A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo˗Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Patients with Moderately-to-Severely Active Crohn’s Disease
To assess the change in symptoms and overall safety of TD-1473, which is an investigational product, in moderately-to-severely active Crohn's disease.
Key Inclusion Criteria:
- Patients must be at least 18 years of age at screening, diagnosed with Crohn's disease for at least 3 months prior to screening, and experiencing moderately-to-severely active Crohn's Disease 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) therapy.
- Patients who are likely to require surgery for Crohn's disease or other major surgeries.
- Patients who have a current bacterial, parasitic, fungal, or viral infection.
- There are 2 treatment phases in the DIONE study. In the first treatment phase (12 weeks), if you qualify and join 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). Neither you nor your doctor will know which medication you are receiving. This is a common technique in clinical studies, as it helps researchers understand the effects of the investigational medication.
- After this 12-week period, if you remain in the study, you will start the second treatment phase (48 weeks) where you will receive TD-1473, and your study doctor will continue to monitor your progress.
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 Crohn's disease.
Patient Participation Requirements
- If you qualify, join and remain in the study, your participation will last about 17 months and require 14 scheduled visits to your local study center.
- At every visit, you will be asked about your Crohn's disease 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 2 standard, diagnostic colonoscopies.
- The first is done at the beginning of the study, and the second is done 3 months later to measure the effect of the study medication on your Crohn's disease.
- 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.