Rhinitis, Allergic, Perennial | Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)
Rhinitis, Allergic, Perennial research study
What is the primary objective of this study?
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 is eligible to participate?
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 and/or angioedema within 2 years prior to screening - History of chronic sinusitis during 2 years prior to screening - Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study - Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening - Previous exposure to MK-8237 - Receiving ongoing treatment with any specific immunotherapy at screening - Known history of allergy, hypersensitivity or intolerance to investigational medicinal products (except for D. pteronyssinus and/or D. farinae), rescue medications or self-injectable epinephrine - Unable to meet medication washout requirements prior to screening - Unable or unwilling to comply with the use of self-injectable epinephrine - Business or personal relationship with investigational site personnel or Sponsor who is directly involved with the conduct of the study - Likely to travel for extended periods of time during the efficacy assessment period - Participating in a different investigational study at any site during this study
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Nonseasonal
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Biological:MK-8237 tabletsMK-8237 12 DU rapidly dissolving tablets administered sublingually q.d.
Biological:Placebo tabletsPlacebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.
Drug:Rescue Medication: Self-Injectable EpinephrineSelf-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.
Drug:Rescue Medication: Loratadine tabletsLoratadine tablet 10 mg administered orally as needed for rescue medication.
Drug:Rescue Medication: Olopatadine ophthalmic dropsOlopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.
Drug:Rescue Medication: Mometasone furoate nasal sprayMometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
MK-8237MK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily (q.d.).
PlaceboPlacebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.
Start Date: January 2013
Completed Date: April 2015
Phase: Phase 3
Primary Outcome: Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment
Secondary Outcome: Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment
Study sponsors, principal investigator, and references
Principal Investigator: Medical Director
Lead Sponsor: ALK-Abelló A/S
Nolte H, Bernstein DI, Nelson HS, Kleine-Tebbe J, Sussman GL, Seitzberg D, Rehm D, Kaur A, Li Z, Lu S. Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2016 Dec;138(6):1631-1638. doi: 10.1016/j.jaci.2016.06.044. Epub 2016 Aug 10.