Study on Long-Term Safety and Efficacy of Amlitelimab for Adults with Moderate to Severe Asthma

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What is this study about?

This clinical trial is focused on studying asthma, a condition that affects the airways in the lungs, making it difficult to breathe. The study will use a treatment called amlitelimab, which is a solution for injection. Amlitelimab is a novel human anti-OX40L monoclonal antibody, which is a type of protein designed to help manage asthma symptoms. The study will also include a matched placebo for comparison purposes.

The purpose of this study is to evaluate the long-term safety and effectiveness of amlitelimab in adults with moderate to severe asthma who have already completed a previous amlitelimab asthma study. Participants will receive the treatment through subcutaneous injections, which means the medication is injected under the skin. The study will monitor participants over an extended period to assess how well they tolerate the treatment and its impact on their asthma symptoms.

Throughout the study, researchers will keep track of any side effects or adverse events that participants may experience. They will also measure changes in lung function and asthma control to determine the treatment’s effectiveness. This information will help in understanding how amlitelimab can be used to manage asthma in the long term.

1 joining the study

Upon joining the study, participants will be informed about the purpose and procedures of the trial. This study aims to evaluate the long-term safety and effectiveness of a medication called amlitelimab for individuals with moderate-to-severe asthma.

2 medication administration

Participants will receive amlitelimab through a subcutaneous injection, which means the medication is injected under the skin. The specific dosage and frequency of administration will be determined by the study protocol and communicated to participants by the study team.

3 ongoing asthma treatment

Participants will continue their existing asthma treatment, which includes medium-to-high doses of inhaled corticosteroids (ICS) such as fluticasone propionate, in combination with other asthma control medications. These may include long-acting beta agonists (LABA), leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA), or methylxanthines. Some participants may also use oral corticosteroids (OCS) as part of their treatment.

4 safety and health monitoring

Throughout the study, participants will be regularly monitored for any side effects or health changes. This includes tracking any adverse events that occur during the treatment period. Participants will be asked to report any new or unusual symptoms to the study team.

5 asthma control assessment

Participants will undergo regular assessments to evaluate their asthma control. This may include tests to measure lung function, such as spirometry, and completing questionnaires about asthma symptoms and quality of life.

6 study duration

The study is expected to continue until October 2030. Participants will be informed about the specific duration of their involvement in the study and any follow-up visits required after the treatment period.

Who Can Join the Study?

Participants must have moderate-to-severe asthma and have completed the treatment period of the previous study as required.
Participants must be taking a background dose of medium-to-high doses of inhaled corticosteroids (ICS). This means at least 500 micrograms of fluticasone propionate daily or a similar dose, up to a maximum of 2000 micrograms per day, along with a second or third controller medication. These controller medications can include:
- LABA (long-acting beta agonists)
- LTRA (leukotriene receptor antagonists)
- LAMA (long-acting muscarinic antagonists)
- Methylxanthines
Participants may also be taking oral corticosteroids (OCS) up to a maximum of 15 mg of prednisone or an equivalent dose daily, or 30 mg every other day, as maintained during the previous study. Note for participants in Japan: they must be on at least 400 micrograms of fluticasone propionate daily or an equivalent dose.
Participants must agree to use contraception:
- For female participants: They must be incapable of becoming pregnant, not pregnant or breastfeeding, and must not donate or preserve eggs.
- For male participants: They must not donate or preserve sperm.

Who Cannot Join the Study?

Participants with any other serious health conditions that could interfere with the study.
Participants who have had a recent infection that required treatment with antibiotics.
Participants who have been diagnosed with cancer in the past five years.
Participants who are currently pregnant or breastfeeding.
Participants who have a history of severe allergic reactions.
Participants who are currently using other medications that might interfere with the study treatment.
Participants who have participated in another clinical trial within the last 30 days.
Participants who have a history of drug or alcohol abuse.
Participants who have a known sensitivity or allergy to the study medication.
Participants who have a condition that affects their immune system, which is the body’s defense against infections.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Diamond Clinic Sp. z o.o.	Cracow	Poland
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Allergo-Fot Kft.	Szazhalombatta	Hungary
Koch Robert Korhaz Es Rendelointezet	Edeleny	Hungary
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.	Tarnow	Poland
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Alergologia Plus Sp. z o.o.	Poznan	Poland
Centrum Medycyny Oddechowej Mroz Sp. j.	Bialystok	Poland
Erzsebet Gondozohaz Kft.	Godollo	Hungary
Clinica Vitae Sp. z o.o.	Gdansk	Poland
Cucmdvw Brtbl Kygkeqvxavu Aazpwzfxx Mxqva	Elblag	Poland
Pbznsamjqflyjjz Euqkjshdfwcmw Saizlysqntx Ishycuacj	Puspokladany	Hungary

Trial status

Country	Status	Recruitment Start
Hungary	Not recruiting	10.03.2024
Italy	Not recruiting	10.03.2024
Poland	Not recruiting	10.03.2024

Trial locations

Investigated drugs:

Amlitelimab

Amlitelimab is a medication being studied for its potential to help people with moderate-to-severe asthma. It is given as an injection under the skin. The main goal of using amlitelimab in this study is to see if it is safe and well-tolerated when used for a long time. Researchers also want to find out if it can effectively help manage asthma symptoms over an extended period. Participants in this study have already completed a previous study with amlitelimab, and this trial aims to continue monitoring its effects on their asthma.

Investigated diseases:

Asthma

Asthma – Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. It often presents with symptoms such as wheezing, coughing, shortness of breath, and chest tightness. The disease can progress with episodes known as asthma attacks, where symptoms become more severe and require immediate attention. These attacks can be triggered by various factors, including allergens, exercise, cold air, or stress. Over time, asthma can lead to changes in the airways, making them more sensitive and reactive. The condition requires ongoing management to control symptoms and prevent exacerbations.

Trial ID:

2023-503385-24-00

Protocol code:

LTS17510

NCT ID:

NCT06033833

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Long-Term Safety and Efficacy of Amlitelimab for Adults with Moderate to Severe Asthma

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