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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AG09222 Low Dose | Experimental | Participants will receive Lu AG09222 injection at a low dose level 3 times with 4 weeks between each administration. |
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| Lu AG09222 High Dose | Experimental | Participants will receive Lu AG09222 injection at a high dose level 3 times with 4 weeks between each administration. |
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| Placebo | Placebo Comparator | Participants will receive placebo matching to Lu AG09222 injection 3 times with 4 weeks between each administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG09222 | Drug | Lu AG09222 will be administered per schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Baseline (Day 1) up to Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Concentration-Time Curve in the Last Dosing Interval (AUC0-Ï„) of Lu AG09222 | Up to 96 hours post last dose on Days 57 to 61; and on Days 64, 71, 78, and 84 | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | H. Lundbeck A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Pancras Clinical Research | London | EC2Y 8EA | United Kingdom | |||
| Medicines Evaluation Unit |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| Placebo | Drug | Placebo matching to Lu AG09222 will be administered per schedule specified in the arm description. |
|
| 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 |
| 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 |
| 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 |
| Manchester |
| M23 9QZ |
| United Kingdom |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |