A Study of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet in Adults With Ragweed Allergies (P05751)

Study Overview
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Brief Summary
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This study assessed the safety profile of short ragweed (Ambrosia artemisiifolia) in participants with ragweed-induced rhinoconjunctivitis with or without asthma. The primary objective was to compare treatment-emergent adverse events (AEs) for participants treated with short ragweed allergy immunotherapy tablet (AIT) with those treated with placebo.

Official Title
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A 28-Day Study Evaluating the Safety of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet (SCH 39641/MK-3641) Treatment in Ragweed Allergic Adults (Phase 3, Protocol No.P05751)

Conditions
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Allergy

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical history of physician-diagnosed ragweed-induced allergic rhinoconjunctivitis of 2 years duration or more, with or without asthma Must have a positive skin prick test response to Ambrosia artemisiifolia Must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value Clinical laboratory tests, electrocardiogram (ECG) and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor Females of child-bearing potential must agree to use medically accepted methods of contraception Exclusion Criteria: Unstable asthma or has experienced an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids in previous 3 months Received an immunosuppressive treatment within 3 months History of anaphylaxis with cardio-respiratory symptoms. History of chronic urticaria or angioedema Current severe atopic dermatitis Female subject who is breastfeeding, pregnant, or intending to become pregnant Has received maintenance doses of immunotherapy with ragweed extract for ≥1 month within the last 5 years History of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia), or self-injectable epinephrine Unable to or will not comply with the use of self-injectable epinephrine Participating in any other clinical trial

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCH 39641 12 Amb a 1-U<br>12 Units short ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) extract in an AIT, sublingual, once daily. | Biological: SCH 39641<br>* Rapidly dissolving tablet sublingually once daily<br>* Other names: MK-3641;|
| Placebo Comparator: Placebo<br>Matching placebo tablet, sublingual, once daily. | Drug: Placebo for SCH 39641<br>* Rapidly dissolving tablet sublingually once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-emergent Adverse Events (AEs) | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number 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 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Oral Pruritus. | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with oral pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | Up to Day 35 | 
| Number of Participants Reporting Ear Pruritus | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with ear pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | Up to Day 35 | 
| Number of Participants Reporting Throat Irritation | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with throat irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | Up to Day 35 | 
| Number of Participants Reporting Mouth Oedema | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with mouth oedema were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | Up to Day 35 | 
| Number of Participants Reporting Eye Pruritus | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with eye pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | Up to Day 35 | 
| Number of Participants Reporting Nasal Passage Irritation | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with nasal passage irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | Up to Day 35 | 
| Number of Participants Reporting Skin Pruritus | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with skin pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | Up to Day 35 | 
| Number of Participants Who Discontinued Due to Treatment-emergent AEs | Participants were treated with either SCH 39641 12 Amb a 1-U or placebo for 28 days, and the number who discontinued due to 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 28 | 

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