Phase 1
N=195
Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008)
Rhinitis, Allergic, Perennial · Rhinitis, Allergic, Nonseasonal
Bottom Line
View on ClinicalTrials.gov: NCT01678807 ↗Enrolled (actual)
195
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Percentage of Participants Who Experienced At Least One Adverse Event (AE) — 56.9; 53.8; 43.1 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- MK-8237 6 DU (Biological); MK-8237 12 DU (Biological); Placebo (Biological)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- ALK-Abelló A/S
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced At Least One Adverse Event (AE) |
56.9; 53.8; 43.1 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event |
6.2; 6.2; 0 | — |
Summary
The purpose of this study is to evaluate the safety of two doses (6 Development Units [DU] and 12 DU) of MK-8237 sublingual tablets compared to Placebo in adolescents with house dust mite-induced allergic rhinitis/rhinoconjunctivitis. The primary hypothesis is that at least one dose of MK-8237 sublingual tablet is safe and well-tolerated in adolescents with house dust mite-induced allergic rhinitis/rhinoconjunctivitis.
Eligibility Criteria
Inclusion Criteria
- History of physician-diagnosed allergic rhinitis/rhinoconjunctivitis to house dust of at least 6 months duration (with or without asthma)
- History of controlled asthma for the prior 1 month if participant has asthma, defined by not exceeding 2 days of symptoms per week; not more than 2 days of albuterol/short acting beta-agonist [SABA] use per week; and not wakening more than twice a month at night due to asthma symptoms
- Agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control from screening and through the duration of the study
Exclusion Criteria
- Unable to meet medication washout requirements
- History of chronic urticaria and/or chronic angioedema within prior 2 years
- History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy due to an unknown cause or to an inhalant allergen
- Unstable, uncontrolled 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 SABAs) at any time within prior 3 months
- History of chronic sinusitis during within prior 2 years
- Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study
- Known history of allergy, hypersensitivity or intolerance to investigational medicinal products except for Dermatophagoides pteronyssinus (D. pteronyssinus) and/or Dermatophagoides farina (D. farina) or self-injectable epinephrine
- Business or personal relationship with investigational site personnel or Sponsor who is directly involved with the conduct of the trial
Data sourced from ClinicalTrials.gov (NCT01678807). 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.