MedTrace Logo

Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease

NCT02877134 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2025-04-29

Study results available
· View outcomes & findings →

Summary

The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.

Conditions

  • Crohn Disease

Interventions

DRUG

JNJ-64304500

Participants will receive JNJ-64304500 Subcutaneously.

DRUG

Placebo

Participants will receive placebo Subcutaneously.

DRUG

Ustekinumab

Participants will receive ustekinumab as per the dosing regimen.

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
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-25
Primary Completion
2020-12-10
Completion
2022-01-24
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Canada
  • France
  • Germany
  • Hungary
  • Japan
  • Poland
  • Romania
  • Russia
  • South Korea
  • Ukraine
  • United Kingdom

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 NCT02877134 on ClinicalTrials.gov