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

Theravance Biopharma

Status and phase: Terminated; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: TD-1473; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03635112

0173

2018-001272-37 (EudraCT Number)

Details and patient eligibility

About

A Phase 2 study to evaluate the efficacy, safety and tolerability of TD-1473 in subjects with moderately-to-severely active Crohn's Disease with up to 48 weeks of treatment.

Full description

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 Crohn's Disease. 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 48 additional weeks.

Enrollment: 167 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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167 participants in 3 patient groups, including a placebo group

Active Treatment TD-1473 with Dose A

Active Comparator group

Description:

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.

Treatment:

Drug: TD-1473

Active Treatment TD-1473 with Dose B

Active Comparator group

Description:

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.

Treatment:

Drug: TD-1473

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: TD-1473