A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis
The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in ulcerative colitis (UC).
Key Inclusion Criteria:
- Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial
- Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for UC
- Females of childbearing potential must have a negative pregnancy test at Day 1
- Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the protocol for the duration described
- Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
Key Exclusion Criteria:
- Known hypersensitivity to the study drug
- Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator, would make the subject unsuitable for the study or would prevent compliance with the study protocol
- Males or females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the participants
- Use of prohibited medications as outlined in the protocol
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
This is a long-term extension study. Patients who have completed or did not respond well to study treatment in the prior Gilead study may eligible participate in the study. The dose received in this study will vary and depends on what happened in the prior Gilead study.
Description of Treatment or Intervention (Mechanism of Action)
Mechanism of Action: Filgotinib is an oral investigational drug called a “JAK1 inhibitor” that is taken as a pill once a day. JAK1 inhibitors may slow damage to the digestive system by slowing down the activity of immune cells.
Patient Participation Requirements
- Eligible patients will have at least 15 site visits. Pregnancy testing will be required through the study. The duration of participation for eligible patients will be up to 144 weeks. The length between visits could be between 2 and 12 weeks.
- The first study visit may happen on the same day as the last study visit in the previous filgotinib study. After obtaining informed consent, patients will be required to meet all inclusion/exclusion criteria for the study. Patients must follow strict birth control guidance during the study. During the treatment period, ECGs, blood and stool samples will be collected periodically. Patients who complete the study will need to return for a follow-up visit.
- Patients will be required to keep an electronic diary beginning with the first study visit and ending at the final study visit. Patients will record information daily on their stool frequency and rectal bleeding."
Possible Risks & Side Effects
- The study involves taking an investigational (experimental) drug. Since the drug is investigational, there may be risks that are not yet identified. The investigational drug affects the immune system, and may weaken the body’s ability to fight off infection. A possible risk of being in the study is an increased risk of infection. Infections have been reported in previous studies of this drug.
- Some side effects have been seen in people who have taken this study drug before. Across different studies of this study drug in different types of patients, some of the more common side effects include headache, sleepiness and fatigue, nausea, upper abdominal discomfort, and abnormal taste in mouth.
- At this time, the effect of the study drug on pregnancy is not known. Strict use of birth control must be followed for both men and women.
- With any drug there is a risk of allergic reaction, which can range from mild (such as itching) to serious (such as problems breathing).
- The study requires blood draws, stool samples, and ECGs. Collecting a blood sample from a vein may cause pain, bruising, lightheadedness, fainting, and very rarely, infection or injury to the nerves at the site of the needle stick. After you have an ECG, you may have mild irritation, slight redness, and itching on your skin where the recording patches are attached.
- You may be asked personal questions during the study to understand the effect the disease has on your life.