A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adult Subjects With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Rhinitis, Allergic
- Sponsor
- ALK-Abelló A/S
- Enrollment
- 784
- Primary Endpoint
- Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This study will evaluate the efficacy and safety of ragweed sublingual tablet (SCH 39641/MK-3641/Amb a 1-U) 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.
Investigators
Eligibility Criteria
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 ragweed season (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 one 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.
- •Must be willing to give written informed consent and be able to adhere to dose and visit schedules.
- •Female participants of childbearing potential must be using a medically acceptable and adequate form of birth control. These include: hormonal contraceptives as prescribed by a physician (oral, hormonal vaginal ring, hormonal implant or depot injectable); medically prescribed intra-uterine device; medically prescribed topically-applied transdermal contraceptive patch; double-barrier method (eg, condom in combination with a spermicide).
- •Female participants of childbearing potential should be counseled in the appropriate use of birth control while in the study. Female participants who are not currently sexually active must and consent to use one of the above-mentioned methods if she becomes sexually active during the study.
- •Female participants of childbearing potential must have a negative urine pregnancy test at Screening Visit. Women who have been surgically sterilized or at least 1 year postmenopausal are not considered to be of childbearing potential.
Exclusion Criteria
- •Clinical history of symptomatic seasonal allergic rhinitis and/or asthma having received regular medication, due to another 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 (ICS).
- •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, pregnancy, or intending to become pregnant.
Outcomes
Primary Outcomes
Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS)
Time Frame: 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), with a lower score indicating less rhinoconjunctivitis symptoms. Rhinoconjunctivitis DMS was based on use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. The sum of the rhinoconjunctivitis DSS+DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.
Secondary Outcomes
- Average Rhinoconjunctivitis DSS for the Peak RS(The 15-day period during the ragweed season with the highest moving pollen average)
- Average Rhinoconjunctivitis DMS for the Peak RS(The 15-day period during the ragweed season with the highest moving pollen average)
- Average Combined Rhinoconjunctivitis DSS and DMS Over the Entire RS(Approximately 5 weeks)
- Average Rhinoconjunctivitis DSS for the Entire RS(Approximately 5 weeks)