asked questions

1. What is a clinical research study?

Clinical research studies are studies conducted for the purposes of testing the safety and effectiveness of investigational drugs and involve the participation of people who volunteer.

Clinical research studies involve observing the patients who have volunteered to participate for a period of time in order to test the effectiveness of the drug as well as to monitor any side-effects.

Clinical research studies are performed according to strict governmental and ethical guidelines that ensure patients’ rights are protected. Clinical research studies and investigational drugs go through many stages of approval before they are open to the public, and play a pivotal role in the advancement of medicine.

2. What is this study about?

Sarcoidosis is a systemic disease of unknown etiology that is characterized by the formation of granulomas (cluster of inflammatory cells) in various organs, mainly the lungs and lymphatic system. Over 90% of sarcoidosis patients develop pulmonary sarcoidosis manifested by granuloma formation in the lungs.

Currently available therapies for sarcoidosis aim to slow down the granuloma formation, ameliorate symptoms, and preserve organ function. These therapies, in particular corticosteroids and immunosuppressants, are often associated with serious, long-term side effects which restrict their effectiveness. Currently, there is no specific cure for sarcoidosis and effective and safe therapy remains an unmet medical need. Thus researchers are exploring alternative treatments such as the one proposed in this study.

The study will test an experimental medicine, for the first time in patients with pulmonary sarcoidosis. The study goal is to evaluate this experimental medicine in the reduction of inflammation and assessing its safety.

Patients who enrol in the study will be randomly assigned to receive either the experimental medicine or a placebo. A placebo looks like the experimental medicine, but it won’t have any effect on the person who gets it.

3. How long does the study last?

The total duration of the study is 20 weeks.

Eligible patients will need to complete 6-7 on-site visits and 3-4 tele-health visits.

Each patient is expected to complete the study, attending all scheduled onsite and follow-up visits.

Your expenses for travels and meals will be reimbursed.

4. How does this study work?

The study will be conducted in hospitals or outpatient clinics by medical staff. Eligible patients will be asked to come to the hospital or the clinic at very precise times that are called ‘study visits’ (6-7 on-site visits and 3-4 tele-health visits). For all patients there will be a screening period, a treatment period which last for 12 weeks and then a follow up visit approximately 4 weeks post last dose. The total duration of the study is 20 weeks.

5. Can I withdraw from the study?

Yes, volunteers are free to withdraw at any time without any effect on your legal rights or the standard of care you receive.