Rhinitis, Allergic, Nonseasonal, Rhinitis, Allergic, Perennial
Conditions
Brief 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.
Interventions
Sponsors
Merck Sharp & Dohme LLC
ALK-Abelló A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 42 days | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event. |
| Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | From first dose to last dose of treatment, up to 28 days | The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment. |
Participant flow
Recruitment details
Participants must have had a clinical history of allergic rhinitis/rhinoconjunctivitis (with or without asthma) to house dust of 6 months duration or more and had a positive skin prick test response to Dermatophagoides pteronyssinus or Dermatophagoides farina at the screening visit. Other inclusion and exclusion criteria applied.
Participants by arm
| Arm | Count |
|---|---|
| MK-8237 12 DU Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days | 65 |
| MK-8237 6 DU Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days | 65 |
| Placebo Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days | 65 |
| Total | 195 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 4 | 0 |
| Overall Study | Withdrawn by Parent/Guardian | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | MK-8237 12 DU | MK-8237 6 DU | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 14.5 Years STANDARD_DEVIATION 1.6 | 14.5 Years STANDARD_DEVIATION 1.7 | 14.3 Years STANDARD_DEVIATION 1.8 | 14.4 Years STANDARD_DEVIATION 1.7 |
| Sex: Female, Male Female | 25 Participants | 27 Participants | 21 Participants | 73 Participants |
| Sex: Female, Male Male | 40 Participants | 38 Participants | 44 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 29 / 65 | 27 / 65 | 12 / 65 |
| serious Total, serious adverse events | 0 / 65 | 0 / 65 | 0 / 65 |
Outcome results
Primary
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.
Time frame: From first dose to last dose of treatment, up to 28 days
Population: All randomized participants who receive at least one dose of study treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-8237 12 DU | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | 6.2 Percentage of participants |
| MK-8237 6 DU | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | 6.2 Percentage of participants |
| Placebo | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | 0 Percentage of participants |
95% CI: [0.4, 14.8]
95% CI: [0.4, 14.8]
Primary
Percentage of Participants Who Experienced At Least One Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.
Time frame: From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days
Population: All randomized participants who receive at least one dose of study treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-8237 12 DU | Percentage of Participants Who Experienced At Least One Adverse Event (AE) | 56.9 Percentage of participants |
| MK-8237 6 DU | Percentage of Participants Who Experienced At Least One Adverse Event (AE) | 53.8 Percentage of participants |
| Placebo | Percentage of Participants Who Experienced At Least One Adverse Event (AE) | 43.1 Percentage of participants |
95% CI: [-3.4, 30.3]
95% CI: [-6.4, 27.4]