House Dust Induced Rhinitis/Rhinoconjunctivitis MedDRA version: 14.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: MK-8237, SCH 900237
Product Code: MK-8237, SCH 900237
Pharmaceutical Form: Oral lyophilisate
INN or Proposed INN: House Dust Mite Extract, Dermatophagoides farinae (der far)
Current Spon
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Subject is male or female and =18 years of age ? Subject has AR/ARC to house dust of >=1 year duration ? TNSS >= 6 of 12 during the screening EEC session. ? Positive skin prick test response to D. pteronyssinus and/or D. farinae (Allergopharma) at the Screening Visit (>=3mm wheal). ? Serum specific IgE to D. pteronyssinus and/or D. farinae >= Class 2. ? FEV1 >= 70% of predicted value at the Screening and Randomization Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 115 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: ? Subject is sensitized and regularly exposed seasonal allergens which could potentially interfere with EEC sessions. ? Previous immunotherapy with HDM for >=1 month within the 3 years of V3 ? Ongoing treatment with immunotherapy ? Unstable or severe asthma; history of a life-threatening asthma attack or deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids within 3 months prior to Screening. ? Requirement for medium or high-dose ICS within 12 months of V1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the dose-related efficacy of MK-8237 sublingual house dust mite (HDM) tablet versus placebo in the treatment of HDM-induced rhinitis based on the average total nasal symptom score (TNSS) determined during the chamber challenge session at Week 24.;Primary end point(s): Average TNSS during the chamber session at Week 24.;Timepoint(s) of evaluation of this end point: Week 24;Secondary Objective: Key Secondary Objectives Evaluate onset of action of MK-8237 versus placebo for HDM-induced rhinitis based on average TNSS during chamber sessions at Week 8, 16, and 24. Evaluate dose response of MK-8237 versus placebo for HDM-induced rhinitis based on average TNSS during chamber sessions at Week 8, 16, and 24. Evaluate efficacy of MK-8237 versus placebo for HDM-induced rhinoconjunctivitis based on average symptom score (TSS) [sum of TNSS and TOSS, total ocular symptom score] during chamber session at Week 24. Other Secondary Objectives Evaluate efficacy of MK-8237 vs. placebo for HDM-induced rhinoconjunctivitis based on the average DSS (sum of TNSS and TOSS) during chamber sessions at Week 8 and 16. Evaluate the efficacy of MK-8237 vs placebo for HDM-induced conjunctivitis based on average TOSS during chamber sessions at Week 8, 16, and 24. Evaluate immunologic parameters during trial period, including HDM specific IgE and IgG4. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Efficacy Endpoint(s) 1. Average TNSS during chamber sessions at Week 8 and 16. 2. Average TSS (sum of TNSS and TOSS) during the chamber session at Week 24. Other Secondary Efficacy Endpoint(s) 1. Average TSS during the chamber sessions at Week 8 and 16. 2. Average TOSS during chamber sessions at Week 8, 16, and 24. 3. Immunologic parameters during the study period, including specific IgE and IgG4 ;Timepoint(s) of evaluation of this end point: Week 8, 16 and 24 | — |
Countries
Austria
Contacts
Public ContactClinical Project Manager
Merck Sharp & Dohme Ges.m.b.H
Outcome results
None listed