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Evaluating Gradual Interval Extension of Tezepelumab in Drug Combination for Patients with Severe Asthma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Severe Asthma, a long‑term lung condition in which the airways become overly sensitive and narrowed, causing frequent shortness of breath, wheezing, and coughing. To treat this condition, the trial uses several approved biologic medicines that target specific parts of the immune system. The medicines include mepolizumab, reslizumab, dupilumab, benralizumab, and tezepelumab. These drugs are given as a small injection under the skin (subcutaneous injection).

The purpose of the study is to evaluate the safety and feasibility of gradually extending the dosing interval of these biologic therapies over roughly one year. Participants will receive one of the listed medicines at the regular interval used in routine care, and the interval may be lengthened step by step according to a predefined plan. Throughout the study, individuals will attend regular clinic visits where health status, breathing tests, blood samples, and questionnaire responses are collected.

Safety is monitored by checking for any worsening of symptoms, called an exacerbation, which means a sudden increase in asthma problems lasting more than two days. Blood tests look at the number of eosinophils, a type of white blood cell involved in inflammation, and at the level of exhaled nitric oxide (FeNO), a breath test that reflects airway inflammation. Lung function is measured with the amount of air expelled in the first second (FEV1) and the total amount expelled (FVC). Participants also complete the Asthma Control Questionnaire (ACQ) to rate how well their asthma is controlled, and a lab test called polymerase chain reaction (PCR) may be used to detect viruses during any worsening episodes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline assessment
asthma control is measured using the asthma control questionnaire (acq) and a clinical evaluation.
Blood is drawn to determine eosinophil count and feno level.
Lung function is tested with forced expiratory volume in 1 second (fev1) and forced vital capacity (fvc).
Questionnaires including the severe asthma questionnaire (saq) and sino‑nasal outcome test (snot‑22) are completed.
Step 2
First biologic injection
A subcutaneous injection of the assigned study drug is given.
Possible study drugs and their doses are:
nucala: 100 mg solution for injection in a pre‑filled pen.
cinqaero: 3 mg/kg (dose calculated per body weight) solution for infusion.
dupixent 200 mg: 200 mg solution for injection in a pre‑filled pen.
dupixent 300 mg: 300 mg solution for injection in a pre‑filled pen.
fasenra: 30 mg solution for injection in a pre‑filled pen.
tezspire: 210 mg solution for injection in a pre‑filled pen.
The injection is administered according to the study schedule, and the interval between doses may be gradually prolonged during the approximately one‑year trial.
Step 3
Regular follow‑up visits
At each visit the patient receives the next subcutaneous injection of the assigned biologic.
The interval between injections is reviewed and may be lengthened according to the study algorithm.
Asthma control is reassessed with the acq; a score lower than 2.0 indicates good control.
Blood samples are taken to monitor eosinophil count and feno.
Lung function tests (fev1, fvc, fev1/fvc) are repeated.
The saq and snot‑22 questionnaires are completed again.
The dosage of inhaled corticosteroids (ics) and inhaler technique are reviewed.
Step 4
Reporting exacerbations
Any worsening of asthma symptoms lasting more than 48 hours is reported as an exacerbation.
The study defines an exacerbation as an acute increase in symptoms that requires medical assessment.
Step 5
Final assessment
After approximately one year, a final visit is conducted.
The last biologic injection is given.
Asthma control, blood eosinophil count, feno, lung function, and questionnaire scores are measured one final time.
The primary outcome of maintained asthma control is evaluated based on exacerbation frequency and the final acq score.

Who can join the trial?

6 criteria

You must have been taking a biologic medication such as mepolizumab, reslizumab, benralizumab, dupilumab, or tezepelumab for at least 12 months. A biologic medication is a treatment made from living cells that targets specific parts of the immune system to help control asthma.
You must be 18 years old or older.
In the past 12 months you should have had no more than one asthma flare‑up (also called an exacerbation), which is a sudden worsening of symptoms that may need extra treatment.
Your starting score on the Asthma Control Questionnaire (ACQ) must be less than 2.0. The ACQ is a short survey that measures how well your asthma symptoms are controlled; lower scores mean better control.
Your blood test must show a low level of a type of white blood cell called eosinophils:
- ≤ 0.3 × 10⁹/L if you are using an anti‑IL‑5(R) drug (such as mepolizumab, reslizumab, or benralizumab) or tezepelumab.
- ≤ 1.5 × 10⁹/L if you are using dupilumab. Eosinophils are cells that can cause inflammation in the airways of people with asthma.

Who cannot join the trial?

5 criteria

Uncontrolled asthma (meaning you have had more than one exacerbation or flare‑up in the past 12 months, or your score on the Asthma Control Questionnaire (ACQ) is higher than 2.0, which shows the asthma is not well controlled).
Pregnancy (being pregnant at the time of the study).
Planning to become pregnant within the next 12 months.
Having already lengthened the dosing intervals of your biologic medication (a type of treatment made from living cells) beyond what is allowed in the official product information (SmPC) at your own request.
Inability to understand or communicate in Dutch or English, both spoken and written.

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Amsterdam UMC
Amsterdam, The Netherlands

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Investigated drugs

Nucala
is a biologic medicine that works by lowering the number of certain white blood cells called eosinophils, which can cause inflammation and make asthma symptoms worse. In this study, patients receive Nucala by a small injection under the skin, and the researchers are testing whether the time between each injection can be safely lengthened over about a year.
Cinqaero
is a biologic treatment that blocks a protein called interleukin‑5, helping to reduce eosinophils and the inflammation they cause in severe asthma. It is given as an injection under the skin, and the trial examines if the interval between doses can be gradually extended while keeping the asthma well‑controlled.
Dupixent
is a biologic drug that blocks two key signals, interleukin‑4 and interleukin‑13, which are involved in airway inflammation in asthma. Patients receive Dupixent by a pre‑filled pen injection under the skin, and the study looks at whether the spacing between injections can be safely increased over time.
Fasenra
is a biologic therapy that targets the receptor for interleukin‑5 on eosinophils, leading to a rapid decrease in these cells and less airway inflammation. It is administered as a subcutaneous injection, and the trial aims to see if patients can safely go longer between each dose.
Tezspire
is a biologic medication that blocks a molecule called thymic stromal lymphopoietin (TSLP), which helps reduce overall airway inflammation in severe asthma. Given by injection under the skin, the study evaluates whether the interval between Tezspire doses can be gradually prolonged while maintaining safety and effectiveness.

What is already known about the treatment

Nucala
This medication is given as a 100 mg solution for subcutaneous injection using a pre‑filled pen. It is an approved biologic used mainly for severe eosinophilic asthma and is listed in current medical literature. It works by attaching to the protein interleukin‑5 (IL‑5) and stopping IL‑5 from activating eosinophils, which reduces airway inflammation. It belongs to the class of humanized monoclonal antibodies that target IL‑5.
Cinqaero
Cinqaero is supplied as a 3 mg/kg solution for subcutaneous injection in a vial for infusion. The drug is approved for severe eosinophilic asthma and is well documented in recent clinical studies. It binds to interleukin‑5, preventing this cytokine from stimulating eosinophils, thereby lowering inflammation in the lungs. It is classified as a humanized monoclonal antibody against IL‑5.
Dupixent
Dupixent is a 200 mg or 300 mg solution for subcutaneous injection delivered with a pre‑filled pen. It is an authorized treatment for severe asthma as well as several skin conditions, and it is widely referenced in the medical literature. The drug blocks the interleukin‑4 receptor alpha, which stops both IL‑4 and IL‑13 signals that drive allergic inflammation. It is a fully human monoclonal antibody classified as an anti‑IL‑4R agent.
Fasenra
Fasenra comes as a 30 mg solution for subcutaneous injection in a ready‑to‑use pen. It has regulatory approval for severe eosinophilic asthma and is frequently cited in recent research. The medication attaches to the IL‑5 receptor on eosinophils, marking them for destruction by immune cells and thus reducing airway inflammation. It is an afucosylated humanized monoclonal antibody that targets the IL‑5 receptor.
Tezspire
Tezspire is provided as a 210 mg solution for subcutaneous injection in a pre‑filled pen. It is an approved biologic for severe asthma and is featured in current clinical guidelines. It works by binding to thymic stromal lymphopoietin (TSLP), an early‑acting cytokine that triggers many inflammatory pathways in the airway. This drug belongs to the class of human monoclonal antibodies that target TSLP.

Investigated diseases

Severe asthma - Severe asthma is a form of asthma where symptoms are frequent and difficult to control with standard inhaled medicines. People experience regular shortness of breath, wheezing, and coughing that interfere with daily activities. The condition often includes episodes of worsening breathing that last more than two days. Over time, the airways may become increasingly narrow, leading to reduced ability to exhale quickly.