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)

ALK-Abelló

Status and phase: Completed; Phase 2

Conditions: Rhinitis, Allergic, Nonseasonal; Rhinitis, Allergic, Perennial

Treatments: Drug: MK-8237 6 DU; Drug: Placebo; Drug: MK-8237 12 DU

Study type: Interventional

Funder types: Industry

Identifiers

NCT01644617

8237-003 (Other Identifier)

P07627

2012-001855-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

124 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks

Treatment:

Drug: Placebo

MK-8237 6 Developmental Units (DU)

Experimental group

Description:

MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks

Treatment:

Drug: MK-8237 6 DU

MK-8237 12 DU

Experimental group

Description:

MK-8237 12 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks

Treatment:

Drug: MK-8237 12 DU