Clinical trial NCT01385371: A Study of SCH 697243 in Participants With Grass Pollen Allergy Symptoms, With or Without Asthma (P08067)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis Allergic
Conjunctivitis
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2011-06-30
Enrollment: 1501
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Screening

- 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
* Had previous treatment by immunotherapy with any grass pollen allergen for more than 1 month within the 5 years prior to the Screening Visit
* Ongoing treatment with any specific immunotherapy at the time of the Screening Visit
* Has a known history of allergy, hypersensitivity or intolerance to the ingredients of the study drug (except for Phleum pratense), rescue medications, or self-injectable epinephrine
* Has any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study. Specific examples include but are not limited to hypertension being treated with beta blockers, coronary artery disease, arrhythmia, stroke, ocular conditions requiring topical beta blockers, any condition requiring the use of beta blockers
* Has used any investigational drugs within 30 days of the Screening Visit
* Is participating in any other clinical study
* Is a family member of the investigational study staff conducting this study
* Is unable to meet medication washout requirements
* Is unlikely to be able to complete the trial, for any reason, or likely to travel for extended periods of time during the GPS, which in the opinion of the investigator will compromise the data
* Has a clinically significant abnormal vital sign or laboratory value that would preclude participation in the study

Primary outcomes:
measure: Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS)
timeFrame: Entire GPS (expected average duration of 5 to 6 weeks)
Secondary outcomes:
measure: Average Rhinoconjunctivitis DSS Over the Entire GPS
timeFrame: Entire GPS (expected average duration of 5 to 6 weeks)
measure: Average Total Combined Rhinoconjunctivitis DSS and Rhinoconjunctivitis DMS Over the Peak GPS
timeFrame: Peak GPS (expected average duration of 2 weeks)
measure: Average Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities for Participants ≥12 Years of Age (RQLQ12+) Over the Peak GPS
timeFrame: Peak GPS (expected average duration of 2 weeks)
measure: Average Rhinoconjunctivitis DMS Over the Entire GPS
timeFrame: Entire GPS (expected average duration of 5 to 6 weeks)
measure: Average Rhinoconjunctivitis DSS Over the Peak GPS
timeFrame: Peak GPS (expected average duration of 2 weeks)
measure: Average Rhinoconjunctivitis DMS Over the Peak GPS
timeFrame: Peak GPS (expected average duration of 2 weeks)
measure: Average Paediatric Standardised Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score Over the Peak GPS (Participants 6 to <12 Years of Age)
timeFrame: Peak GPS (expected average duration of 2 weeks)
Other outcomes:
Locations:
Study officials:
References:
citation: Maloney J, Bernstein DI, Nelson H, Creticos P, Hebert J, Noonan M, Skoner D, Zhou Y, Kaur A, Nolte H. Efficacy and safety of grass sublingual immunotherapy tablet, MK-7243: a large randomized controlled trial. Ann Allergy Asthma Immunol. 2014 Feb;112(2):146-153.e2. doi: 10.1016/j.anai.2013.11.018. Epub 2013 Dec 21.
citation: Nolte M, Barber D, Maloney J, Li Z, Kaur A, Galan A, Andersen JS, Nolte H. Timothy specific IgE levels are associated with efficacy and safety of timothy grass sublingual immunotherapy tablet. Ann Allergy Asthma Immunol. 2015 Dec;115(6):509-515.e2. doi: 10.1016/j.anai.2015.09.018. Epub 2015 Oct 21.
citation: Hebert J, Blaiss M, Waserman S, Kim H, Creticos P, Maloney J, Kaur A, Li Z, Nelson H, Nolte H. The efficacy and safety of the Timothy grass allergy sublingual immunotherapy tablet in Canadian adults and children. Allergy Asthma Clin Immunol. 2014 Oct 30;10(1):53. doi: 10.1186/1710-1492-10-53. eCollection 2014.