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A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease

NCT04655807 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-04-27

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of JNJ-64304500 as add-on therapy to standard of care (SOC) biologic treatment with anti-tumor necrosis factor alpha or anti-interleukin 12/23 inhibitors in participants with active Crohn's disease in response but not remission to SOC biologic therapy.

Conditions

  • Crohn Disease

Interventions

DRUG

JNJ-64304500

JNJ-64304500 will be administered as SC injection.

DRUG

Placebo

Matching placebo will be administered as SC injection.

DRUG

Adalimumab

Adalimumab will be administered as SOC biological therapy.

DRUG

Ustekinumab

Ustekinumab will be administered as SOC biological therapy.

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
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-03
Primary Completion
2023-05-24
Completion
2023-09-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04655807 on ClinicalTrials.gov