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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05126316
Other study ID # 19424A
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 1, 2021
Est. completion date August 25, 2022

Study information

Verified date October 2022
Source H. Lundbeck A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 25, 2022
Est. primary completion date July 12, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lu AG09222
Lu AG09222 will be administered per schedule specified in the arm description.
Placebo
Placebo matching to Lu AG09222 will be administered per schedule specified in the arm description.

Locations

Country Name City State
United Kingdom St Pancras Clinical Research London
United Kingdom Medicines Evaluation Unit Manchester

Sponsors (1)

Lead Sponsor Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events Baseline (Day 1) up to Week 20
Secondary Area Under the Serum Concentration-Time Curve in the Last Dosing Interval (AUC0-t) of Lu AG09222 Up to 96 hours post last dose on Days 57 to 61; and on Days 64, 71, 78, and 84
Secondary 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
Secondary 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
Secondary 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
Secondary Change from Baseline to Week 8 in Wheal-Reaction Area at 20 and 120 Minutes After Allergen Challenge Baseline, Week 8
Secondary Change from Baseline to Week 8 in Flare-Reaction Area at 20 and 120 Minutes After Allergen Challenge Baseline, Week 8
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