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Active not recruitingPHASE2INTERVENTIONAL

Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study

This research study is investigating a new medication called amlitelimab for adults suffering from moderate to severe asthma. Participants will have already been part of a previous amlitelimab asthma study. The main goal is to understand how safe and effective amlitelimab is over a longer period. For the first 24 weeks, neither you nor your doctor will know if you're receiving amlitelimab or a dummy treatment (placebo). After this, everyone will receive amlitelimab openly. The study will monitor your health and asthma symptoms for up to 156 weeks, offering valuable insights into managing your condition.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Sanofi
Enrolment target
335
Start
05 Sep 2023
Estimated completion
29 Sep 2026

What is this study about?

This study is about a medication called amlitelimab for adults who have moderate to severe asthma. If you're reading this, it's because you've likely participated in an earlier study for amlitelimab. The purpose now is to see how well amlitelimab works and if it's safe to use over a longer time, helping us understand its potential to manage asthma in the long run.

Initially, for the first 24 weeks, the study is 'double-blind.' This means that neither you nor the study team will know if you are receiving amlitelimab or a placebo (an inactive substance that looks like the study drug). This method helps ensure the results are as fair and unbiased as possible. After this first period, everyone in the study will then receive amlitelimab openly, meaning both you and the care team will know you are getting the active medication.

Understanding the long-term effects of any new treatment is very important. This study will gather information on how amlitelimab affects your asthma symptoms, your general well-being, and any side effects you might experience over an extended period, which could be up to 156 weeks. This detailed information will help doctors understand if amlitelimab can be a helpful and safe option for people living with ongoing asthma.

Key takeaways

  • This study evaluates amlitelimab's long-term safety and effectiveness for moderate to severe asthma.
  • It's for adults aged 18-75 who completed a previous amlitelimab asthma study.
  • The study lasts up to 156 weeks, with 18 planned clinic visits.
  • Initially, it's a double-blind study (you might get amlitelimab or a placebo), then everyone receives amlitelimab.
  • You must already be on specific regular asthma medications to qualify.
  • You can withdraw at any time without affecting your standard medical care.

Who may be eligible?

This study is specifically for adults aged 18 to 75 who have moderate to severe asthma and have already completed a previous study involving amlitelimab. You'll need to be on specific asthma medications consistently, such as certain doses of inhaled steroid treatments along with other regular asthma controllers like LABA, LTRA, LAMA, or methylxanthines. You might also be taking oral steroids, up to a certain limit.

There are also important health considerations. You won't be able to join if you have another long-term lung condition apart from asthma, or if your health has significantly changed since the previous study. Current smoking or vaping, or issues with substance abuse, would also prevent you from participating. Your doctor will carefully review your overall health to make sure joining the study is safe for you.

For women, you cannot be pregnant or breastfeeding, and must not plan to become pregnant. Both men and women will need to use effective contraception if there's any chance of becoming pregnant during the study. If you have any allergies that the study doctor believes might be a risk, you would also not be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am between 18 and 75 years old.
  2. I have moderate-to-severe asthma and have previously been in an amlitelimab study.
  3. I am currently taking specific prescribed asthma inhalers and/or other controllers.
  4. I do not have another long-term lung condition apart from asthma.
  5. I am not currently smoking or vaping, or misusing substances.
  6. For women, I am not pregnant or breastfeeding, and will use effective contraception.
Answer every question to see your result.

What does participation involve?

If you decide to participate, the study will last for up to 156 weeks (about three years), with the treatment itself lasting up to 144 weeks. During this time, you will have a total of 18 visits to the clinic. For the first 24 weeks, you will either receive amlitelimab or a placebo. After this initial period, all participants will receive amlitelimab openly. Throughout the study, the research team will regularly check your asthma symptoms, overall health, and any side effects. This will involve various assessments and tests to monitor the medication's effects and ensure your safety.

Potential risks and benefits

Participating in this study could potentially offer benefits, such as receiving a new treatment for your asthma that might help manage your symptoms more effectively. However, as with any medication, there are potential risks, including side effects from amlitelimab or even from the placebo. All study treatments will be carefully monitored, and you will receive regular medical attention. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (68)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Bensch Research Associates- Site Number : 8400004
    Verified postcode
    Stockton, United States
  • Helix Biomedics- Site Number : 8400029
    Verified postcode
    Boynton Beach, United States
  • Savin Medical Group - Miami Lakes- Site Number : 8400015
    Verified postcode
    Miami Lakes, United States
  • Pines Care Research Center- Site Number : 8400028
    Verified postcode
    Pembroke Pines, United States
  • Treasure Valley Medical Research- Site Number : 8400031
    Verified postcode
    Boise, United States
  • Johns Hopkins Bayview Medical Center- Site Number : 8400012
    Verified postcode
    Baltimore, United States
  • OK Clinical Research- Site Number : 8400001
    Verified postcode
    Edmond, United States
  • South Texas Medical Research Institute - TTS Research- Site Number : 8400011
    Verified postcode
    Boerne, United States
  • Investigational Site Number : 0320008
    Verified postcode
    La Plata, Argentina
  • Investigational Site Number : 0320005
    Verified postcode
    Rosario, Argentina
  • Investigational Site Number : 0320006
    Verified postcode
    Rosario, Argentina
  • Investigational Site Number : 0320007
    Verified postcode
    Rosario, Argentina

Common questions

What is amlitelimab?

Amlitelimab is a study medication being investigated for treating moderate to severe asthma. This study is looking at its long-term safety and how well it works.

Why is this study only for people who have been in a previous amlitelimab study?

This particular study is designed to follow up on participants from earlier trials to understand the long-term effects of amlitelimab, building on previous safety and effectiveness information.

What is a 'double-blind' study?

In a double-blind study, neither you nor your study doctor will know if you are receiving the active medication (amlitelimab) or a dummy treatment (placebo) for the first part of the study. This helps ensure the study results are fair.

How long will I need to be in the study?

The study will last for up to 156 weeks, which is about three years. You will have 18 visits to the clinic during this time.

Can I stop participating if I want to?

Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your normal medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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