Combined Phase 2b/3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis
Key Inclusion Criteria:
- Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit
- Documented diagnosis of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge. Documentation should include endoscopic and histopathologic evidence of UC.
- A surveillance colonoscopy is required at screening in individuals with a history of UC for 8 or more years, if one was not performed in the prior 24 months
- Moderately to severely active UC
- Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents: corticosteroids, immunomodulators, tumor necrosis factor alpha (TNFa) antagonists, or vedolizumab
- Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon
- Active tuberculosis (TB) or history of latent TB that has not been treated
- Use of any concomitant prohibited medications as described in the protocol
This is a Phase 2b/3, double-blind, placebo-controlled, randomized study. Double-blind means the patient and the study doctor will not know what study drug (active or not active) the patient will be taking. Placebo-controlled means that the patient may be taking a tablet with no medicine in it (not active) but the tablet looks like filgotinib. Whether or not the patient gets the drug or the placebo is randomly assigned. Patients will take the assigned drug for 10 weeks. Depending on the response to study drug after 10 weeks, the patient may be randomized to the take either active study drug or placebo in the maintenance study. Patients who are not responding well after 10 weeks may be eligible to receive active filgotinib in a long-term extension study. In addition, patients who complete the maintenance study may have the opportunity to participate in a long-term extension 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
- To be in this study, patients need to visit the clinic at least 13 times, not including the screening visits. Pregnancy tests will be required during the study for women who can get pregnant. The duration of participation for eligible patients will be approximately 1 year. The length between study visits may vary between 2 and 8 weeks.
- After informed consent is obtained, patients will be screened to confirm that they have met all inclusion/exclusion criteria for the study and a screening endoscopy with biopsy will be performed. Other screening procedures include: medical history, complete physical examination, chest X-ray, ECG, prior treatment for ulcerative colitis disease and blood, urine, and stool sample collection. Patients must follow strict birth control guidance during the study. During the treatment period, ECGs, blood and stool samples will be collected periodically for safety, efficacy, and exploratory assessments. A endoscopy will be performed at weeks 10 and 58 to assess if the drug is working.
- Patients will be required to keep an electronic diary beginning with the first screening 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, ECGs, and endoscopies (images of your bowel). 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. Endoscopy may require the use of medicines to clean your intestines, and rare complications such as infection and a hole in the colon may occur.
- You may be asked personal questions during the study to understand the effect the disease has on your life.