A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD˗1473 in Patients with Moderately-to-Severely Active UC
To assess the change in symptoms and overall safety of TD-1473, which is an investigational product, in moderately-to-severely active UC.
Key Inclusion Criteria:
- Patients must be at least 18 years of age at screening, diagnosed with ulcerative colitis for at least 3 months prior to screening, experiencing moderately-to-severely active ulcerative colitis at baseline.
- Patients who have either needed steroids to control their symptoms or have had inadequate response or intolerance to conventional therapy (aminosalicylates, corticosteroids and immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate) or biologics (e.g., anti-TNF therapy, anti-IL-12/23 (anti-interleukin), anti-integrin).
Key Exclusion Criteria:
- Patients currently receiving biologic (anti-TNF, anti-integrin, or anti-IL12/23) treatment.
- Patients who are likely to require surgery for UC or other major surgeries.
- Patients who have a current bacterial, parasitic, fungal, or viral infection.
Study Phase: 2b/3
- There are 2 treatment phases in the RHEA study. If you qualify for and join the study, in the first treatment phase (8 weeks), you will have a 75% chance of receiving TD-1473, and a 25% chance of receiving a "placebo" (an identical-looking pill, but with no active medication).
- After 8 weeks, if you remain in the study and are not experiencing a clinical response, and were receiving TD-1473, you will continue taking TD-1473 for 8 more weeks. If instead you were receiving the placebo, you will now switch over and receive TD-1473 for 8 weeks.
- After this 8 - 16 week period, if you remain in the study and are experiencing a clinical response, you will continue to the next treatment phase, involving 44 weeks of treatment. If you experienced a clinical response after either 8 weeks of placebo, or 16 weeks of TD-1473, you will continue to receive that same medication at the same dose. Otherwise, you will be randomly re-assigned to receive TD-1473 (75% chance) or placebo (25% chance).
Description of treatment or intervention (mechanism of action)
- TD-1473 is a once daily, gut-selective inhibitor of all types of janus kinase (JAK). JAK is an enzyme that plays a role in inflammation seen in patients with ulcerative colitis.
Patient Participation Requirements
- If you qualify, join and remain in the study, your participation may last up to 16 months and involve approximately 15 scheduled visits to your local study center. However, you may have up to 23 visits if you have recurrent symptoms during the study. In total, you will receive treatment for up to 15 months.
- At every visit, you will be asked about your UC symptoms and how you are feeling, and will provide a blood sample. For most visits, you will also receive a routine physical exam. As part of the study, you will receive up to 4 standard, diagnostic colonoscopies or sigmoidoscopies (where only the last portion of the colon is examined). These are done at the beginning of the study to measure the severity of your UC, and then 3 more times over the course of the next 13 - 15 months to measure the effect of the study medication on your UC. Before you decide to participate, your study team will provide you with a detailed summary of what will happen at each visit, so that you can make an informed decision about joining the study.
Possible risks and side effects
- There are risks associated with taking any medication and the same applies to the study drug. Not all side effects are known, because we are still learning more about the study drug.
- You may experience side effects or find that your Crohn's disease symptoms do not change, or may 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