Allergic RhinitisPhase 1NCT02557633
A Study of Tolerability and Safety of Two New Doses of Grass MATA MPL
A Phase 1 study testing Grass MATA MPL 10200 and Grass MATA MPL 18200 in people with Allergic Rhinitis, run by Allergy Therapeutics at 2 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
- Allergic Rhinitis
- What is being tested?
- Grass MATA MPL 10200 and Grass MATA MPL 18200
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2015to Oct 2016
- 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 radioallergosorbent or equivalent test with class ≥ 2
- History of at least 2 seasons of moderate to severe seasonal rhinoconjunctivitis due to an IgE - mediated allergy to pollen from grass
- Males or non-pregnant, non-lactating females who are:
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- Post-menopausal (defined as at least 12 months natural spontaneous amenorrhea or at least 6 weeks following surgical menopause, i.e. bilateral oophorectomy)
- Naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation)
- Of childbearing potential - with negative urinary and serological pregnancy test and use at least one of the following contraception methods:
- Stable hormonal contraceptive for ≥ 90 days prior to Visit 1 and at least 7 days after the final injection. If < 90 days prior to the study, additional use of a double barrier method until 90 days reached is required.
- Placement of an intrauterine device (IUD) or intrauterine system
- Use of barrier methods of contraception (e.g., condom or occlusive cap) with spermicidal foam/gel/film/cream /suppository
- Use of double barrier methods of contraception (e.g., male condom with diaphragm, male condom with cervical cap)
- Patients who are normally active and otherwise judged to be in good health
- Patients must be willing and able to attend required study visits.
- Patients must be able to follow instructions.
- Patients must be willing and able to give written informed consent and must provide this 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.
- Concurrent disease that might complicate or interfere with investigation or evaluation of the study medications or the skin prick test result, such as:
- Any ocular disorder (other than allergic conjunctivitis) including presumed infectious ocular disease (bacterial, fungal, viral, etc.), which could interfere with the evaluation of the study medication Rhinitis medicamentosa
- Documented evidence of acute or significant chronic sinusitis, upper or lower respiratory tract infection within 30 days before Visit 2 as determined by the Investigator
- Asthma, with the exception of mild intermittent asthma
- Emergency room visit or admission for asthma in the 12 months prior to Visit 1 or history of a life-threatening asthma attack ever
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- Presence of acute or subacute atopic dermatitis, chronic dermatitis, urticaria factitia, or urticaria due to physical/chemical influence
- Presence of emphysema or bronchiectasis
- Auto-immune disease, cancer, or concomitant illness that in the opinion of the Investigator would pose a safety risk or compromise the interpretation of study results
- Use of oral, intramuscular, intravenous corticosteroids, or potent or super-potent topical corticosteroids, from 30 days prior to screening up to Visit 8
- Presence of tattoos or other skin abnormalities in the upper arms which would prevent an accurate assessment of local skin reaction
- Allergy, hypersensitivity or intolerance to the excipients of the study medication
- Anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis
- Immunodeficiency, including those who are on immunosuppressant therapy
- Recurrent idiopathic angioedema
- Tyrosine metabolism disorders, especially tyrosinemia and alkaptonuria
- β-blocker (including eye drops), monoamine oxidase medication
- Unable to receive epinephrine therapy (i.e., use of epinephrine is contraindicated)
- Clinical history of drug or alcohol abuse, at the Investigator's discretion, that would interfere with the patient's participation in the study
- Any clinically significant abnormal laboratory value (as determined by the Investigator) at Visit 1
- Study site staff or immediate relatives of study site staff or other individuals who would have access to the clinical study protocol or people considered as vulnerable or institutionalized
- Have undergone specific immunotherapy with comparable allergen extracts. An exception will be allowed if prior immunotherapy with comparable allergen was successful, symptoms reappeared some-time after stopping the immunotherapy, and the immunotherapy was completed ≥ 3 years before Visit 1
- Treatment with a preparation containing MPL® within 6 months prior to Visit 1.
- Participation in a clinical research study with an investigational medicinal product within 4 weeks of Visit 1 or concomitantly with this study, including the safety follow-up period up to 12 months following the last injection.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Inflamax Research, Inc.
Neptune City, New Jersey, 07753
Inflamx Research
Newark, New Jersey, 07105
About this study
Official title: A Pre-season, Single Site, Single-blind, Parallel Group, Randomized Study to Determine the Tolerability and Safety of Two New Cumulative Doses of Modified Grass Allergens Adsorbed to L-tyrosine With Monophosphoryl Lipid A Adjuvant (Corixa), Phenol Preserved (Grass MATA MPL); Allergy Therapeutics, (UK) Ltd., 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.
Two new cumulative doses of the Grass MATA MPL 10200 and 18200 SU (Standardized Units) are being developed to compare with the current dose of 5100 SU. The purpose of this study is to evaluate the tolerability and safety of these two new cumulative dose regimens 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 go into a larger scale study to assess the efficacy and safety of the higher cumulative doses.
Read the detailed description
Structure: Single center, parallel group, single-blind, randomized study There will be three treatment groups, two groups receiving a different, cumulative dose of Grass MATA MPL and the third group receiving placebo only.
Duration: The duration of the study from screening to final visit after treatment is expected to be approximately 7 weeks. There will be a telephone follow up at 1, 3, 6 and 12 months after treatment.
- Conditions
- Allergic Rhinitis
- Being tested
- Grass MATA MPL 10200, Grass MATA MPL 18200, Placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grass MATA MPL 10200Biological
Grass MATA MPL 18200Biological
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 2% w/v L-Tyrosine Receives: Biological: Placebo |
| Grass MATA MPL 10200 SU | Experimental | Grass MATA MPL cumulative dose 10200 SU given as six injections of placebo, placebo, 600SU, 1600SU, 4000SU and 4000SU. Receives: Biological: Grass MATA MPL 10200 |
| Grass MATA MPL 18200 SU | Experimental | Grass MATA MPL cumulative dose 18200 SU given as six injections of 600SU, 1600SU, 4000SU, 4000SU, 4000SU and 4000SU. Receives: Biological: Grass MATA MPL 18200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of AEs
Aggregate of the number of AEs, adverse reaction complexes (ARCs; the total of treatment related injection site and systemic AEs experienced by a patient within a 24-hour period after an injection)
Measured: 8 weeks
Premature discontinuation
The frequency of premature discontinuation from treatment or study due to AEs between the treatment groups
Measured: 8 weeks
Secondary outcomes (1)
AEs of special interest
The number and frequency of neuro-inflammatory or new onset autoimmune disease.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2015
- Study completionOct 2016
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergy Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inflamax Research Incorporated, Metronomia Clinical Research GMBH
- Responsible party
- Sponsor
- Investigators
- Tim Higenbottam, DSc MD FRCP FFPM, Study director, Allergy Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557633
- Sponsor's protocol ID
- GrassMATAMPL102
- Status last verified
- Mar 2017
- First submitted
- 15 Sep 2015
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-season, Single Site, Single-blind, Parallel Group, Randomized Study to Determine the Tolerability and Safety of Two New Cumulative Doses of Modified Grass Allergens Adsorbed to L-tyrosine With Monophosphoryl Lipid A Adjuvant (Corixa), Phenol Preserved (Grass MATA MPL); Allergy Therapeutics, (UK) Ltd., Compared With Placebo in Patients With Seasonal Allergic Rhinoconjunctivitis Due to Grass Pollen Allergy.
- ClinicalTrials.gov ID
- NCT02557633
- Acronym / sponsor ID
- GrassMATAMPL102
- Conditions
- Allergic Rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Allergy TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Inflamax Research Incorporated, Metronomia Clinical Research GMBH
- Study start
- Aug 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 23 Sep 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.
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.
Two new cumulative doses of the Grass MATA MPL 10200 and 18200 SU (Standardized Units) are being developed to compare with the current dose of 5100 SU. The purpose of this study is to evaluate the tolerability and safety of these two new cumulative dose regimens 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 go into a larger scale study to assess the efficacy and safety of the higher cumulative doses.
Detailed description
Structure: Single center, parallel group, single-blind, randomized study There will be three treatment groups, two groups receiving a different, cumulative dose of Grass MATA MPL and the third group receiving placebo only.
Duration: The duration of the study from screening to final visit after treatment is expected to be approximately 7 weeks. There will be a telephone follow up at 1, 3, 6 and 12 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: Placebo2% w/v L-Tyrosine |
| Grass MATA MPL 10200 SU | Experimental | Biological: Grass MATA MPL 10200Grass MATA MPL cumulative dose 10200 SU given as six injections of placebo, placebo, 600SU, 1600SU, 4000SU and 4000SU. |
| Grass MATA MPL 18200 SU | Experimental | Biological: Grass MATA MPL 18200Grass MATA MPL cumulative dose 18200 SU given as six injections of 600SU, 1600SU, 4000SU, 4000SU, 4000SU and 4000SU. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 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 radioallergosorbent or equivalent test with class ≥ 2
- History of at least 2 seasons of moderate to severe seasonal rhinoconjunctivitis due to an IgE - mediated allergy to pollen from grass
Key exclusion criteria (24 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.
- Concurrent disease that might complicate or interfere with investigation or evaluation of the study medications or the skin prick test result, such as:
- Auto-immune disease, cancer, or concomitant illness that in the opinion of the Investigator would pose a safety risk or compromise the interpretation of study results
- Use of oral, intramuscular, intravenous corticosteroids, or potent or super-potent topical corticosteroids, from 30 days prior to screening up to Visit 8
- Presence of tattoos or other skin abnormalities in the upper arms which would prevent an accurate assessment of local skin reaction
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 |
|---|---|---|
| Grass MATA MPL 10200 | Biological | Grass MATA MPL 10200 SU |
| Grass MATA MPL 18200 | Biological | Grass MATA MPL 18200 SU |
| Placebo | Biological | Placebo |
Primary outcome
Number of AEs
Time frame: 8 weeks
Aggregate of the number of AEs, adverse reaction complexes (ARCs; the total of treatment related injection site and systemic AEs experienced by a patient within a 24-hour period after an injection)
Premature discontinuation
Time frame: 8 weeks
The frequency of premature discontinuation from treatment or study due to AEs between the treatment groups
1 secondary outcome
AEs of special interest
Time frame: one year
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 Mar 2017.
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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, DSc MD FRCP FFPM study director
Allergy Therapeutics
2 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 10200 and Grass MATA MPL 18200 in people with Allergic Rhinitis, run by Allergy Therapeutics 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 17 inclusion and 24 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 Mar 2017. 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. 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 of AEs (time frame: 8 weeks). The study lists 2 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 3 Mar 2017.