Crohn Disease study: JNJ-78934804 vs Guselkumab
Official title A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov ID: NCT07577843
What this study is testing
What is JNJ-78934804?
This is an investigational injectable medicine being studied as a potential treatment for moderately to severely active Crohn's disease.
Also referred to as JNJ-4804.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out how well the new drug JNJ-78934804 works and how safe it is compared to guselkumab.
- Who it's for
- The study is looking for people with moderately to severely active Crohn's disease.
- What's involved
- Participants will receive either the new drug or guselkumab and undergo tests to check how their body responds.
- Time commitment
- The study lasts 48 weeks and requires regular visits to the clinic.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (\>=) 12 weeks before screening including both...
- 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...
- Have moderately to severely active ileal and/or colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple...
- Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies
You likely can't join if
- 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...
- 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...
- Currently has or is suspected of having an abscess
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Sun City, Arizona, United States
- Anaheim, California, United States
- Chula Vista, California, United States
- Los Alamitos, California, United States
- San Diego, California, United States
- Colorado Springs, Colorado, United States
- Lakewood Rch, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Suwanee, Georgia, United States
- Crestview Hills, Kentucky, United States
- Lafayette, Louisiana, United States
- Metairie, Louisiana, United States
- Lee's Summit, Missouri, United States
- New York, New York, United States
- Rochester, New York, United States
- Chapel Hill, North Carolina, United States
- Mentor, Ohio, United States
+ 226 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; Sun City, Arizona, United States; Anaheim, California, United States; Chula Vista, California, United States; Los Alamitos, California, United States; San Diego, California, United States and 240 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.