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

Rhinitis, Allergic, Perennial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01678807
• Other study ID #: 8237-008
• Secondary ID: MK-8237-008
• Status: Completed
• Phase: Phase 1
• First received: August 31, 2012
• Last updated: September 14, 2017
• Start date: October 2012
• Est. completion date: May 2013

Study information

• Verified date: September 2017
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Nonseasonal
• Rhinitis, Allergic, Perennial

Intervention

Biological:
• MK-8237 6 DU

• MK-8237 12 DU

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ALK-Abelló A/S	Merck Sharp & Dohme Corp.

References & Publications (1)

Maloney J, Prenner BM, Bernstein DI, Lu S, Gawchik S, Berman G, Kaur A, Li Z, Nolte H. Safety of house dust mite sublingual immunotherapy standardized quality tablet in children allergic to house dust mites. Ann Allergy Asthma Immunol. 2016 Jan;116(1):59- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days
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.	From first dose to last dose of treatment, up to 28 days