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

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.

Timeline

Start

2019-09-23

Primary completion

2021-11-17

Completion

2021-12-22

Outcome

Missed primary endpoint

Stopped: “IAC completed review of futility analysis data \& determined that futility criteria were met. As a result, Janssen made decision to stop trial immediately.”

registry analysis (other test); Placebo vs JNJ-67864238; p = 0.288; Least Squares Means 37.4 (90% CI -21.0 to 95.8); Mixed Model for Repeated Measures (MMRM) NCT04102111 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	JNJ-67864238	Unknown	—	Oral

Indications