A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Grass (Phleum Pratense) Sublingual Tablet (SCH 697243) in Subjects Between 5 and 65 Years of Age, With a History of Grass Pollen-Induced Rhinoconjunctivitis, With or Without Asthma (Protocol No. P08067)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Rhinitis Allergic
- Sponsor
- ALK-Abelló A/S
- Enrollment
- 1501
- Primary Endpoint
- Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This is a study to evaluate the efficacy and safety of grass sublingual tablet (SCH 697243) versus placebo in the treatment of grass pollen-induced allergic hayfever symptoms. Participants will receive either the sublingual grass tablet or a placebo tablet during the study. It is expected that those participants receiving the active sublingual grass tablet will have less hayfever symptoms and need less medications to treat hayfever symptoms during the grass pollen season.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must have a clinical history of significant allergic rhinoconjunctivitis to grass (with or without asthma)
- •Must have a positive skin prick test response to Phleum pratense (Timothy grass)
- •Must be positive for specific immunoglobulin E (IgE) against Phleum pratense (Timothy grass)
- •Must have an forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at
- •Safety laboratory tests and vital signs conducted at the Screening Visit must be within normal
- •limits or clinically acceptable to the investigator/sponsor
Exclusion Criteria
- •Has a clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to another allergen during or potentially overlapping the GPS
- •Has a clinical history of significant symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the participant is regularly exposed
- •Has received an immunosuppressive treatment within 3 months prior to the Screening Visit
- •Has a clinical history of severe asthma
- •Has a history of anaphylaxis with cardiorespiratory symptoms
- •Has a history of self-injectable epinephrine use
- •Has a history of chronic urticaria and angioedema
- •Has a clinical history of chronic sinusitis during the 2 years prior to the Screening Visit
- •Has current severe atopic dermatitis
- •Is breast-feeding, pregnant, or intending to become pregnant
Outcomes
Primary Outcomes
Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS)
Time Frame: Entire GPS (expected average duration of 5 to 6 weeks)
The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications. For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.
Secondary Outcomes
- Average Rhinoconjunctivitis DMS Over the Entire GPS(Entire GPS (expected average duration of 5 to 6 weeks))
- Average Total Combined Rhinoconjunctivitis DSS and Rhinoconjunctivitis DMS Over the Peak GPS(Peak GPS (expected average duration of 2 weeks))
- Average Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities for Participants ≥12 Years of Age (RQLQ12+) Over the Peak GPS(Peak GPS (expected average duration of 2 weeks))
- Average Rhinoconjunctivitis DSS Over the Entire GPS(Entire GPS (expected average duration of 5 to 6 weeks))
- Average Rhinoconjunctivitis DSS Over the Peak GPS(Peak GPS (expected average duration of 2 weeks))
- Average Rhinoconjunctivitis DMS Over the Peak GPS(Peak GPS (expected average duration of 2 weeks))
- Average Paediatric Standardised Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score Over the Peak GPS (Participants 6 to <12 Years of Age)(Peak GPS (expected average duration of 2 weeks))