Seasonal Allergic RhinitisPhase 1G104NCT03931993
A Study of Tolerability and Safety of a New Cumulative Dose of Grass MATA MPL
A Phase 1 study testing Grass MATA MPL in people with Seasonal Allergic Rhinitis, run by Allergy Therapeutics at 4 sites in United States.
Trial summary
There is increasing evidence that the effectiveness of allergy immunotherapy to control symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid administered during a single regimen of subcutaneous (SC) injections or of sublingual administration. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Grass MATA MPL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Jan 2017to 27 Apr 2017
- Phase
- Phase 1
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must have a positive skin prick test for grass pollen allergen.
- Positive skin prick test to positive histamine control
- Negative skin prick test to negative control
- Specific IgE for grass pollen as documented by ImmunoCAP test with class ≥ 2
- A history of moderate to severe symptoms of seasonal allergic rhinitis and/or conjunctivitis due to grass (Pooideae) pollen exposure that required repeated use of antihistamines, nasal steroids, and/or leukotriene modifiers for relief of symptoms during the last two consecutive seasons prior to the study
- Males or non-pregnant, non-lactating females who are not of child-bearing potential or using effective contraception
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- Patients who are normally active and otherwise judged to be in good health
- For patients with a history of asthma, forced expiratory volume in 1 second (FEV1) ≥ 80% of National Health and Nutrition Examination Surveys (NHANES) predicted, with a FEV1/forced vital capacity (FVC) ratio ≥ 70%.
- Able to observe the drug washout times listed in the Prohibited Medications Table below prior to screening
- Patients willing and able to attend required study visits and able to follow the protocol requirements.
- Patients willing and able to give written informed consent.
Who cannot join
- Symptoms outside the grass pollen season due to a perennial and/or non-grass seasonal allergen, if the patient is unable to avoid the offending allergen.
- Immunological disorders or other diseases that in the opinion of the investigator may pose a safety risk.
- Presence of moderate to severe asthma, characterized by the current use of inhaled steroids at a daily dose above 400 micrograms of budesonide (or equivalent)
- Emergency room visit or admission for asthma in the 12 months prior to Visit 1 or history of a life-threatening asthma attack ever.
- Presence of non-atopic rhinitis and/or rhino-sinusitis (with or without polyps).
- Presence of any skin conditions (skin abnormalities, tattoos etc.) which might interfere with the interpretation of the SPT results.
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- Current diagnosis of type I diabetes. Patients with type II diabetes will only be allowed to participate at the discretion of the investigator.
- Treatment with a preparation containing MPL (e.g. Cervarix) within 6 months prior to screening
- Moderate to severe upper or lower respiratory tract infections requiring medication within 14 days of or a diagnosis of sinusitis within 30 days of randomisation
- Clinical history of severe or life-threatening anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis.
- Clinical history of allergy, hypersensitivity or intolerance to the excipients of the study medication.
- Tyrosine metabolism disorders, especially tyrosinemia and alkaptonuria.
- Unable to receive epinephrine therapy (i.e., use of epinephrine is contraindicated).
- Clinical history of immunodeficiency, including those who are on immunosuppressant therapy.
- Clinical history of recurrent idiopathic angioedema.
- Beta-blocker medication, including eye drops, for any indication.
- Treatment with monoamine oxidase inhibitors, tricyclic antidepressants or ACE inhibitors.
- Clinical history of drug or alcohol abuse which, in the investigator's opinion, could interfere with the patient's ability to participate in the study.
- Participation in a clinical research trial with any investigational medicinal product within 4 weeks of screening or concomitantly with this study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Vedas Research
Edison, New Jersey
Atlantic Reseach Center
Ocean City, New Jersey, 07712
STARx Asthma and Allergy Center
Springfield, New Jersey, 07081-2515
Allergy Partners of New Jersey
Teaneck, New Jersey
About this study
Official title: A Pre-Season,Randomized,Single-blind,Placebo-controlled,Parallel-group Study to Determine Tolerability+Safety of a New Cumulative Dose of GrassMATAMPL Compared With Placebo in Patients With Seasonal Allergic Rhinoconjunctivitis Due to Grass Pollen Allergy
There is increasing evidence that the effectiveness of allergy immunotherapy to control symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid administered during a single regimen of subcutaneous (SC) injections or of sublingual administration. Previously, high cumulative doses of the Grass MATA MPL 10200 and 18200 SU (Standardized Units) were compared with the marketed dose of 5100 SU and were found to have acceptable tolerability and safety. The purpose of this study is to evaluate the tolerability and safety of an even higher cumulative dose regimen of 35600 SU. of Grass MATA MPL compared with placebo in patients with seasonal allergic rhinoconjunctivitis (SAR) due to grass pollen, to enable selection of the best dose to take forward for further development.
Read the detailed description
This will be a placebo-controlled study, using a 1:1 randomization and parallel-group, single-blind design, in patients with seasonal allergic rhino-conjunctivitis to grass pollen conducted at multiple centres in the US. The study will be conducted outside the grass pollen season and is comprised of 3 periods.
- Period 1: Screening
- Period 2: Randomization and treatment
- Period 3: Post-treatment safety follow-up
Period 1 consists of the screening visit (Visit 1) at which patient eligibility will be assessed. Blood samples will be taken for clinical safety laboratory assessments and for baseline transcriptomics analysis. Eligible patients will proceed to Period 2 for enrolment into study.
Period 2 starts with the randomization visit (Visit 2: 3-33 days after Visit 1), at which eligible patients will be randomly allocated to the Grass MATA MPL 35600 SU or placebo treatment groups and receive the first of 6 weekly injections of subcutaneous immunotherapy (SCIT). Injections 2 to 6 will be administered at Visits 3 to 7. After each injection, patients will be kept under observation at the site for at least 30 minutes by personnel qualified to observe for and manage local and systemic adverse events. This period may be extended by the investigator according to his/her judgment. The observation will be followed up by a telephone call approximately 24 hours after the time of injection. In the event of mild or moderate systemic adverse events judged by the investigator to be well-tolerated by the patient and to show good recovery, the patient may continue treatment as scheduled.
Period 3 (Visit 8 - End of Study) will occur 6-8 days after Visit 7 to review any AEs and to perform end-of-treatment assessments, which will include blood draws for safety laboratory tests and transcriptomics analysis.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Placebo comparator, Grass MATA MPL
- Keywords
- Grass MATA MPL, Safety
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo comparatorBiological
Grass MATA MPLBiological
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Placebo comparator | Six 1.0mL placebo injections (2% w/v L-tyrosine) Receives: Biological: Placebo comparator |
| Treatment Group 2 | Experimental | Six 1.0mL injections of Grass MATA MPL 900, 2700, 8000, 8000, 8000, and 8000 SU Receives: Biological: Grass MATA MPL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and frequency of adverse events (AEs)
Measured: 36 - 48 days
Number and frequency of adverse reaction complexes (ARCs)
The maximum intensity of all injection site [local] and systemic AEs experienced by a patient within a 24-hour period after an injection.
Measured: 36 - 48 days
Frequency of premature discontinuation from treatment or study due to AEs.
Measured: 36 - 48 days
Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Systolic blood pressure
Mean values compared to normal range
Measured: 30 - 40 days
Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Diastolic blood pressure
Mean values compared to normal range
Measured: 30 - 40 days
Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Pulse
Mean values compared to normal range
Measured: 30 - 40 days
Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Body temperature
Mean values compared to normal range
Measured: 30 - 40 days
Changes in routine clinical laboratory values - Serum Chemistry
Absolute and relative number of patients with values below, within or above the normal range
Measured: 36 - 48 days
Changes in routine clinical laboratory values - Hematology
Absolute and relative number of patients with values below, within or above the normal range
Measured: 36 - 48 days
Changes in routine clinical laboratory values - Urinalysis
Absolute and relative number of patients with values below, within or above the normal range
Measured: 36 - 48 days
Changes in peak expiratory flow rate (PEFR) before and after injections in asthmatic patients
Measured: 30 - 40 days
Secondary outcomes (2)
Number and frequency of neuro-inflammatory (NI) events.
Assessed by clinical judgement
Measured: 36 - 48 days
Number and frequency of new onset autoimmune disease (NOAD) events.
Assessed by clinical judgement
Measured: 36 - 48 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start16 Jan 2017
- Primary completion27 Apr 2017
- Study completion27 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergy Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SynteractHCR, Metronomia Clinical Research GMBH
- Responsible party
- Sponsor
- Investigators
- Tim Higenbottam, MD, FRCP, Study director, Allergy Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931993
- Sponsor's protocol ID
- GrassMATAMPL104
- Acronym
- G104
- Status last verified
- Apr 2019
- First submitted
- 29 Mar 2017
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-Season,Randomized,Single-blind,Placebo-controlled,Parallel-group Study to Determine Tolerability+Safety of a New Cumulative Dose of GrassMATAMPL Compared With Placebo in Patients With Seasonal Allergic Rhinoconjunctivitis Due to Grass Pollen Allergy
- ClinicalTrials.gov ID
- NCT03931993
- Acronym / sponsor ID
- G104 / GrassMATAMPL104
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Grass MATA MPL, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Allergy TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- SynteractHCR, Metronomia Clinical Research GMBH
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 27 Apr 2017 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 30 Apr 2019 (actual)
- 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.
There is increasing evidence that the effectiveness of allergy immunotherapy to control symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid administered during a single regimen of subcutaneous (SC) injections or of sublingual administration. Previously, high cumulative doses of the Grass MATA MPL 10200 and 18200 SU (Standardized Units) were compared with the marketed dose of 5100 SU and were found to have acceptable tolerability and safety. The purpose of this study is to evaluate the tolerability and safety of an even higher cumulative dose regimen of 35600 SU. of Grass MATA MPL compared with placebo in patients with seasonal allergic rhinoconjunctivitis (SAR) due to grass pollen, to enable selection of the best dose to take forward for further development.
Detailed description
This will be a placebo-controlled study, using a 1:1 randomization and parallel-group, single-blind design, in patients with seasonal allergic rhino-conjunctivitis to grass pollen conducted at multiple centres in the US. The study will be conducted outside the grass pollen season and is comprised of 3 periods.
- Period 1: Screening
- Period 2: Randomization and treatment
- Period 3: Post-treatment safety follow-up
Period 1 consists of the screening visit (Visit 1) at which patient eligibility will be assessed. Blood samples will be taken for clinical safety laboratory assessments and for baseline transcriptomics analysis. Eligible patients will proceed to Period 2 for enrolment into study.
Period 2 starts with the randomization visit (Visit 2: 3-33 days after Visit 1), at which eligible patients will be randomly allocated to the Grass MATA MPL 35600 SU or placebo treatment groups and receive the first of 6 weekly injections of subcutaneous immunotherapy (SCIT). Injections 2 to 6 will be administered at Visits 3 to 7. After each injection, patients will be kept under observation at the site for at least 30 minutes by personnel qualified to observe for and manage local and systemic adverse events. This period may be extended by the investigator according to his/her judgment. The observation will be followed up by a telephone call approximately 24 hours after the time of injection. In the event of mild or moderate systemic adverse events judged by the investigator to be well-tolerated by the patient and to show good recovery, the patient may continue treatment as scheduled.
Period 3 (Visit 8 - End of Study) will occur 6-8 days after Visit 7 to review any AEs and to perform end-of-treatment assessments, which will include blood draws for safety laboratory tests and transcriptomics analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blind
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Placebo comparator | Biological: Placebo comparatorSix 1.0mL placebo injections (2% w/v L-tyrosine) |
| Treatment Group 2 | Experimental | Biological: Grass MATA MPLSix 1.0mL injections of Grass MATA MPL 900, 2700, 8000, 8000, 8000, and 8000 SU |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Patients must have a positive skin prick test for grass pollen allergen.
- Positive skin prick test to positive histamine control
- Negative skin prick test to negative control
- Specific IgE for grass pollen as documented by ImmunoCAP test with class ≥ 2
- A history of moderate to severe symptoms of seasonal allergic rhinitis and/or conjunctivitis due to grass (Pooideae) pollen exposure that required repeated use of antihistamines, nasal steroids, and/or leukotriene modifiers for relief of symptoms during the last two consecutive seasons prior to the study
Key exclusion criteria (19 listed)
- Symptoms outside the grass pollen season due to a perennial and/or non-grass seasonal allergen, if the patient is unable to avoid the offending allergen.
- Immunological disorders or other diseases that in the opinion of the investigator may pose a safety risk.
- Presence of moderate to severe asthma, characterized by the current use of inhaled steroids at a daily dose above 400 micrograms of budesonide (or equivalent)
- Emergency room visit or admission for asthma in the 12 months prior to Visit 1 or history of a life-threatening asthma attack ever.
- Presence of non-atopic rhinitis and/or rhino-sinusitis (with or without polyps).
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 |
|---|---|---|
| Placebo comparator | Biological | Treatment Group 1 |
| Grass MATA MPL | Biological | Treatment Group 2 |
Primary outcome
Number and frequency of adverse events (AEs)
Time frame: 36 - 48 days
Number and frequency of adverse reaction complexes (ARCs)
Time frame: 36 - 48 days
The maximum intensity of all injection site [local] and systemic AEs experienced by a patient within a 24-hour period after an injection.
Frequency of premature discontinuation from treatment or study due to AEs.
Time frame: 36 - 48 days
Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Systolic blood pressure
Time frame: 30 - 40 days
Mean values compared to normal range
Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Diastolic blood pressure
Time frame: 30 - 40 days
Mean values compared to normal range
Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Pulse
Time frame: 30 - 40 days
Mean values compared to normal range
Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Body temperature
Time frame: 30 - 40 days
Mean values compared to normal range
Changes in routine clinical laboratory values - Serum Chemistry
Time frame: 36 - 48 days
Absolute and relative number of patients with values below, within or above the normal range
Changes in routine clinical laboratory values - Hematology
Time frame: 36 - 48 days
Absolute and relative number of patients with values below, within or above the normal range
Changes in routine clinical laboratory values - Urinalysis
Time frame: 36 - 48 days
Absolute and relative number of patients with values below, within or above the normal range
Changes in peak expiratory flow rate (PEFR) before and after injections in asthmatic patients
Time frame: 30 - 40 days
2 secondary outcomes
Number and frequency of neuro-inflammatory (NI) events.
Time frame: 36 - 48 days
Number and frequency of new onset autoimmune disease (NOAD) events.
Time frame: 36 - 48 days
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 30 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Tim Higenbottam, MD, FRCP study director
Allergy Therapeutics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Grass MATA MPL in people with Seasonal Allergic Rhinitis, run by Allergy Therapeutics at 4 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 11 inclusion and 19 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 30 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 4 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number and frequency of adverse events (AEs) (time frame: 36 - 48 days). The study lists 11 primary outcomes in all. 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 30 Apr 2019.