A Study of Tolerability and Safety of Two New Doses of Grass MATA MPL (NCT02557633) | Clinical Trial Compass
CompletedPhase 1
A Study of Tolerability and Safety of Two New Doses of Grass MATA MPL
United States29 participantsStarted 2015-08
Plain-language 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.
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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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:
* 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)
* Pa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.