Allergic Rhinitis
Conditions
Brief summary
The main goal of this trial is to learn more about the safety of repeated dosing with Lu AG09222. The trial doctors will keep track of the participant's overall health by asking them how they are and by analyzing blood and urine samples.
Interventions
DRUGLu AG09222
Lu AG09222 will be administered per schedule specified in the arm description.
DRUGPlacebo
Placebo matching to Lu AG09222 will be administered per schedule specified in the arm description.
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* The participant has a body mass index (BMI) ≥18.0 and ≤30 kilograms (kg)/square meter (m\^2) at the screening visit. * The participant has a clinical history of grass pollen allergic rhinitis of at least 2 years' duration as diagnosed by a physician. * The participant has a positive specific immunoglobulin E (IgE) (defined as ≥class 2, ≥0.70 kilounits \[kU\]/liter \[L\]) against Phleum pratense at screening. * The participant has a positive skin prick test with a wheal size ≥3 mm to Phleum pratense at screening. * The participant is, in the opinion of the investigator, generally healthy based on medical history (despite the allergic rhinitis), a physical examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
Exclusion criteria
* The participant has received sublingual or subcutaneous immunotherapy with Phleum pratense within the last 5 years. * The participant is receiving ongoing treatment with any allergy immunotherapy product. * The participant has a clinically relevant history of symptomatic (seasonal or perennial) allergy caused by an allergen source overlapping with the allergen challenge period. * The participant has taken disallowed medication or received a COVID-19 vaccination within the protocol-specified amount of time before Day 1. * The participant has a relevant history of systemic allergic reaction, for example anaphylaxis with cardiorespiratory symptoms, generalized urticaria, or severe facial angioedema, which in the opinion of the investigator may constitute an increased safety concern. Other inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events | Baseline (Day 1) up to Week 20 |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Observed Concentration (Cmax) of Lu AG09222 | Predose on Days 1 and 57; up to 96 hours post last dose on Days 57 to 61; and on Days 64, 71, 78, and 84 |
| Time to Maximum Observed Concentration (Tmax) of Lu AG09222 | Predose on Days 1 and 57; up to 96 hours post last dose on Days 57 to 61; and on Days 64, 71, 78, and 84 |
| Area Under the Serum Concentration-Time Curve in the Last Dosing Interval (AUC0-τ) of Lu AG09222 | Up to 96 hours post last dose on Days 57 to 61; and on Days 64, 71, 78, and 84 |
| Change from Baseline to Week 8 in Wheal-Reaction Area at 20 and 120 Minutes After Allergen Challenge | Baseline, Week 8 |
| Change from Baseline to Week 8 in Flare-Reaction Area at 20 and 120 Minutes After Allergen Challenge | Baseline, Week 8 |
| Apparent Elimination Half-Life of Lu AG09222 | Predose on Days 1 and 57; up to 96 hours post last dose on Days 57 to 61; and on Days 64, 71, 78, and 84 |
Countries
United Kingdom
Outcome results
None listed