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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-08-25

Brief Summary

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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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Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lu AG09222 Low Dose

Participants will receive Lu AG09222 injection at a low dose level 3 times with 4 weeks between each administration.

Group Type EXPERIMENTAL

Lu AG09222

Intervention Type DRUG

Lu AG09222 will be administered per schedule specified in the arm description.

Lu AG09222 High Dose

Participants will receive Lu AG09222 injection at a high dose level 3 times with 4 weeks between each administration.

Group Type EXPERIMENTAL

Lu AG09222

Intervention Type DRUG

Lu AG09222 will be administered per schedule specified in the arm description.

Placebo

Participants will receive placebo matching to Lu AG09222 injection 3 times with 4 weeks between each administration.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Lu AG09222

Lu AG09222 will be administered per schedule specified in the arm description.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No