A Trial to Learn More About Repeated Monthly Injections of Lu AG09222 in Participants With Allergies to Grass Pollen

Allergic Rhinitis Clinical Trial

Official title:

Multiple-dose Safety, Pharmacokinetic and Pharmacodynamic Trial, in Subjects With Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05126316
• Other study ID #: 19424A
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

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