CompletedPhase 3

Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)

1,482 participantsStarted 2013-01

Plain-language summary

The purpose of this study is to assess the efficacy and safety of MK-8237 (SCH 900237) in the treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis (AR/ARC) in children and adults. The primary hypothesis of this study is that administration of MK-8237, compared to placebo, results in significant reduction in the average total combined rhinitis score (TCRS).

Who can participate

Age range

12 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: * History of AR/ARC to house dust of 1 year duration or more (with or without asthma) * If female of childbearing potential, has a negative urine pregnancy test at Screening and agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the study * Able to read, understand and complete questionnaires and diaries Exclusion Criteria: * Clinically relevant history of symptomatic ARC caused by animal dander, molds and/or cockroach (e.g. present in the home, job, daycare, etc.) or other perennial allergen * History of symptomatic seasonal ARC and/or asthma due to an allergen to which the participant is sensitized and regularly exposed * Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyposis) * Received an immunosuppressive treatment within 3 months prior to screening * Unstable or severe asthma, or has experienced a life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids (but allowing short-acting beta agonists \[SABAs\]) at any time within 3 months prior to screening * Asthma requiring high-dose inhaled corticosteroids (ICS) within 6 months prior to screening * History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause or inhalant allergen * History of chronic urticaria…

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 Rhinitis Score (TCRS) During Last 8 Weeks of Treatment

Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)

Number of Participants Who Experience At Least One Adverse Event (AE)

Timeframe: Up to 54 weeks

Number of Participants Who Discontinue Study Drug Due to an AE

Timeframe: Up to 52 weeks

Trial details

NCT IDNCT01700192

SponsorALK-Abelló A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-04

Results submitted2017-01-11

View on ClinicalTrials.gov More Rhinitis, Allergic, Perennial trials