A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis (Rhapsody)

ALK-Abelló

Status and phase: Completed; Phase 3

Conditions: Allergy

Treatments: Drug: Placebo; Drug: 5-grass mix SLIT-drops

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04881461

SU-G-01

2020-000455-12 (EudraCT Number)

Details and patient eligibility

About

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 second grass pollen season (peak grass pollen season, PGPS)

The study will collect health-related quality of life data in the groups treated with 5-grass mix SLIT-drops or with placebo during the first and second PGPS.

The trial medication used is already approved to treat allergic rhinitis caused by grass pollen in adults in several countries.

Full 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 rhinoconjunctivitis with or without asthma. Approximately 440 adults will be enrolled in the trial and will receive the 5-grass mix SLIT-drops or placebo. The trial is conducted in several European countries.

Enrollment: 445 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female aged ≥18 years on the day informed consent is obtained
2. A clinical history of grass pollen-induced allergic rhinoconjunctivitis for two years or more with or without asthma
3. 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
4. Positive specific immunoglobulin E (IgE) (defined as ≥class 2, ≥0.70 kU/l) against grass: Phleum pratense
5. Positive skin prick test to Phleum pratense at screening

Exclusion criteria

1. 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
2. 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
3. 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
4. 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
5. Ongoing treatment with any allergy immunotherapy product
6. Uncontrolled or severe asthma requiring daily use of more than 800 mcg budesonide or equivalent at screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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445 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Glycerol, carbonate, sodium chloride One single-dose container (0.5 ml) once daily

Treatment:

Drug: Placebo

5-grass mix SLIT-drops

Experimental group

Description:

Grass mix sublingual allergy immunotherapy drops One single-dose container (0.5 ml) once daily. 50 SRU/day for five consecutive days followed by 150 SRU/day for five additional consecutive days. Maintenance: 300 SRU/day from day 11.

Treatment:

Drug: 5-grass mix SLIT-drops