Still unable to manage asthma despite current medications?
This research trial might be right for you.
Why should I join this trial?
While most patients are already receiving treatment, millions still experience asthma attacks and have uncontrolled asthma.
This clinical trial is looking to assess an investigational biologic treatment administered using an inhaler.
CSJ117 may be added on to traditional medium- or high-dose prescribed inhalers in order to control severe asthma.
Biologics are medications that are developed from living organisms. They are used to treat a broad range of diseases and have been proven effective for severe asthma.
Most biologics used to treat asthma are injections, but this study drug is a biologic treatment that is taken with an inhaler.
What is severe asthma?
Asthma is a chronic or long-term disease that inflames and narrows the airways of lungs, making it difficult to breathe.1
Severe asthma refers to asthma that does not respond to regular treatments such as medium- or high-dose prescribed inhalers, the most frequently used treatments currently available. These may also be referred to as inhaled corticosteroids (ICS) and long-acting beta-2 antagonists (LABA).2
Common signs and symptoms of severe asthma include1:
- Wheezing (a high-pitched whistling sound) when breathing
- Shortness of breath
- Tightness of chest
- Coughing
- Frequent use of rescue (quick relief) inhaler
If you experience any of these symptoms, you may be eligible for this clinical trial.
Trial Summary
Condition: Asthma
Phase: 2
Sexes eligible for study: All
Ages eligible for study: 18 years to 75 years
Estimated enrollment: 625 participants
Recruitment status: Open for recruitment
What type of treatment will you get during the trial?
If you qualify and decide to participate, you will receive regular treatment (traditional prescribed inhalers) and the assigned study medication or placebo.
All study medications will be provided at no cost. This includes the assigned study medication or placebo, medium- or high-dose ICS/LABA, and rescue medication.
Participation in this clinical trial is voluntary.
What to expect during the study
The study will be conducted in 4 parts:
Up to 2 weeks
1 visit
The screening process will determine if you meet the requirements to participate. The study office will check your current baseline asthma severity and symptoms based on your current asthma treatments when entering the study.
4 weeks
2 visits, 1 call
This period will be used to ensure all study participants are using treatments as intended and remaining compliant. It will also track baseline health measures, which will be used as a comparison to the measures observed during the treatment phase. Patients will be asked to replace their current treatment with a standardized medium- or high-dose ICS inhaler.
12 weeks
4 visits
Treatment will last 12 weeks. All participants take study medication at home daily and have exams to evaluate changes in spirometry and symptoms compared to baseline.
12 weeks
4 visits
The follow up period will also last 12 weeks. You will have a few follow-up visits with your doctor from the study to record any final health measures after ceasing CSJ117 treatment.
The first step to see if you meet the study volunteer requirements is to take the pre-screener questionnaire.
Requirements for participating
If you are interested in participating in this study, see if you fit the selected criteria below. If these apply to you, you can take our screener questionnaire and a member of the research study staff may reach out to you to discuss your participation.
To qualify for this research study, you must meet the following requirements:
- Have a current diagnosis, from a doctor, of asthma
- Are a male or female 18 to 75 years of age
- Have been treated with medium- or high-dose inhaled corticosteroid (ICS) plus long-acting beta antagonist (LABA) with up to 2 additional controllers
- Have a history of at least one asthma attack in the past year that required immediate medical attention (emergency room visits) and treatment with systemic steroids
If you meet any of the following criteria, you will not be eligible for this study:
- Current smokers or past heavy smokers (defined as approximately 1 pack a day for 10 or more years)
- Women who are pregnant or nursing (lactating)
- Women who are capable of becoming pregnant and are not using specified methods of birth control. You cannot get pregnant while participating in this study. Approved birth control must be used during the dosing of study drug and one week after last study drug treatment
- Adults with a history of diseases that can lower immunity, like hepatitis B or hepatitis C, or HIV