Status:
COMPLETED
A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis
Lead Sponsor:
ALK-Abelló A/S
Collaborating Sponsors:
Syneos Health
Conditions:
Allergy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a 2 year clinical study to compare 5-grass mix SLIT-drops with placebo in relieving grass pollen-induced rhinoconjunctivitis symptoms and in use of symptom-relieving medication during the seco...
Detailed Description
This trial is a 2 year, parallel-group, double-blind, placebo-controlled phase III trial to evaluate efficacy and safety of the 5-grass mix SLIT-drops in adults with grass pollen-induced rhinoconjunct...
Eligibility Criteria
Inclusion
- Male or female aged ≥18 years on the day informed consent is obtained
- A clinical history of grass pollen-induced allergic rhinoconjunctivitis for two years or more with or without asthma
- A clinical history of severe allergic rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep) induced by grass pollen, which remain troublesome despite symptomatic treatment with antihistamines, nasal steroids or eye drops during the previous grass pollen season
- Positive specific immunoglobulin E (IgE) (defined as ≥class 2, ≥0.70 kU/l) against grass: Phleum pratense
- Positive skin prick test to Phleum pratense at screening
Exclusion
- Has a clinically relevant history of symptomatic seasonal and/or perennial allergic rhinoconjunctivitis and/or asthma caused by an allergen other than grass pollen, to which the subject is exposed, which could potentially overlap with the efficacy assessment periods
- Within the last 3 months before the randomisation visit, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
- SLIT treatment with any grass pollen AIT for more than 1 month within the last 5 years. In addition, any SLIT treatment with grass pollen AIT within the previous 12 months
- SCIT treatment with any grass AIT reaching the maintenance dose within the last 5 years. In addition, any SCIT treatment with grass AIT within the previous 12 months
- Ongoing treatment with any allergy immunotherapy product
- Uncontrolled or severe asthma requiring daily use of more than 800 mcg budesonide or equivalent at screening
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2023
Estimated Enrollment :
445 Patients enrolled
Trial Details
Trial ID
NCT04881461
Start Date
May 10 2021
End Date
September 26 2023
Last Update
December 16 2024
Active Locations (48)
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