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New treatment option for Crohn Disease
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?
JNJ-78934804 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for crohn 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
- 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).
- 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's taking place
- Anaheim, California, United States
- Chula Vista, California, United States
- Colorado Springs, Colorado, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- New York, New York, United States
- Kurralta Park, Australia
- Vancouver, British Columbia, Canada
- London, Ontario, Canada
- Haifa, Israel
- Kfar Saba, Israel
- Ramat Gan, Israel
- Tel Aviv, Israel
- Hirosaki, Japan
- Kagoshima, Japan
- Kumamoto, Japan
- Osaka, Japan
- Sapporo, Japan
- Istanbul, Turkey (Türkiye)
- Kocaeli, Turkey (Türkiye)
+ 1 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 - 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?
Study sites include Anaheim, California, United States; Chula Vista, California, United States; Colorado Springs, Colorado, United States; Miami, Florida, United States; Tampa, Florida, United States; New York, New York, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.