A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate GB004 In Adult Subjects with Mild-To-Moderate Active Ulcerative Colitis. (SHIFT-UC Study)
Primary Objective: To Evaluate the Effect of GB004 Compared to Placebo on Clinical Remission
Inclusion Criteria include:
- Adult (18+) with active mild to moderate ulcerative colitis
- You have been diagnosed with ulcerative colitis for at least 3 months
- You are currently receiving treatment for UC, with oral 5-ASA (eg, mesalamine, sulfasalazine) alone or with one of the following oral treatments:
- a. Prednisone ≤ 20 mg/day or equivalent OR
- b. Budesonide or Budesonide multi-matrix (MMX) of ≤ 9 mg/day
Exclusion criteria includes:
- Prior treatment with any biologic therapy used for the treatment of UC
The SHIFT-UC Study will help evaluate the safety, tolerability, and biological activity of the investigational study drug, GB004, in patients with mild to moderate active Ulcerative Colitis (UC).
- The SHIFT-UC Study has been divided into four periods:
- Screening Period (up to about 5 weeks): Tests will be performed to determine if you can enroll in the study and adjustments may be made to current medications.
- Dosing Period: (Placebo controlled) (up to 36 weeks): You will be randomly assigned to study treatment with either the investigational study drug (GB004), placebo (a substance that looks like the study drug, but has no active ingredients), or a combination of the study drug and placebo (GB004 + placebo). This means you have a 66% chance of receiving active study drug vs. placebo. At week 12 your ulcerative colitis disease activity will be checked,
- If your UC has improved based on the UC disease activity criteria , you will remain on the current assignment for up to an additional 24 weeks (36 weeks in total), with an opportunity to move into the open-label period if your UC meets disease worsening criteria, or when you complete the 36 week placebo controlled period;
- If your UC has not improved based on the UC disease activity criteria, you will move into the open label period
- Dosing Period: (Open Label): (up to 24 weeks): You will move into this period after completing the main Dosing Period and be assigned to the investigational study drug (GB004).
- Follow-Up Period (4 weeks): One last visit 4 weeks after the last dose taken to check on your health and any potential side effects.
This study plans to enroll approximately 195 patients.
Description of treatment or intervention (mechanism of action):
- GB004 (the study drug) is administered as a tablet, and taken by mouth.
- GB004 is a gut-targeted HIF1-α stabilizer, HIF1-α is known to play an important role in restoring the gut barrier, and modulating local immune response.
- GB004 is not known to suppress the immune system.
Patient Participation Requirements:
- If you decide to participate in the SHIFT-UC Study you could be in the study for up to 70 weeks.
- During the first five weeks you will be asked to undergo a number of tests, and your medical history will be reviewed to determine whether the SHIFT-UC Study is right for you.
- If you are determined to be a good fit for the SHIFT-UC Study during the screening period, and choose to continue your participation in the study, you will be randomly assigned to receive the study drug (GB004), placebo, or a combination of the study drug and placebo (GB004 + placebo) for up to 36 weeks.
- After completing the placebo-controlled dosing period you will have the opportunity to continue on in the open-label period where you will be assigned to receive the study drug (GB004) for up to 24 weeks.
- Your participation in the study will end 4 weeks after your last dose.
- In total, you will be asked to visit the study site about 16 times over the 70-week duration of the study.
- Study visits will include health and well-being checks, such as medical questionnaires, physical examinations, blood, urine and stool samples, tests on your heart (ECGs), and two flexible sigmoidoscopies, an examination of the lower part of the colon, are planned after the screening visit and may also be performed if the study doctor decides to complete an additional visit.
- You will also be asked to complete a daily study diary, to record symptoms related to your UC.
Possible risks and side effects:
- There are risks associated with taking any medication and the same applies to the study drug.
- You may experience side effects or find that your ulcerative colitis symptoms do not change or increase in severity.
- It is important that you mention any concerns to your study doctor as they will be able to give you more detailed information.
Progress to date:
- A phase 1b study has been conducted in 23 patients with UC has been completed, and the results presented at UEGW 2020.
- More information about the Phase 1b study can be found at: https://clinicaltrials.gov/ct2/show/NCT03860896?term=GB004&draw=2&rank=1