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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

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

NCT ID

NCT05126316

First Posted

November 8, 2021

Last Updated

October 25, 2022

Sponsor

H. Lundbeck A/S

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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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