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New treatment option for Colitis, Ulcerative
Official title A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT07577856
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 colitis, ulcerative.
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 ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).
- 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
- Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report...
- Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained...
- An endoscopy subscore \>=2 as obtained during central review of the screening video endoscopy
- Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies
You likely can't join if
- Isolated proctitis (UC limited to the rectum only or to less than [\<] 20 centimeter [cm] from the anal verge) as determined during central review of...
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CD
- Has a history of or ongoing chronic or recurrent infectious disease
- Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab
- Is a participant who is pregnant, breastfeeding, or planning to become pregnant, or plans to father a child, while enrolled in this study or within 6...
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
- San Antonio, Texas, United States
- Kurralta Park, Australia
- Vancouver, British Columbia, Canada
- London, Ontario, Canada
- Haifa, Israel
- Kfar Saba, Israel
- Ramat Gan, Israel
- Tel Aviv, Israel
- Hamamatsu, Japan
- Higashi-Ibaraki, Japan
- Kagoshima, Japan
- Ōita, Japan
- Saga, Japan
- Sapporo, Japan
+ 5 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 19 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.