each EEC visit, patients will be asked to record symptom scores for nasal and non-nasal symptoms at scheduled time points.
The total duration of a subject's participation in this study is expected to be a minimum of 85 days.
Comparison: Allergy symptoms of subjects treated with TOLAMBA™ compared with subjects treated with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOLAMBA™ | Active comparator | Biological: Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate |
| Histamine | Sham comparator | Drug: HistamineHistamine simulates mild redness/swelling effect seen with active comparator, TOLAMBA™. Prevents study staff from easily identifying subjects who received active comparator. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Is willing and able to give signed informed consent, and must have provided this consent.
- Has a clinical history of seasonal allergic rhinitis with seasonal nasal allergy symptoms during each of the last 2 ragweed allergy seasons.
- Has documentation of a positive skin test to ragweed allergen within 12 months of screening.
- Has minimum qualifying symptom scores at the last visit of the Pre-Treatment EEC sessions (Visit 5, Day 4).
- If female of childbearing potential, is not pregnant and is consistently using an acceptable birth control method.
Key exclusion criteria (16 listed)
- A woman who is pregnant, breastfeeding, or planning a pregnancy.
- Has a history of more than mild asthma that requires the use of a daily inhaled or oral corticosteroid, leukotriene inhibitor, or cromolyn; or a daily inhaled short or long acting β-agonist.
- Has had any hospital admissions for asthma, a recent (within the past 12 months)asthma exacerbation that required either oral or inhaled corticosteroids, or a prior history of unstable asthma.
- Has received immunotherapy within the last 2 years that has contained ragweed pollen extract.
- Has previously participated in a clinical trial with TOLAMBA or another ragweed-based immunotherapy.
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 |
|---|---|---|
| Amb a 1 Immunostimulatory Oligoribonucleotide ConjugateAlso: TOLAMBA™6 weekly subcutaneous injections (escalating doses of 3 mcg to 30 mcg) | Biological | TOLAMBA™ |
| HistamineAlso: Histatrol6 weekly subcutaneous injections (escalating doses of 0.22 mcg to 1.1 mcg) | Drug | Histamine |
Primary outcome
Total Nasal Symptom Score (TNSS)
Time frame: 3 months
3 secondary outcomes
Total Non-Nasal Symptom Score (TNNSS)
Time frame: 3 months
Total Symptom Score (TSS)
Time frame: 3 months
quality of life questionnaire
Time frame: 3 months
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 16 Apr 2019.
- Derived from this study: PubMed 20412135Campbell JD, Buchmann P, Kesting S, Cunningham CR, Coffman RL, Hessel EM. Allergen-specific T cell responses to immunotherapy monitored by CD154 and intracellular cytokine expression. Clin Exp Allergy. 2010 Jul;40(7):1025-35. doi: 10.1111/j.1365-2222.2010.03505.x. Epub 2010 Apr 13.
- sponsor websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. The IND for Tolamba was withdrawn. There is no intention to conduct clinical studies with this compound. All studies were conducted in Canada, no U.S. sites participated in study. CT PRS states "DR" status will be removed from study. 3/1/2017 - no update
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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.
Eduardo Martins, MD, DPhil study director
Dynavax Technologies Corporation
6 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 Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate and Histamine in people with Rhinitis, Allergic, Seasonal, run by Dynavax Technologies Corporation at 6 sites in Canada.
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 6 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: finished, as of the sponsor's last update on 16 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 6 sites in Canada. 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. 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 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?
Total Nasal Symptom Score (TNSS) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00537355, which also lists 1 linked publication.
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 16 Apr 2019.