Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05233)(COMPLETED)

Phase 2

Completed

• Conditions: Conjunctivitis; Rhinitis; Allergic, With Asthma
• Interventions: Biological: Placebo; Biological: SCH 39641 12 Amb a 1-U; Biological: SCH 39641 6 Amb a 1-U

• Registration Number: NCT00783198
• Lead Sponsor: ALK-Abelló A/S

Brief Summary

This study will evaluate the efficacy and safety of ragweed sublingual tablet (SCH 39641/MK-3641) compared with placebo in participants with ragweed-induced rhinoconjunctivitis over a one-year period. It is expected that ragweed allergic participants on one of the active arms of the trial will have decreased allergic rhinoconjunctivitis symptoms and require less allergy rescue medications during ragweed pollen season.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2008-10-30
• Study First Posted: 2008-10-31
• Study Start: 2009-09
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2014-04-25
• Results First Submitted QC: 2014-06-09
• Results First Posted: 2014-07-14
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 565

Inclusion Criteria

• Must have a clinical history of significant ragweed-induced allergic rhinoconjunctivitis of at least 2 years duration, with or without asthma and have received treatment during the previous RS.
• Must have a positive skin prick test response to Ambrosia artemisiifolia at Screening Visit.
• Must be positive for specific immunoglobulin E (IgE) against Ambrosia artemisiifolia at Screening Visit.
• Must have an forced expiratory volume in 1 second (FEV1) of at least 70% of predicted at Screening Visit.
• Safety laboratory tests and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor

Exclusion Criteria

• Clinical history of symptomatic seasonal allergic rhinitis and/or asthma having received regular medication, due to another allergen during or potentially overlapping the RS.
• Clinical history of significant symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the participant is regularly exposed.
• Receipt of an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms).
• Clinical history of severe asthma.
• Asthma requiring medium or high dose inhaled corticosteroids.
• History of anaphylaxis with cardiorespiratory symptoms.
• History of chronic urticaria and angioedema.
• Clinical history of chronic sinusitis 2 years prior to the Screening Visit.
• Current severe atopic dermatitis.
• Breast-feeding, pregnant, or intending to become pregnant.
• Had previous treatment by immunotherapy with ragweed allergen or any other allergen 5 years prior to Screening Visit.
• History of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (except for Ambrosia artemisiifolia), rescue medications, or self-injectable epinephrine.
• History of self-injectable epinephrine use.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
SCH 39641 12 Amb a 1-U	SCH 39641 12 Amb a 1-U	Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
SCH 39641 6 Amb a 1-U	SCH 39641 6 Amb a 1-U	Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks

Primary Outcome Measures

Name	Time	Method
Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS)	The 15-day period during the ragweed season with the highest moving pollen average	The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36. The sum of the rhinoconjunctivitis DSS and DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means for DSS+DMS were converted to adjusted means based on an analysis of variance (ANOVA) model with baseline asthmatic condition, pollen region and treatment group as fixed effects.

Secondary Outcome Measures

Name	Time	Method
Average Combined Rhinoconjunctivitis DSS and DMS Over the Entire RS	Approximately 5 weeks	The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36. The sum of the rhinoconjunctivitis DSS and DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means for DSS+DMS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.
Average Rhinoconjunctivitis DSS for the Peak RS	The 15-day period during the ragweed season with the highest moving pollen average	The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjuntivitis symptoms. Raw means for DSS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.
Average Rhinoconjunctivitis DSS for the Entire RS	Approximately 5 weeks	The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjuntivitis symptoms. Raw means for DSS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.
Average Rhinoconjunctivitis DMS for the Peak RS	The 15-day period during the ragweed season with the highest moving pollen average	Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36, with a lower score indicating less rhinoconjuntivitis medication use. Raw means for DMS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.