A Phase IIb, Randomized, Placebo-Controlled, Dose-Finding Clinical Trial to Study the Safety and Efficacy of MK-8237 Using an Environmental Exposure Chamber in Subjects With House Dust Induced Allergic Rhinitis/Rhinoconjunctivitis
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Rhinitis, Allergic, Perennial
- Sponsor
- ALK-Abelló A/S
- Enrollment
- 124
- Primary Endpoint
- Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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.
Investigators
Eligibility 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
Arms & Interventions
Placebo
Placebo rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks
Intervention: Placebo
MK-8237 6 Developmental Units (DU)
MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks
Intervention: MK-8237 6 DU
MK-8237 12 DU
MK-8237 12 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks
Intervention: MK-8237 12 DU
Outcomes
Primary Outcomes
Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24
Time Frame: Week 24
The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The 24-week TNSS was analyzed using the analysis of covariance (ANCOVA) model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.
Secondary Outcomes
- Average TNSS During EEC Challenge Session at Week 16(Week 16)
- Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 16(Week 16)
- Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 8(Week 8)
- Average Total Ocular Symptom Score (TOSS) During EEC Challenge Session at Week 24(Week 24)
- Average TOSS During EEC Challenge Session at Week 8(Week 8)
- HDM-specific Immunoglobulin G4 (IgG4) Levels at Week 8(Week 8)
- Average TNSS During EEC Challenge Session at Week 8(Week 8)
- Average Total Symptom Score (TSS [TNSS + TOSS]) During EEC Challenge Session at Week 24(Week 24)
- Change From Baseline in HDM-specific IgG4 Levels at Week 8(Time Frame: Baseline and Week 8)
- Percentage of Participants Who Experienced At Least One Adverse Event (AE)(From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks))
- Percentage of Participants Who Discontinued Study Drug Due to an AE(From first dose to last dose of treatment (Up to 24 weeks))
- Average TOSS During EEC Challenge Session at Week 16(Week 16)
- HDM-specific Immunoglobulin E (IgE) Levels at Week 8(Week 8)
- Change From Baseline in HDM-specific IgE Levels at Week 8(Baseline and Week 8)