Allergic Rhino-ConjunctivitisPhase 2NCT02271009
Compare Dose Regimens of AllerT, in Adults With Allergic Rhino-Conjunctivitis to Birch Pollen Studied in EEC
A Phase 2 study testing AllerT in people with Allergic Rhino-Conjunctivitis, run by Anergis at 1 site in Canada.
Trial summary
The purpose of this study is to find the optimal dose of AllerT that should be used to treat moderate to severe allergies due to birch tree pollen. There are 4 treatment groups in this study; 3 treatment groups will receive AllerT at different doses and 1 treatment group will receive placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhino-Conjunctivitis
- What is being tested?
- AllerT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to May 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum two-year history of moderate to severe rhino-conjunctivitis on exposure to birch pollen with a need to take symptomatic medications (antihistamine, steroid) during pollen season, prior to study enrollment.
- Sensitivity to birch tree pollen confirmed at Screening by both of the following criteria:
- Positive Skin Prick Test (SPT) to birch pollen extract (wheal ≥ 3 mm than the negative control). Negative control must be ≤ 2 mm.
- Positive specific IgE CAP test for Bet v 1 (≥ 0.7 kU/L).
- A qualifying score in at least one of the two Baseline EEC Challenges: at least one diary card of 12/24 or greater for Total Rhinoconjunctivitis Symptom Score (TRSS) as well as either one diary card 6/12 or greater for Total Nasal Symptom Score (TNSS) or Total Ocular Symptom Score (TOSS).
Who cannot join
- Positive SPT to AllerT (wheal ≥ 3 mm than the negative control).
- Received specific immunotherapy against:
- Any allergen within three years before the Screening visit.
- Birch tree pollen or a tree pollen mix including birch pollen at any time before the Screening visit.
- Clinically significant symptoms due to allergens other than birch pollen during the EEC challenge periods (eg, perennial allergies, allergies to other pollens with overlapping allergy seasons during the EEC periods).
- Persistent un-controlled asthma; subjects with a Forced Expiratory Volume (FEV1) lower than 80% of their predicted value and/or subjects under chronic treatment for asthma with regular use of inhaled steroids. Subjects with seasonal asthma may be included. Subjects who require the occasional use of inhaled broncho-dilator can be included.
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- History of birch pollen induced asthma. Note: A diagnosis of isolated exercise induced bronchospasm or controlled asthma (Global Initiative for Asthma [GINA] Step 1) not triggered by birch pollen does not constitute an exclusion criterion.
- History of documented severe anaphylactic reaction (Grade 4 of World Allergy Organization [WAO]).
- History of sinus disease including:
- Acute or significant chronic sinusitis.
- History of significant recurrent acute sinusitis, defined as two episodes per year for the last two years, all of which required antibiotic treatment.
- History of chronic sinusitis, defined as sinus symptoms lasting greater than 12 weeks that includes two or more major factors or one major factor and two minor factors. Major factors are defined as facial pain or pressure, nasal obstruction or blockage, nasal discharge or purulence or discolored postnasal discharge, purulence in nasal cavity, or impaired or loss of smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain, cough, and ear pain, pressure, or fullness.
- Subjects who cannot tolerate the Baseline EEC Challenge or do not meet the Baseline EEC Challenge inclusion criteria.
- Subjects with a history of immunodeficiency or any other conditions that might affect the subject's safety or interpretation of study results.
- Received immunosuppressive medication (including oral corticosteroids) within four weeks prior to Screening, or planned to be used during the trial period.
- Received systemic or local antihistamines, oral or inhaled corticosteroids or under antidepressant medication with antihistamine effects within two weeks prior to Screening.
- Subjects for whom administration of epinephrine is contraindicated (eg, subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
- Subjects being treated with beta-blockers in any form including topical ocular beta-blocker type medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized Trial to Compare the Efficacy and Tolerability of Three Dose Regimens of AllerT, in Adults With Allergic Rhino-Conjunctivitis to Birch Pollen Studied in Environmental Exposure Chamber
The purpose of this study is to find the optimal dose of AllerT that should be used to treat moderate to severe allergies due to birch tree pollen.
There are 4 treatment groups in this study; 3 treatment groups will receive AllerT at different doses and 1 treatment group will receive placebo.
This study will also assess the effectiveness and safety of AllerT compared to placebo in relieving allergy symptoms.
Read the detailed description
Primary Objective: To evaluate the dose-response trend of three doses of adjuvanted AllerT and of placebo in reducing symptoms of allergic rhino-conjunctivitis in subjects exposed to birch tree pollen in an environmental exposure chamber (EEC).
Secondary Objectives:
- To evaluate three dose regimens of AllerT , versus a placebo in reducing symptoms of allergic rhino-conjunctivitis in subjects exposed to birch tree pollen in an EEC.
- To assess the safety and tolerability of a two month treatment with three dose regiments of AllerT (10 µg, 25 µg and 50 µg with Al(OH)3).
- To explore the immunological response to AllerT.
- Conditions
- Allergic Rhino-Conjunctivitis
- Being tested
- AllerT, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllerTDrug
Also called Continuous overlapping peptides
Ultrafast immunotherapy
PlaceboDrug
placebo control
| Study group | Role | What they receive |
|---|---|---|
| Placebo without Al(OH)3 | Placebo comparator | Five (5) SC injections over a two-month (8-week) period, according to the following schedule:
* First three SC injections at weekly intervals.
* Fourth SC injection two weeks after the third injection.
* Fifth SC injection four weeks after the fourth injection. Receives: Drug: Placebo |
| AllerT (10 µg with Al(OH)3) | Active comparator | Five (5) SC injections over a two-month (8-week) period, according to the following schedule:
* First three SC injections at weekly intervals.
* Fourth SC injection two weeks after the third injection.
* Fifth SC injection four weeks after the fourth injection. Receives: Drug: AllerT |
| AllerT (25 µg with Al(OH)3) | Active comparator | Five (5) SC injections over a two-month (8-week) period, according to the following schedule:
* First three SC injections at weekly intervals.
* Fourth SC injection two weeks after the third injection.
* Fifth SC injection four weeks after the fourth injection. Receives: Drug: AllerT |
| AllerT (50 µg with Al(OH)3) | Active comparator | Five (5) SC injections over a two-month (8-week) period, according to the following schedule:
* First three SC injections at weekly intervals.
* Fourth SC injection two weeks after the third injection.
* Fifth SC injection four weeks after the fourth injection. Receives: Drug: AllerT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in average Total Rhinoconjunctivitis Symptom Scores (TRSS) from the Baseline EEC Challenge (Visit 1 & Visit 2) to the Post-Treatment EEC Challenge (PTC) (Visit 8 & Visit 9).
The mean TRSS will be calculated for each subject from t =1 hour to t = 6 hours inclusive for the 2 consecutive days (22 time points) of Baseline and post-treatment EEC challenge.
Measured: before entry in the EEC (time point = 0) and then every 30 minutes up to 6 hours in the EEC (12 time points)
Secondary outcomes (9)
Individual Nasal Symptom Scores (NSS)
- The change in the average of individual NSS from the Baseline EEC Challenge (Visit 1 \& Visit 2) to the Post-Treatment EEC Challenge (Visit 8 \& Visit 9).
Measured: from t =1 hour to t = 6 hours inclusive for the 2 consecutive days (22 time points) of Baseline and post-treatment EEC challenge
Individual NSS
Individual NSS from Baseline EEC Challenge (Visit 1 \& Visit 2) to Post-Treatment EEC Challenge (Visit 8 \& Visit 9) (24 time points).
Measured: All time points in the EEC for the 2 consecutive days (24 time points) of Baseline and post-treatment EEC challenge
The Global Evaluation of Treatment Efficacy Questionnaire
Measured: Visit 9, after the last post-treatment EEC session.
The Asthma Symptom Score (ASS)
The mean ASS will be calculated for each subject from t =1 hour to t = 6 hours inclusive for the 2 consecutive days of the EEC challenge (22 time points). The following will be analyzed:
- The change in the average ASS from the Baseline EEC Challenge (Visit 1 \& Visit 2) to the Post-Treatment EEC Challenge (Visit 8 \& Visit 9).
- The change in the pre-EEC-Specific Quality of Life Questionnaire (EEC-Specific QoLQ) to post EEC-QoLQ will be calculated at Baseline EEC Challenge (Visit 1 \& Visit 2) and at Post-Treatment EEC Challenge (PTC) (Visit 8 \& Visit 9). Change of (post- pre-EEC) form Baseline to PTC will be compared between treatment groups.
Measured: before entry in the EEC (time point =0) and then every 30 minutes up to 6 hours in the EEC (12 time points)
The mean TRSS
The following will be analyzed:
- The change in the average TRSS, from Baseline EEC Challenge (Visit 1 \& Visit 2) to Post-Treatment EEC Challenge (Visit 8 \& Visit 9) (24 time points).
- The change in the average TRSS from the Baseline EEC Challenge (Visit 1, 12 time points) to the Post-Treatment EEC Challenge (Visit 8, 12 time points) will be calculated.
Measured: All time points in the EEC for the 2 consecutive days (24 time points) of Baseline and post-treatment EEC challenge
The mean TNSS
The following will be analyzed:
- The change in the average TNSS from Baseline EEC Challenge (Visit 1 \& Visit 2) to Post-Treatment EEC Challenge (Visit 8 \& Visit 9) (24 time points).
- The change in the average TNSS from the Baseline EEC Challenge (Visit 1, 12 time points) to the Post-Treatment EEC Challenge (Visit 8, 12 time points) will be calculated.
Measured: All time points in the EEC for the 2 consecutive days (24 time points) of Baseline and post-treatment EEC challenge
The mean TOSS
The following will be analyzed:
- The change in the average TOSS from Baseline EEC Challenge (Visit 1 \& Visit 2) to Post-Treatment EEC Challenge (Visit 8 \& Visit 9) (24 time points).
- The change in the average TOSS from the Baseline EEC Challenge (Visit 1, 12 time points) to the Post-Treatment EEC Challenge (Visit 8, 12 time points) will be calculated.
Measured: All time points in the EEC for the 2 consecutive days (24 time points) of Baseline and post-treatment EEC challenge
The mean Total Nasal Symptom Scores (TNSS)
The following will be analyzed:
- The change in the average TNSS from the Baseline EEC Challenge (Visit 1 \& Visit 2) to the Post-Treatment EEC Challenge (Visit 8 \& Visit 9).
Measured: from t =1 hour to t = 6 hours inclusive for the 2 consecutive days (22 time points) of Baseline and post-treatment EEC challenge
Total Ocular Symptom Score (TOSS)
- The changes in the average TOSS from the Baseline EEC Challenge (Visit 1 \& Visit 2) to the Post-Treatment EEC Challenge (Visit 8 \& Visit 9).
Measured: before entry in the EEC (time point = 0) and then every 30 minutes up to 6 hours in the EEC (12 time points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhino-ConjunctivitisStudies 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, Care provider, Investigator
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anergis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inflamax Research Incorporated
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271009
- Sponsor's protocol ID
- AN008T
- Status last verified
- Dec 2015
- First submitted
- 14 Oct 2014
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized Trial to Compare the Efficacy and Tolerability of Three Dose Regimens of AllerT, in Adults With Allergic Rhino-Conjunctivitis to Birch Pollen Studied in Environmental Exposure Chamber
- ClinicalTrials.gov ID
- NCT02271009
- Acronym / sponsor ID
- AN008T
- Conditions
- Allergic Rhino-Conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- AnergisIndustry (pharma, biotech, devices)
- Collaborators
- Inflamax Research Incorporated
- Study start
- Oct 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 22 Oct 2014 (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 find the optimal dose of AllerT that should be used to treat moderate to severe allergies due to birch tree pollen.
There are 4 treatment groups in this study; 3 treatment groups will receive AllerT at different doses and 1 treatment group will receive placebo.
This study will also assess the effectiveness and safety of AllerT compared to placebo in relieving allergy symptoms.
Detailed description
Primary Objective: To evaluate the dose-response trend of three doses of adjuvanted AllerT and of placebo in reducing symptoms of allergic rhino-conjunctivitis in subjects exposed to birch tree pollen in an environmental exposure chamber (EEC).
Secondary Objectives:
- To evaluate three dose regimens of AllerT , versus a placebo in reducing symptoms of allergic rhino-conjunctivitis in subjects exposed to birch tree pollen in an EEC.
- To assess the safety and tolerability of a two month treatment with three dose regiments of AllerT (10 µg, 25 µg and 50 µg with Al(OH)3).
- To explore the immunological response to AllerT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo without Al(OH)3 | Placebo comparator | Drug: PlaceboFive (5) SC injections over a two-month (8-week) period, according to the following schedule: * First three SC injections at weekly intervals. * Fourth SC injection two weeks after the third injection. * Fifth SC injection four weeks after the fourth injection. |
| AllerT (10 µg with Al(OH)3) | Active comparator | Drug: AllerTFive (5) SC injections over a two-month (8-week) period, according to the following schedule: * First three SC injections at weekly intervals. * Fourth SC injection two weeks after the third injection. * Fifth SC injection four weeks after the fourth injection. |
| AllerT (25 µg with Al(OH)3) | Active comparator | Drug: AllerTFive (5) SC injections over a two-month (8-week) period, according to the following schedule: * First three SC injections at weekly intervals. * Fourth SC injection two weeks after the third injection. * Fifth SC injection four weeks after the fourth injection. |
| AllerT (50 µg with Al(OH)3) | Active comparator | Drug: AllerTFive (5) SC injections over a two-month (8-week) period, according to the following schedule: * First three SC injections at weekly intervals. * Fourth SC injection two weeks after the third injection. * Fifth SC injection four weeks after the fourth injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Minimum two-year history of moderate to severe rhino-conjunctivitis on exposure to birch pollen with a need to take symptomatic medications (antihistamine, steroid) during pollen season, prior to study enrollment.
- Sensitivity to birch tree pollen confirmed at Screening by both of the following criteria:
- Positive Skin Prick Test (SPT) to birch pollen extract (wheal ≥ 3 mm than the negative control). Negative control must be ≤ 2 mm.
- Positive specific IgE CAP test for Bet v 1 (≥ 0.7 kU/L).
- A qualifying score in at least one of the two Baseline EEC Challenges: at least one diary card of 12/24 or greater for Total Rhinoconjunctivitis Symptom Score (TRSS) as well as either one diary card 6/12 or greater for Total Nasal Symptom Score (TNSS) or Total Ocular Symptom Score (TOSS).
Key exclusion criteria (18 listed)
- Positive SPT to AllerT (wheal ≥ 3 mm than the negative control).
- Received specific immunotherapy against:
- Clinically significant symptoms due to allergens other than birch pollen during the EEC challenge periods (eg, perennial allergies, allergies to other pollens with overlapping allergy seasons during the EEC periods).
- Persistent un-controlled asthma; subjects with a Forced Expiratory Volume (FEV1) lower than 80% of their predicted value and/or subjects under chronic treatment for asthma with regular use of inhaled steroids. Subjects with seasonal asthma may be included. Subjects who require the occasional use of inhaled broncho-dilator can be included.
- History of birch pollen induced asthma. Note: A diagnosis of isolated exercise induced bronchospasm or controlled asthma (Global Initiative for Asthma [GINA] Step 1) not triggered by birch pollen does not constitute an exclusion criterion.
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 |
|---|---|---|
| AllerTAlso: Continuous overlapping peptidesUltrafast immunotherapy | Drug | AllerT (10 µg with Al(OH)3), AllerT (25 µg with Al(OH)3), AllerT (50 µg with Al(OH)3) |
| Placeboplacebo control | Drug | Placebo without Al(OH)3 |
Primary outcome
The change in average Total Rhinoconjunctivitis Symptom Scores (TRSS) from the Baseline EEC Challenge (Visit 1 & Visit 2) to the Post-Treatment EEC Challenge (PTC) (Visit 8 & Visit 9).
Time frame: before entry in the EEC (time point = 0) and then every 30 minutes up to 6 hours in the EEC (12 time points)
The mean TRSS will be calculated for each subject from t =1 hour to t = 6 hours inclusive for the 2 consecutive days (22 time points) of Baseline and post-treatment EEC challenge.
9 secondary outcomes
Individual Nasal Symptom Scores (NSS)
Time frame: from t =1 hour to t = 6 hours inclusive for the 2 consecutive days (22 time points) of Baseline and post-treatment EEC challenge
Individual NSS
Time frame: All time points in the EEC for the 2 consecutive days (24 time points) of Baseline and post-treatment EEC challenge
The Global Evaluation of Treatment Efficacy Questionnaire
Time frame: Visit 9, after the last post-treatment EEC session.
The Asthma Symptom Score (ASS)
Time frame: before entry in the EEC (time point =0) and then every 30 minutes up to 6 hours in the EEC (12 time points)
The mean TRSS
Time frame: All time points in the EEC for the 2 consecutive days (24 time points) of Baseline and post-treatment EEC challenge
The mean TNSS
Time frame: All time points in the EEC for the 2 consecutive days (24 time points) of Baseline and post-treatment EEC challenge
The mean TOSS
Time frame: All time points in the EEC for the 2 consecutive days (24 time points) of Baseline and post-treatment EEC challenge
The mean Total Nasal Symptom Scores (TNSS)
Time frame: from t =1 hour to t = 6 hours inclusive for the 2 consecutive days (22 time points) of Baseline and post-treatment EEC challenge
Total Ocular Symptom Score (TOSS)
Time frame: before entry in the EEC (time point = 0) and then every 30 minutes up to 6 hours in the EEC (12 time points)
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 3 Dec 2015.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AllerT in people with Allergic Rhino-Conjunctivitis, run by Anergis at 1 site 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 5 inclusion and 18 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 3 Dec 2015. 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 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?
The change in average Total Rhinoconjunctivitis Symptom Scores (TRSS) from the Baseline EEC Challenge (Visit 1 & Visit 2) to the Post-Treatment EEC Challenge (PTC) (Visit 8 & Visit 9). (time frame: before entry in the EEC (time point = 0) and then every 30 minutes up to 6 hours in the EEC (12 time points)). 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 3 Dec 2015.