Clinical research studies are conducted to determine if investigational drugs are safe and if they work. Clinical research studies are performed according to government regulations that help protect the safety and rights of study participants.

The ISABELA clinical study program entails two identical designed studies: ISABELA 1 and ISABELA 2. The studies are intended to confirm each other’s results.

The studies consist of an up to 4-week screening period (to see whether patients qualify for participation), a treatment period of at least 52 weeks, and a follow up period of 4 weeks. At least 13 visits to the site are foreseen in these periods. Patient health will be monitored throughout the studies.

ISABELA 1 and 2 will be performed in multiple countries. Current list of planned countries:

• Argentina
• Australia
• Belgium
• Brazil
• Canada
• Chile
• Czech Republic
• Denmark
• France
• Germany
• Greece
• Hungary
• Israel
• Italy

• Japan
• Mexico
• Netherlands
• New Zealand
• Poland
• Peru
• South Africa
• South Korea
• Spain
• Taiwan
• Turkey
• United Kingdom
• United States of America

 

The studies will include over 200 study sites. In the Study Center Locator you will find active study centers in your region. Please make sure to check back at a later date in case you don’t see any active sites in your region yet. We do not know beforehand exactly when a center will be activated but the Study Center Locator will be updated regularly with most current information.

Patients with an established diagnosis of IPF (less than 5 years ago) may be able to participate, whether or not they are treated with pirfenidone or nintedanib. Patients need to be 40 years of age or older and should be able to come to the hospital for visits. A full check of all eligibility criteria will be performed by the study center.

Yes

No, participants will not be reimbursed for pirfenidone or nintedanib, the standard of care treatment.

No. All patients will continue on their current IPF care/treatment and will be randomly assigned to one of the three treatment groups, either one of the two doses of GLPG1690 or placebo for the duration of the study. 1 out of every 3 patients will receive placebo, which is a pill that looks like the study drug but is not active. The study will be blinded, which means that patients, caregivers, and physicians will not know whether the participant is receiving GLPG1690 or placebo.

Yes, there will be a 1 in 3 chance for patients to receive placebo in addition to their standard IPF care/treatment. Two thirds (2/3) of patients will receive GLPG1690 in addition to their standard IPF care/treatment, half of them on the 200 mg dose and half on the 600 mg dose, for the duration of the study.

Patients will receive the study drug for at least 52 weeks. Patients will remain on the study drug or placebo until the last patient in their respective study has completed 52 weeks. Therefore, some patients will continue in the study for a substantial period of time beyond 52 weeks.

Patients will be in the study for an up to 4-week screening period, a treatment period (please see the question above for more details about the treatment period), and a follow-up period of 4 weeks.

This study will continue until the last patient has reached week 52 in the study.

The primary goal is to establish the safety and efficacy of GLPG1690 as the treatment of IPF on top of standard of care. The primary endpoint is the rate of decline of Forced Vital Capacity (FVC, in mL) until week 52, which indicates lung function decline, assessed by spirometry.

In addition to safety, tolerability and efficacy, impact on quality of life will also be measured.

Galapagos NV is developing the investigational study drug GLPG1690 and will be sponsoring these clinical research studies.

During the study patients are requested to:

• Take the study medication as instructed by the study doctor
• Attend all scheduled study visits
• Answer questions about their health
• Complete lung function tests
• Provide urine and blood samples at study visits
• Follow all instructions from the study staff

GLPG1690 is an experimental drug which can be taken in tablet form by mouth. “Experimental” means that the study drug is currently under investigation and is not yet approved for any illness in any country by the Ministry of Health or other governmental institution.

It has been described that patients with IPF have increased levels of autotaxin. It is being investigated whether GLPG1690 can, by decreasing the activity of autotaxin, safely inhibit increased autotaxin levels in the lungs that occurs in people with IPF and therefore affect the progression of the disease.

For all additional questions about the ISABELA program, we have to refer you to your physician. He or she can get in touch with one of the active centres to discuss, if necessary.