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

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ALK-Abelló A/S; Merck Sharp & Dohme Corp.

Criteria

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.