A Dose-Ranging Study of the Safety and Effectiveness of MK-8237 in the Treatment of House Dust Mite (HDM) Induced Allergic Rhinitis/Rhinoconjunctivitis in Adults (MK-8237-003/P07627)

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the dose-related effectiveness, the safety and the tolerability of MK-8237, compared to placebo, in the treatment of house dust mite (HDM)-induced allergic rhinitis/rhinoconjunctivitis in adults. The primary hypothesis is that administration of MK-8237, compared to placebo, results in dose-related improvement in the average total nasal symptom score (TNSS) determined during environmental exposure chamber (EEC) challenge.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ALK-Abelló A/S; Merck Sharp & Dohme Corp.
• Collaborator: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• History of allergic rhinitis/rhinoconjunctivitis 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) 2 acceptable methods of birth control within the projected duration of the study.

Exclusion Criteria:

• Sensitized and regularly exposed to animal dander and molds, (e.g. present in the home, job, etc.)

• Sensitized and regularly exposed to seasonal allergens (i.e., birch or grass pollen)

• Immunosuppressive treatment within 3 months prior to screening (except steroids for allergic and asthma symptoms)

• History of chronic urticaria and/or angioedema within 2 years prior to screening

• Previous immunotherapy treatment with any HDM allergen for more than 1 month within 3 years prior to screening

• Ongoing treatment with any specific immunotherapy

• History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, due to an unknown cause or to an inhalant allergen

• Unstable uncontrolled/partially controlled or severe asthma, or 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 [SABA]) within 3 months prior to screening

• Asthma requiring medium- or high-dose inhaled corticosteroid (ICS) within 12 months prior to screening

• Chronic sinusitis within 2 years prior to screening

• Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyps)

• Pregnant, breastfeeding or planning to become pregnant during the study

• Participation in a different investigational study at any site during the same time frame of this study

• Direct association with the administration of the study or a family member of the study staff