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

Phase 2

Completed

• Conditions: Rhinitis; Conjunctivitis; Allergy; Rhinoconjunctivitis
• Interventions: Drug: Placebo; Biological: SCH 39641

• Registration Number: NCT00978029
• Lead Sponsor: ALK-Abelló A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-15
• Study First Posted: 2009-09-16
• Study Start: 2009-11
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Disposition First Submitted: 2010-04-13
• Disposition First Submitted QC: 2010-04-13
• Disposition First Posted: 2010-04-15
• Results First Submitted: 2014-04-25
• Results First Submitted QC: 2014-04-25
• Results First Posted: 2014-05-23
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo tablet sublingual, once daily
SCH 39641 6 Amb a 1-U	SCH 39641	6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an AIT, sublingual, once daily
SCH 39641 12 Amb a 1-U	SCH 39641	12 Amb a 1-U in an AIT, sublingual, once daily

Primary Outcome Measures

Name	Time	Method
The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs)	Up to Day 42	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Reporting Oral Pruritus	Up to Day 42	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.
Proportion of Participants Reporting Ear Pruritus	Up to Day 42	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.
Proportion of Participants Reporting Throat Irritation	Up to Day 42	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.
Proportion of Participants Reporting Mouth Oedema	Up to Day 42	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.
Proportion of Participants Who Discontinued Due to Adverse Events.	Up to Day 28	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.