CompletedPhase 3

A Study of SCH 697243 in Participants With Grass Pollen Allergy Symptoms, With or Without Asthma (P08067)

1,501 participantsStarted 2011-06

Plain-language summary

This is a study to evaluate the efficacy and safety of grass sublingual tablet (SCH 697243) versus placebo in the treatment of grass pollen-induced allergic hayfever symptoms. Participants will receive either the sublingual grass tablet or a placebo tablet during the study. It is expected that those participants receiving the active sublingual grass tablet will have less hayfever symptoms and need less medications to treat hayfever symptoms during the grass pollen season.

Who can participate

Age range

5 Years – 65 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: * Must have a clinical history of significant allergic rhinoconjunctivitis to grass (with or without asthma) * Must have a positive skin prick test response to Phleum pratense (Timothy grass) * Must be positive for specific immunoglobulin E (IgE) against Phleum pratense (Timothy grass) * Must have an forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at Screening \- Safety laboratory tests and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor Exclusion Criteria: * Has a clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to another allergen during or potentially overlapping the GPS * Has a clinical history of significant symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the participant is regularly exposed * Has received an immunosuppressive treatment within 3 months prior to the Screening Visit * Has a clinical history of severe asthma * Has a history of anaphylaxis with cardiorespiratory symptoms * Has a history of self-injectable epinephrine use * Has a history of chronic urticaria and angioedema * Has a clinical history of chronic sinusitis during the 2 years prior to the Screening Visit * Has current severe atopic dermatitis * Is breast-feeding, pregnant, or intending to become pregnant * Had previous treatment by immunotherapy with any grass pollen allergen for more than 1 month within…

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.

What they're measuring

Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS)

Timeframe: Entire GPS (expected average duration of 5 to 6 weeks)

Trial details

NCT IDNCT01385371

SponsorALK-Abelló A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-08

Results submitted2013-07-01

View on ClinicalTrials.gov More Rhinitis Allergic trials