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

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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