Efficacy and Safety of TD-1473 in Crohn's Disease (DIONE)
Crohn's Disease
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring TD-1473, Janus kinase inhibitor, JAK inhibitor, Inflammatory Bowel Disease, IBD, Crohn's Disease, Intestinal restriction
Eligibility Criteria
Inclusion Criteria:
- Is at least 18 years of age at screening
- Males and females with clinical evidence of Crohn's disease for at least 3 months duration at screening
- Moderately-to-severely active Crohn's Disease at baseline, as defined by a Crohn's Disease Activity Index (CDAI) score of 220-450 inclusive
- SES-CD score of ≥ 3 with ulceration (corresponding to a score of 1) in at least 1 of the 5 ileocolonic segments on the Ulcerated Surface subscore of the SES-CD]
- Is corticosteroid-dependent or has demonstrated 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).
- Additional inclusion criteria apply
Exclusion Criteria:
- Is currently receiving biologic (anti-TNF, anti-integrin, or anti-IL12/23) therapy
- Has a current bacterial, parasitic, fungal, or viral infection
- Has clinically significant abnormalities in laboratory evaluations
- Prior exposure or potential exposure to a JAK inhibitor that was stopped due to intolerance or lack of efficacy
- Subject has participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening or 5x the half-life of the investigational drug, whichever is longer, or is currently participating in another trial of an investigational drug (or medical device)
- Subject has failed ≥ 3 biologic agents of 3 different mechanisms of action (i.e., anti-TNF, anti-integrin, and anti-IL12/23)
- Additional exclusion criteria apply
Sites / Locations
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- PMG Research of Salisbury
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Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
Active Treatment TD-1473 with Dose A
Active Treatment TD-1473 with Dose B
Placebo
1 oral Dose A daily of TD-1473 for 12 weeks in subjects with moderately to-severely active CD. Subjects who complete Induction will continue to receive TD-1473 at Dose A in the Active Treatment Arm for up to 48 additional weeks.
1 oral Dose B daily of TD-1473 for 12 weeks in subjects with moderately to-severely active CD. Subjects who complete Induction will continue to receive TD-1473 at Dose B in the Active Treatment Arm for up to 48 additional weeks.
1 oral dose daily of placebo for 12 weeks in subjects with moderately to-severely active CD. Subjects who complete Induction will receive TD-1473 at Dose A in the Active Treatment Arm for up to 48 additional weeks.