NCT04102111

A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants With Moderately to Severely Active Crohn's Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of JNJ-active as measured by the change in the Crohn's Disease Activity Index (CDAI) score and Simplified Endoscopic Score for Crohn's disease (SES-CD) from baseline at Week 12.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	JNJ-67864238	Participants will receive oral tablets of JNJ-67864238 twice daily.
DRUG	Placebo	Participants will receive oral tablets of matching placebo twice daily.

Timeline

• Start date: 2019-09-23
• Primary completion: 2021-11-17
• Completion: 2021-12-22
• First posted: 2019-09-25
• Last updated: 2025-02-04
• Results posted: 2022-12-09

Locations

63 sites across 7 countries: United States, Argentina, Germany, Italy, Poland, Russia, Ukraine

Regulatory

• FDA-regulated drug study