Status:
COMPLETED
A Study of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet in Adults With Ragweed Allergies (P05751)
Lead Sponsor:
ALK-Abelló A/S
Conditions:
Allergy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
914 Patients enrolled
Trial Details
Trial ID
NCT01469182
Start Date
November 1 2011
End Date
April 1 2012
Last Update
March 3 2017
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