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

NCT03635112 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2023-03-13

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Placebo

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

DRUG

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.

Sponsors & Collaborators

  • Theravance Biopharma

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Theravance Biopharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2021-12-30
Completion
2021-12-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Bulgaria
  • Croatia
  • France
  • Georgia
  • Germany
  • Greece
  • Hungary
  • Israel
  • New Zealand
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03635112 on ClinicalTrials.gov