Clinical trial NCT05126316: A Trial to Learn More About Repeated Monthly Injections of Lu AG09222 in Participants With Allergies to Grass Pollen
Official title: Multiple-dose Safety, Pharmacokinetic and Pharmacodynamic Trial, in Subjects With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergic Rhinitis
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2021-11-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Baseline (Day 1) up to Week 20
Secondary outcomes:
measure: Area Under the Serum Concentration-Time Curve in the Last Dosing Interval (AUC0-τ) of Lu AG09222
timeFrame: Up to 96 hours post last dose on Days 57 to 61; and on Days 64, 71, 78, and 84
measure: Maximum Observed Concentration (Cmax) of Lu AG09222
timeFrame: 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
measure: Time to Maximum Observed Concentration (Tmax) of Lu AG09222
timeFrame: 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
measure: Apparent Elimination Half-Life of Lu AG09222
timeFrame: 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
measure: Change from Baseline to Week 8 in Wheal-Reaction Area at 20 and 120 Minutes After Allergen Challenge
timeFrame: Baseline, Week 8
measure: Change from Baseline to Week 8 in Flare-Reaction Area at 20 and 120 Minutes After Allergen Challenge
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Pancras Clinical Research
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit
Study officials:
affiliation: H. Lundbeck A/S
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: