Clinical trial NCT01700192: Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)
Official title: A One-year Placebo-Controlled Study Evaluating the Efficacy and Safety of the House Dust Mite Sublingual Allergen Immunotherapy Tablet (SCH 900237/MK 8237) in Children and Adult Subjects With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma (Protocol No. P05607/001)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Nonseasonal
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-10-04
Enrollment: 1482
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of MK-8237 (SCH 900237) in the treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis (AR/ARC) in children and adults.

The primary hypothesis of this study is that administration of MK-8237, compared to placebo, results in significant reduction in the average total combined rhinitis score (TCRS).


Eligibility criteria: Inclusion Criteria:

* History of AR/ARC 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) an acceptable method of birth control within the projected duration of the study
* Able to read, understand and complete questionnaires and diaries

Exclusion Criteria:

* Clinically relevant history of symptomatic ARC caused by animal dander, molds and/or cockroach (e.g. present in the home, job, daycare, etc.) or other perennial allergen
* History of symptomatic seasonal ARC and/or asthma due to an allergen to which the participant is sensitized and regularly exposed
* Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyposis)
* Received an immunosuppressive treatment within 3 months prior to screening
* Unstable 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 short-acting beta agonists \[SABAs\]) at any time within 3 months prior to screening
* Asthma requiring high-dose inhaled corticosteroids (ICS) within 6 months prior to screening
* History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause or inhalant allergen
* History of chronic urticaria and/or angioedema within 2 years prior to screening
* History of chronic sinusitis during 2 years prior to screening
* Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study
* Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening
* Previous exposure to MK-8237
* Receiving ongoing treatment with any specific immunotherapy at screening
* Known history of allergy, hypersensitivity or intolerance to investigational medicinal products (except for D. pteronyssinus and/or D. farinae), rescue medications or self-injectable epinephrine
* Unable to meet medication washout requirements prior to screening
* Unable or unwilling to comply with the use of self-injectable epinephrine
* Business or personal relationship with investigational site personnel or Sponsor who is directly involved with the conduct of the study
* Likely to travel for extended periods of time during the efficacy assessment period
* Participating in a different investigational study at any site during this study

Primary outcomes:
measure: Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment
timeFrame: Last 8 weeks of treatment (Weeks 44 to 52)
measure: Number of Participants Who Experience At Least One Adverse Event (AE)
timeFrame: Up to 54 weeks
measure: Number of Participants Who Discontinue Study Drug Due to an AE
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment
timeFrame: Last 8 weeks of treatment (Weeks 44 to 52)
measure: Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment
timeFrame: Last 8 weeks of treatment (Weeks 44 to 52)
measure: Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment
timeFrame: Last 8 weeks of treatment (Weeks 44 to 52)
measure: Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment
timeFrame: Last 8 weeks of treatment (Weeks 44 to 52)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Nolte H, Bernstein DI, Nelson HS, Kleine-Tebbe J, Sussman GL, Seitzberg D, Rehm D, Kaur A, Li Z, Lu S. Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2016 Dec;138(6):1631-1638. doi: 10.1016/j.jaci.2016.06.044. Epub 2016 Aug 10.
citation: Fortescue R, Kew KM, Leung MST. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev. 2020 Sep 14;9(9):CD011293. doi: 10.1002/14651858.CD011293.pub3.
citation: Bernstein DI, Kleine-Tebbe J, Nelson HS, Bardelas JA Jr, Sussman GL, Lu S, Rehm D, Svanholm Fogh B, Nolte H. SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration. Ann Allergy Asthma Immunol. 2018 Jul;121(1):105-110. doi: 10.1016/j.anai.2018.04.007. Epub 2018 Apr 12.
citation: Nolte H, Bernstein DI, Sussman GL, Svanholm Fogh B, Lu S, Husoy B, Nelson HS. Impact of Adverse Event Solicitation on the Safety Profile of SQ House Dust Mite Sublingual Immunotherapy Tablet. J Allergy Clin Immunol Pract. 2018 Nov-Dec;6(6):2081-2086.e1. doi: 10.1016/j.jaip.2018.01.037. Epub 2018 Feb 10.