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OpenTrials
Completed

NCT Number: NCT05126316

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St Pancras Clinical Research, London, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lu AG09222

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: Baseline (Day 1) up to Week 20

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Change from Baseline to Week 8 in Wheal-Reaction Area at 20 and 120 Minutes After Allergen Challenge

    Time frame: Baseline, Week 8

  6. Change from Baseline to Week 8 in Flare-Reaction Area at 20 and 120 Minutes After Allergen Challenge

    Time frame: Baseline, Week 8

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Multiple-dose Safety, Pharmacokinetic and Pharmacodynamic Trial, in Subjects With Allergic Rhinitis

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 19, 2021
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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