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

Allergy Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978029
• Other study ID #: P06081
• Secondary ID: MK-3641-004
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2009
• Last updated: November 7, 2014
• Start date: November 2009
• Est. completion date: February 2010

Study information

• Verified date: November 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Allergy
• Conjunctivitis
• Rhinitis
• Rhinoconjunctivitis

Intervention

Drug:
• Placebo
Placebo sublingual tablet, once daily

Biological:
• SCH 39641
Allergy immunotherapy tablet (sublingual)
• SCH 39641
Allergy immunotherapy tablet (sublingual)

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	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes