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Efficacy & Safety of TD-1473 in Ulcerative Colitis

NCT03758443 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2022-11-15

Study results available
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Summary

A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.

Conditions

  • Ulcerative Colitis (UC)

Interventions

DRUG

TD-1473 Dose A

See Arm description

DRUG

TD-1473 Dose B

See Arm description

DRUG

TD-1473 Dose C

See Arm description

DRUG

Placebo

See Arm description

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
2019-03-11
Primary Completion
2021-10-20
Completion
2021-10-20
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • France
  • Georgia
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Poland
  • Portugal
  • Romania
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

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 NCT03758443 on ClinicalTrials.gov