RightFit
RecruitingPhase 3

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

A Phase 3, Randomized, Double-blind, and Active-controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well JNJ-78934804 works and how safe it is compared with guselkumab after 48 weeks. It is for people with moderate to severe active Crohn’s disease, a long-term disease of the intestines.

The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active Crohn's disease (a long-term, progressive \[worsens with time\] and life-threatening disease of the intestine).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have had a Crohn’s disease diagnosis for at least 12 weeks before screening, confirmed by a scope exam and a tissue sample report. Crohn’s with fistulas (abnormal tunnels between body parts) is allowed.
  • Have moderate to severe active Crohn’s, with a disease activity score of 220–450. Also have an average of at least 4 liquid or very soft stools a day, or an average belly pain score of at least 2.
  • Have moderate to severe active Crohn’s in the last part of the small intestine, the colon, or both, confirmed by study reviewers using a video scope exam.
  • Have tried approved medicines that act throughout the body, but they did not work well enough, stopped working, or caused side effects you could not tolerate.

Who can't join

  • Have another type of colon inflammation: indeterminate, microscopic, ischemic, or ulcerative colitis. Signs that strongly suggest ulcerative colitis also rule you out.
  • Have Crohn’s complications, such as bowel narrowing that causes symptoms, or another problem that may need bowel surgery during the study.
  • Have a working stoma or ostomy—an opening made by surgery that lets bowel waste leave the body.
  • Have a history of short bowel syndrome (too little bowel to absorb nutrients well), are missing more than 2 of the 5 bowel sections used for study scoring, or have another condition that could prevent a clear measure of treatment response.
  • Have, or may have, an abscess—a pocket of pus from an infection.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion criteria: * Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (\>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD * Have moderately to severely active CD based on crohn's disease activity index (CDAI) criteria defined as a baseline CDAI score \>= 220 but less than or equal to (\<=) 450 and either: a. Mean daily stool frequency (SF) count \>= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score \>= 2.0, based on the unweighted CDAI component of abdominal pain (AP) * Have moderately to severely active ileal and/or colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteria * Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies Exclusion criteria: * Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC * Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study * Presence of draining (that is, functioning) stoma or ostomy * Has a history of short bowel syndrome, is missing greater than (\>) 2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to use efficacy assessment tools (such as CDAI) to assess response to study intervention * Currently has or is suspected of having an abscess

Study sites (22)

CA

CO

FL

GA

KY

LA

MI

MO

NC

NY

OH

OK

OR

TN

TX

WA