Phase 2
N=124
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)
Rhinitis, Allergic, Perennial · Rhinitis, Allergic, Nonseasonal
Bottom Line
View on ClinicalTrials.gov: NCT01644617 ↗Enrolled (actual)
124
Serious AEs
0.8%
Results posted
Feb 2017
Primary outcome: Primary: Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24 — 3.83; 5.47; 7.45 Score on a Scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); MK-8237 6 DU (Drug); MK-8237 12 DU (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ALK-Abelló A/S
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24 |
3.83; 5.47; 7.45 | <0.001 sig |
| SECONDARY Average TNSS During EEC Challenge Session at Week 16 |
4.82; 5.67; 6.90 | <0.001 sig |
| SECONDARY Average TNSS During EEC Challenge Session at Week 8 |
5.34; 6.16; 6.71 | 0.007 sig |
| SECONDARY Average Total Symptom Score (TSS [TNSS + TOSS]) During EEC Challenge Session at Week 24 |
4.43; 6.62; 9.27 | <0.001 sig |
| SECONDARY Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 16 |
5.95; 7.21; 8.58 | <0.001 sig |
| SECONDARY Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 8 |
6.51; 7.65; 8.48 | 0.004 sig |
| SECONDARY Average Total Ocular Symptom Score (TOSS) During EEC Challenge Session at Week 24 |
0.61; 1.10; 1.87 | <0.001 sig |
| SECONDARY Average TOSS During EEC Challenge Session at Week 16 |
1.14; 1.54; 1.67 | 0.082 |
| SECONDARY Average TOSS During EEC Challenge Session at Week 8 |
1.18; 1.45; 1.79 | 0.023 sig |
| SECONDARY HDM-specific Immunoglobulin E (IgE) Levels at Week 8 |
1.77; 1.64; 1.25; 1.80; 1.69; 1.31 | — |
| SECONDARY HDM-specific Immunoglobulin G4 (IgG4) Levels at Week 8 |
-0.31; -0.33; -0.57; -0.32; -0.31; -0.62 | — |
| SECONDARY Change From Baseline in HDM-specific IgE Levels at Week 8 |
0.63; 0.50; 0.08; 0.59; 0.46; 0.07 | <0.001 sig |
| SECONDARY Change From Baseline in HDM-specific IgG4 Levels at Week 8 |
0.23; 0.19; -0.00; 0.32; 0.24; -0.01 | <0.001 sig |
| SECONDARY Percentage of Participants Who Experienced At Least One Adverse Event (AE) |
90.5; 87.8; 78.0 | — |
| SECONDARY Percentage of Participants Who Discontinued Study Drug Due to an AE |
7.1; 0.0; 14.6 | — |
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.
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
- 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
Data sourced from ClinicalTrials.gov (NCT01644617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.