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A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis

NCT01959282 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2019-01-04

No results posted yet for this study

Summary

The purpose of the study is to evaluate dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

Placebo

Participants will receive placebo once daily

DRUG

JNJ-54781532 25 mg once daily

Participants will receive 25 mg of JNJ-54781532 once daily

DRUG

JNJ-54781532 75 mg once daily

Participants will receive 75 mg of JNJ-54781532 once daily

DRUG

JNJ-54781532 150 mg once daily

Participants will receive 150 mg of JNJ-54781532 once daily

DRUG

JNJ-54781532 75 mg twice daily

Participants will receive 75 mg of JNJ-54781532 twice daily

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-15
Primary Completion
2015-05-20
Completion
2015-12-05
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • France
  • Germany
  • Hungary
  • Israel
  • Netherlands
  • Poland
  • Romania
  • Russia
  • 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 NCT01959282 on ClinicalTrials.gov