Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ALK-Abelló A/S
With
Merck Sharp & Dohme LLC
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)
