A Study of SCH 697243 in Participants With Grass Pollen Allergy Symptoms, With or Without Asthma (P08067)

January 18, 2017 updated by: ALK-Abelló A/S

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1501

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Biological: Placebo for SCH 697243
One dissolving tablet sublingually once daily
Experimental: SCH 697243
Biological: Grass (Phleum pratense) pollen allergen extract
One dissolving tablet sublingually once daily
Other Names:
  • SCH 697243

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Entire GPS (expected average duration of 5 to 6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Rhinoconjunctivitis DSS Over the Entire GPS
Time Frame: Entire GPS (expected average duration of 5 to 6 weeks)
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.
Entire GPS (expected average duration of 5 to 6 weeks)
Average Total Combined Rhinoconjunctivitis DSS and Rhinoconjunctivitis DMS Over the Peak GPS
Time Frame: Peak GPS (expected average duration of 2 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.
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
Time Frame: Peak GPS (expected average duration of 2 weeks)
The RQLQ12+ consists of 7 domains: Activities, Sleep, Non-Nose/Eye Symptoms, Practical Problems, Nasal Symptoms, Eye Symptoms, Emotional. Participants reflect on their experience over the previous 7 days and assess 28 items on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0-6 [mean of all domain scores]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis.
Peak GPS (expected average duration of 2 weeks)
Average Rhinoconjunctivitis DMS Over the Entire GPS
Time Frame: Entire GPS (expected average duration of 5 to 6 weeks)
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.
Entire GPS (expected average duration of 5 to 6 weeks)
Average Rhinoconjunctivitis DSS Over the Peak GPS
Time Frame: Peak GPS (expected average duration of 2 weeks)
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.
Peak GPS (expected average duration of 2 weeks)
Average Rhinoconjunctivitis DMS Over the Peak GPS
Time Frame: Peak GPS (expected average duration of 2 weeks)
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.
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)
Time Frame: Peak GPS (expected average duration of 2 weeks)
For PRQLQ, participants assessed a total of 19 items within 5 domains: Nose Symptoms, Eye Symptoms, Practical Problems, Activity Limitation and Other Symptoms, each on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0 to 6 [mean of all domain scores]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis.
Peak GPS (expected average duration of 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

April 6, 2011

First Submitted That Met QC Criteria

June 28, 2011

First Posted (Estimate)

June 30, 2011

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P08067
  • MK-7243-001 (Other Identifier: Merck Protocol ID)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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