Clinical trial

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 Subjects With Moderately-to-Severely Active Crohn's Disease

Name

0173

Description

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.

Trial arms

Trial start

2018-11-19

Estimated PCD

2021-12-30

Trial end

2021-12-30

Status

Terminated

Phase

Early phase I

Treatment

Placebo

Placebo will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating.

Arms:

Placebo

TD-1473

TD-1473, at Dose A or Dose B depending upon arm, will be taken daily by mouth (orally) for up to 12 weeks in the morning before eating. An additional 48 weeks either at Dose A or Dose B, depending on arm, may be administered if subjects finish the 12 week induction period.

Arms:

Active Treatment TD-1473 with Dose A, Active Treatment TD-1473 with Dose B, Placebo

Size

167

Primary endpoint

Change From Baseline in Crohn's Disease Activity Index (CDAI) Score

Baseline to Week 12

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 167, 'type': 'ACTUAL'}}

Updated at

2023-03-13

1 organization

2 products

1 indication

Organization

Product

Indication

Product