Compares JNJ-78934804 with guselkumab in ulcerative colitis
Tests JNJ-78934804 against guselkumab in adults with moderately to severely active ulcerative colitis.
Key facts
- Who runs it
- Janssen Research & Development, LLC
- Where
- Plovdiv, Sofia, Sofiya, and Varna, BulgariaSee the 8 sitesAlso in 32 other countries, 319 sites
- Trial code
- Registry title
- A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 644 people, planned
- Started
- 23 May 2026
- Expected to end
- 16 Oct 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- JNJ-78934804
- Guselkumab
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderately to severely active ulcerative colitis who did not respond well to, or could not tolerate, earlier approved medicines.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Ulcerative colitis diagnosed at least 12 weeks before screening, with endoscopy and biopsy findings. The disease must be moderately to severely active: modified Mayo score of 5 to 9 and a Mayo endoscopy subscore of 2 or higher.
- Earlier treatment
- Must have had an inadequate first response, loss of response, or intolerance to earlier approved systemic therapies. Cannot have had an inadequate response, loss of response, allergy or intolerance to guselkumab or golimumab.
Main reasons for not taking part
- Inflammation only in the rectum (isolated proctitis)
- Other types of colitis, such as indeterminate, microscopic, ischemic or Crohn's colitis
- Past or ongoing long-lasting or recurring infectious disease
- Pregnant, breastfeeding, or planning to become pregnant
- Planning to father a child during the trial or within 6 months after the last dose
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC
- Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screening video endoscopy
- 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
Who cannot take part
- Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab
- Has a history of or ongoing chronic or recurrent infectious disease
- 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 the screening video endoscopy OR Has a diagnosis of isolated proctitis
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CD
- 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 months after the last dose of study intervention
Where in Bulgaria
Also in 32 other countries, 319 sites
- MBAL Sveta Karidad EADPlovdiv, BulgariaTaking people
- Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOODSofia, BulgariaTaking people
- Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EADSofia, BulgariaTaking people
- University Multiprofile Hospital For Active Treatment St. Ivan Rilski EADSofia, BulgariaTaking people
- Acibadem City Clinic Tokuda University Hospital EADSofiya, BulgariaTaking people
- Diagnostic And Consultative Center Neoclinic EADSofiya, BulgariaTaking people
- Diagnostics And Consultation Center Convex Ltd.Sofiya, BulgariaTaking people
- MBAL Sveta Marina EADVarna, BulgariaTaking people
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- JNJ-78934804Treatment being tested
Participants will receive JNJ-78934804 induction dose at Weeks 0, 4, and 8 followed by JNJ-78934804 maintenance dose, once every 4 weeks (q4w) starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase.
- GuselkumabExisting treatment, for comparison
Participants with moderately to severely active UC will receive guselkumab induction dose at Weeks 0, 4, and 8 followed by guselkumab maintenance dose q4w starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase.
Treatment: JNJ-78934804 and Guselkumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 78934804UCO3001: 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 Ulcerative Colitis
- Plain-language title
- Compares JNJ-78934804 with guselkumab in ulcerative colitisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 3 November 2026