A Trial to Learn More About Repeated Monthly Injections of Lu AG09222 in Participants With Allergies to Grass Pollen
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Lu AG09222
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis
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.
Sites / Locations
- St Pancras Clinical Research
- Medicines Evaluation Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Lu AG09222 Low Dose
Lu AG09222 High Dose
Placebo
Arm Description
Participants will receive Lu AG09222 injection at a low dose level 3 times with 4 weeks between each administration.
Participants will receive Lu AG09222 injection at a high dose level 3 times with 4 weeks between each administration.
Participants will receive placebo matching to Lu AG09222 injection 3 times with 4 weeks between each administration.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
Secondary Outcome Measures
Area Under the Serum Concentration-Time Curve in the Last Dosing Interval (AUC0-τ) of Lu AG09222
Maximum Observed Concentration (Cmax) of Lu AG09222
Time to Maximum Observed Concentration (Tmax) of Lu AG09222
Apparent Elimination Half-Life of Lu AG09222
Change from Baseline to Week 8 in Wheal-Reaction Area at 20 and 120 Minutes After Allergen Challenge
Change from Baseline to Week 8 in Flare-Reaction Area at 20 and 120 Minutes After Allergen Challenge
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05126316
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
July 12, 2022 (Actual)
Study Completion Date
August 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lu AG09222 Low Dose
Arm Type
Experimental
Arm Description
Participants will receive Lu AG09222 injection at a low dose level 3 times with 4 weeks between each administration.
Arm Title
Lu AG09222 High Dose
Arm Type
Experimental
Arm Description
Participants will receive Lu AG09222 injection at a high dose level 3 times with 4 weeks between each administration.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matching to Lu AG09222 injection 3 times with 4 weeks between each administration.
Intervention Type
Drug
Intervention Name(s)
Lu AG09222
Intervention Description
Lu AG09222 will be administered per schedule specified in the arm description.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to Lu AG09222 will be administered per schedule specified in the arm description.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Time Frame
Baseline (Day 1) up to Week 20
Secondary Outcome Measure Information:
Title
Area Under the Serum Concentration-Time Curve in the Last Dosing Interval (AUC0-τ) of Lu AG09222
Time Frame
Up to 96 hours post last dose on Days 57 to 61; and on Days 64, 71, 78, and 84
Title
Maximum Observed Concentration (Cmax) of Lu AG09222
Time Frame
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
Title
Time to Maximum Observed Concentration (Tmax) of Lu AG09222
Time Frame
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
Title
Apparent Elimination Half-Life of Lu AG09222
Time Frame
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
Title
Change from Baseline to Week 8 in Wheal-Reaction Area at 20 and 120 Minutes After Allergen Challenge
Time Frame
Baseline, Week 8
Title
Change from Baseline to Week 8 in Flare-Reaction Area at 20 and 120 Minutes After Allergen Challenge
Time Frame
Baseline, Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
H. Lundbeck A/S
Official's Role
Study Director
Facility Information:
Facility Name
St Pancras Clinical Research
City
London
ZIP/Postal Code
EC2Y 8EA
Country
United Kingdom
Facility Name
Medicines Evaluation Unit
City
Manchester
ZIP/Postal Code
M23 9QZ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Trial to Learn More About Repeated Monthly Injections of Lu AG09222 in Participants With Allergies to Grass Pollen
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