Trial Outcomes & Findings for Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008) (NCT NCT01678807)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

195 participants

Primary outcome timeframe

From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days

Results posted on

2017-09-15

Participant Flow

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.

Participant milestones

Participant milestones
Measure	MK-8237 12 Development Units (DU) Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days	MK-8237 6 DU Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days	Placebo Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
Overall Study STARTED	65	65	65
Overall Study COMPLETED	61	60	65
Overall Study NOT COMPLETED	4	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	MK-8237 12 Development Units (DU) Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days	MK-8237 6 DU Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days	Placebo Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
Overall Study Adverse Event	4	4	0
Overall Study Withdrawn by Parent/Guardian	0	1	0

Baseline Characteristics

Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-8237 12 DU n=65 Participants Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days	MK-8237 6 DU n=65 Participants Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days	Placebo n=65 Participants Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days	Total n=195 Participants Total of all reporting groups
Age, Continuous	14.5 Years STANDARD_DEVIATION 1.6 • n=5 Participants	14.5 Years STANDARD_DEVIATION 1.7 • n=7 Participants	14.3 Years STANDARD_DEVIATION 1.8 • n=5 Participants	14.4 Years STANDARD_DEVIATION 1.7 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	27 Participants n=7 Participants	21 Participants n=5 Participants	73 Participants n=4 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	38 Participants n=7 Participants	44 Participants n=5 Participants	122 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	MK-8237 12 DU n=65 Participants Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days	MK-8237 6 DU n=65 Participants Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days	Placebo n=65 Participants Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
Percentage of Participants Who Experienced At Least One Adverse Event (AE)	56.9 Percentage of participants	53.8 Percentage of participants	43.1 Percentage of participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	MK-8237 12 DU n=65 Participants Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days	MK-8237 6 DU n=65 Participants Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days	Placebo n=65 Participants Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event	6.2 Percentage of participants	6.2 Percentage of participants	0 Percentage of participants

Adverse Events

MK-8237 12 DU

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

MK-8237 6 DU

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MK-8237 12 DU n=65 participants at risk Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days	MK-8237 6 DU n=65 participants at risk Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days	Placebo n=65 participants at risk Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
Ear and labyrinth disorders Ear pruritus	1.5% 1/65 • Number of events 1 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment	7.7% 5/65 • Number of events 22 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment	1.5% 1/65 • Number of events 2 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment
Gastrointestinal disorders Lip swelling	10.8% 7/65 • Number of events 10 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment	4.6% 3/65 • Number of events 5 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment	0.00% 0/65 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment
Gastrointestinal disorders Oral pruritus	16.9% 11/65 • Number of events 31 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment	16.9% 11/65 • Number of events 40 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment	7.7% 5/65 • Number of events 11 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment
Gastrointestinal disorders Paraesthesia oral	7.7% 5/65 • Number of events 13 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment	9.2% 6/65 • Number of events 11 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment	1.5% 1/65 • Number of events 1 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment
Gastrointestinal disorders Tongue pruritus	9.2% 6/65 • Number of events 14 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment	13.8% 9/65 • Number of events 19 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment	0.00% 0/65 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment
Infections and infestations Upper respiratory tract infection	1.5% 1/65 • Number of events 1 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment	7.7% 5/65 • Number of events 5 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment	3.1% 2/65 • Number of events 2 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment
Respiratory, thoracic and mediastinal disorders Throat irritation	20.0% 13/65 • Number of events 36 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment	18.5% 12/65 • Number of events 24 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment	6.2% 4/65 • Number of events 4 • From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days Adverse events for all randomized participants who receive at least one dose of study treatment

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor has the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Publication restrictions are in place

Restriction type: OTHER