Safety Study of Ragweed Allergy Immunotherapy Tablet in Subjects 50 Years of Age and Older (Study P06081)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this study was to assess the safety and tolerability of a ragweed allergy immunotherapy tablet (AIT) administered sublingually (under-the tongue) in subjects 50 years of age and older with ragweed-induced rhinoconjunctivitis, with or without asthma.

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Detailed Description

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Conditions

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Rhinoconjunctivitis Rhinitis Conjunctivitis Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Matching placebo tablet sublingual, once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo sublingual tablet, once daily

SCH 39641 6 Amb a 1-U

6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an AIT, sublingual, once daily

Group Type EXPERIMENTAL

SCH 39641

Intervention Type BIOLOGICAL

Allergy immunotherapy tablet (sublingual)

SCH 39641 12 Amb a 1-U

12 Amb a 1-U in an AIT, sublingual, once daily

Group Type EXPERIMENTAL

SCH 39641

Intervention Type BIOLOGICAL

Allergy immunotherapy tablet (sublingual)

Interventions

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Placebo

Placebo sublingual tablet, once daily

Intervention Type DRUG

SCH 39641

Allergy immunotherapy tablet (sublingual)

Intervention Type BIOLOGICAL

SCH 39641

Allergy immunotherapy tablet (sublingual)

Intervention Type BIOLOGICAL

Other Intervention Names

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MK-3641 MK-3641

Eligibility Criteria

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Inclusion Criteria

* Subject must be 50 years of age or older, of either sex, and of any race/ethnicity.
* Subject must have a clinical history of ragweed-induced allergic rhinoconjunctivitis with or without asthma.
* Subject must have a positive skin prick test response to Ambrosia artemisiifolia at the Screening Visit
* Subject must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at the Screening Visit and at Randomization.
* A subject's clinical laboratory tests, electrocardiogram (ECG) and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator.

Exclusion Criteria

* Subject with asthma who requires inhaled corticosteroids for the treatment of their asthma during the study period.
* Subject requiring anti-allergy medications during the time period from randomization to study completion.
* Subject who has received an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms).
* Subject with a history of anaphylaxis with cardiorespiratory symptoms.
* Subject with a history of chronic urticaria or angioedema.
* Subject with current severe atopic dermatitis.
* Female subject who is breastfeeding, pregnant, or intending to become pregnant.
* Subject with a history of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia), or self-injectable epinephrine.
* Subject with a history of self-injectable epinephrine use.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No