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

Allergy Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01469182
• Other study ID #: P05751
• Secondary ID: MK-3641
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2011
• Last updated: December 2, 2014
• Start date: November 2011
• Est. completion date: April 2012

Study information

• Verified date: December 2014
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 914
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy
• Hypersensitivity

Intervention

Biological:
• SCH 39641
Rapidly dissolving tablet sublingually once daily

Drug:
• Placebo for SCH 39641
Rapidly dissolving tablet sublingually once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes