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

Study Overview
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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.

Official Title
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A 28-Day Study Evaluating the Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adult Subjects 50 Years of Age and Older With Ragweed-Induced Rhinoconjunctivitis (Protocol No. P06081)

Conditions
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Rhinoconjunctivitis, Rhinitis, Conjunctivitis, Allergy

Intervention / Treatment
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* Drug: Placebo
* Biological: SCH 39641
* Biological: SCH 39641


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Matching placebo tablet sublingual, once daily | Drug: Placebo<br>* Placebo sublingual tablet, once daily<br>|
| Experimental: SCH 39641 6 Amb a 1-U<br>6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an AIT, sublingual, once daily | Biological: SCH 39641<br>* Allergy immunotherapy tablet (sublingual)<br>* Other names: MK-3641;|
| Experimental: SCH 39641 12 Amb a 1-U<br>12 Amb a 1-U in an AIT, sublingual, once daily | Biological: SCH 39641<br>* Allergy immunotherapy tablet (sublingual)<br>* Other names: MK-3641;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs) | Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization. | Up to Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Reporting Oral Pruritus | Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with oral pruritus were reported. | Up to Day 42 | 
| Proportion of Participants Reporting Ear Pruritus | Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with ear pruritus were reported. | Up to Day 42 | 
| Proportion of Participants Reporting Throat Irritation | Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with throat irritation were reported. | Up to Day 42 | 
| Proportion of Participants Reporting Mouth Oedema | Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with mouth oedema were reported. | Up to Day 42 | 
| Proportion of Participants Who Discontinued Due to Adverse Events. | Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with AEs leading to study discontinuation were reported. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Up to Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunotherapy