Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)

ALK-Abelló

Status and phase: Completed; Phase 3

Conditions: Rhinitis, Allergic, Nonseasonal; Rhinitis, Allergic, Perennial

Treatments: Drug: Rescue Medication: Loratadine tablets; Biological: MK-8237 tablets; Drug: Rescue Medication: Mometasone furoate nasal spray; Drug: Rescue Medication: Self-Injectable Epinephrine; Drug: Rescue Medication: Olopatadine ophthalmic drops; Biological: Placebo tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT01700192

P05607

MK-8237-001 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 1,482 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,482 participants in 2 patient groups, including a placebo group

MK-8237

Experimental group

Description:

MK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily (q.d.).

Treatment:

Drug: Rescue Medication: Loratadine tablets

Drug: Rescue Medication: Olopatadine ophthalmic drops

Drug: Rescue Medication: Mometasone furoate nasal spray

Biological: MK-8237 tablets

Drug: Rescue Medication: Self-Injectable Epinephrine

Placebo

Placebo Comparator group

Description:

Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.

Treatment:

Drug: Rescue Medication: Loratadine tablets

Drug: Rescue Medication: Olopatadine ophthalmic drops

Drug: Rescue Medication: Mometasone furoate nasal spray

Drug: Rescue Medication: Self-Injectable Epinephrine

Biological: Placebo tablets