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

NCT05126316 | Completed Phase 1

• 1 other identifier: 19424A
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Baseline (Day 1) up to Week 20

Secondary Outcomes (6)

• Area Under the Serum Concentration-Time Curve in the Last Dosing Interval (AUC0-τ) 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

• 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

Study Arms (3)

Lu AG09222 Low Dose

EXPERIMENTAL

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

Drug: Lu AG09222

Lu AG09222 High Dose

EXPERIMENTAL

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

Drug: Lu AG09222

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lu AG09222 DRUG

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

Lu AG09222 High Dose; Lu AG09222 Low Dose

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (2)

St Pancras Clinical Research

London, EC2Y 8EA, United Kingdom

Location

Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Email contact via H. Lundbeck A/S

  H. Lundbeck A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 19, 2021
• Study Start: November 1, 2021
• Primary Completion: July 12, 2022
• Study Completion: August 25, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

GB (2)