Efficacy and Safety of TD-1473 in Crohn's Disease

A Phase 2 multi-center, randomized, double blind, placebo-controlled, parallel-group study to
evaluate the efficacy and safety of 12 weeks of induction therapy with TD˗1473 in subjects
with moderately-to-severely active CD. This study includes 3 phases: Screening, Induction,
and Active Treatment Extension (ATE). The Induction phase of the study is a randomized,
double blind, placebo controlled, parallel group study evaluating 2 oral dose levels of
TD-1473 compared to placebo for 12 weeks in subjects with moderately to-severely active CD.
Subjects who complete Induction will continue to receive TD-1473 in the ATE, for up to 24
additional weeks.

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 ≥ 6 (≥ 4 if isolated ileal disease) with ulceration (corresponding to
a score of 1) in at least 1 of the 5 ileocolonic segments on the Presence of Ulcers
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

- Any prior exposure to an approved JAK inhibitor or potential exposure to an
investigational JAK inhibitor

- 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