Colitis, Ulcerative
JNJ-78934804 Compared With Guselkumab for Active Ulcerative Colitis
This Phase 3 study is comparing the effectiveness and safety of injected JNJ-78934804 with guselkumab in adults with moderately to severely active ulcerative colitis.
Registry title: A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
12 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years and older
- Treatment
- JNJ-78934804 or Guselkumab
- Design
- Randomized · Double
- Central study contact
- Study Contact844-434-4210Participate-In-This-Study1@its.jnj.com
- Sponsor
- Janssen Research & Development, LLC
Research question
At Week 48, how do the effectiveness and safety of JNJ-78934804 compare with guselkumab for moderately to severely active ulcerative colitis?
Participant snapshot
Who the study is looking for
- The study is looking for adults age 18 or older with ulcerative colitis.
- Ulcerative colitis must have been diagnosed at least 12 weeks before screening, with supporting endoscopy and pathology evidence.
- The study is looking for people whose ulcerative colitis is moderately to severely active according to specified Mayo and endoscopy scores.
- Participants must have had an inadequate response, loss of response, or intolerance to previous approved systemic treatment.
Participation overview
What participation may involve
Participants receive scheduled injections of JNJ-78934804 or guselkumab during a double-blind treatment phase through Week 48. Participants meeting rescue criteria receive JNJ-78934804, and some completers may be offered a long-term extension. What participation may involve: - JNJ-78934804 or guselkumab induction doses are given at Weeks 0, 4, and 8, followed by maintenance doses every four weeks starting at Week 12. - Participants who meet unspecified rescue criteria receive JNJ-78934804 at Weeks 16, 20, and 24, followed by dosing every four weeks starting at Week 28. - The study evaluates symptoms, endoscopic findings, tissue inflammation, quality of life, fatigue, mental health, and adverse events at reported time points. - After Week 48, participants considered by the investigator to benefit from continued study intervention may have an opportunity to enter the long-term extension phase. The double-blind treatment phase continues through Week 48. The registry also describes an optional long-term extension and safety follow-up lasting up to approximately three years, but does not state each participant's total duration.
Study interventions
What participants may receive or do
- JNJ-78934804: JNJ-78934804 is given by an injection under the skin. It is used as the experimental treatment and may also be given as rescue treatment when the study's rescue criteria are met.
- Guselkumab: Guselkumab, also listed as TREMFYA, is given by an injection under the skin and serves as the active comparison treatment.
Study design
How the comparison works
This is a Phase 3, parallel-group treatment study comparing JNJ-78934804 with the active comparator guselkumab in an estimated 644 participants. Participants are randomly assigned to one of the two parallel treatment groups. The study is double-blind: both participants and investigators are masked to treatment assignment during the double-blind phase. Guselkumab is the active control used to compare outcomes with JNJ-78934804.
Reported activities
Procedures and tests
- Screening includes confirmation of the ulcerative colitis diagnosis using endoscopic evidence and a histopathology report.
- A screening video endoscopy is centrally reviewed to determine the modified Mayo score and endoscopy subscore.
- Endoscopic improvement is assessed using an endoscopy subscore at Weeks 12 and 48.
- Colon tissue is assessed for histologic remission, including signs of neutrophils, crypt destruction, erosion, ulceration, and granulation tissue.
- Stool frequency and rectal bleeding are assessed as components of clinical remission and symptom response.
- Participants complete the seven-item Patient-Reported Outcomes Measurement Information System fatigue questionnaire.
- Participants complete the 32-item Inflammatory Bowel Disease Questionnaire about symptoms, daily functioning, social life, and emotional well-being.
- Participants complete the 29-item Patient-Reported Outcomes Measurement Information System assessment covering mental and physical health domains.
- The study records adverse events and serious adverse events for up to approximately three years.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Ulcerative colitis must have been diagnosed at least 12 weeks before screening and supported by both endoscopy and a pathology report.
- At Week 0, the centrally reviewed modified Mayo score must be from 5 through 9.
- Central review of the screening video endoscopy must produce an endoscopy subscore of at least 2.
- A previous approved systemic treatment must have produced an inadequate initial response, a later loss of response, or intolerance.
- Participants must be age 18 or older.
Possible reasons someone may not be able to join
- People with ulcerative colitis limited to the rectum or extending less than 20 centimeters from the anal verge are excluded.
- People with indeterminate, microscopic, ischemic, or Crohn's colitis, or findings suggesting Crohn's disease, are excluded.
- A history of, or an ongoing, chronic or recurring infectious disease is exclusionary.
- Previous inadequate response, loss of response, allergy, hypersensitivity, or intolerance to guselkumab or golimumab is exclusionary.
- People who are pregnant, breastfeeding, planning pregnancy, or planning to father a child during the study or within six months after the final dose are excluded.
Important unknowns
What the record does not make clear
- The registry reports dosing and assessment weeks but does not provide the complete number, length, or format of study visits.
- The double-blind phase reaches Week 48 and an extension may be offered, but the total duration for an individual participant is not stated.
- The registry does not state which existing ulcerative colitis medicines may continue during the study.
- No washout periods or timing rules for previous treatments are provided.
- The record gives a JNJ-78934804 rescue schedule but does not define the rescue criteria or describe other permitted rescue options.
- A screening video endoscopy and endoscopy-based outcomes are described, but the number and timing of all required endoscopies are not fully reported.
- The registry does not explain which study-related or routine-care costs are covered or billed to insurance.
- The registry does not state whether participants receive compensation.
- The registry does not state whether travel, lodging, parking, or meal support is available.
- An extension may be offered to some Week 48 completers, but access to study treatment after the extension or study ends is not described.
- The registry lists recruiting locations, but current availability and screening capacity at any particular site must be confirmed.
Before contacting the site
Questions for the study team
- What is the complete schedule for screening, injections, assessments, and follow-up visits?
- How many endoscopies and biopsies are required, and at which study visits?
- What are the rescue criteria, and what treatment choices are available if symptoms worsen?
- Which current medicines may continue, and are any washout or stable-dose periods required?
- What costs, insurance charges, compensation, and travel support should participants expect?
- How does entry into the long-term extension work, and what treatment access is available when the study ends?
Before changing care
Questions for your gastroenterologist
- How might the study's treatment plan affect the ulcerative colitis medicines I currently take?
- How stable is my ulcerative colitis now, and what would worsening disease mean for my usual care?
- What approved treatment alternatives should I understand while considering whether to contact the study team?
- How should you and the research team coordinate endoscopies, pathology results, medicines, and care if my symptoms change?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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).
Study design and administration
- Organization
- Janssen Research & Development, LLC
- Organization class
- Industry
- Organization study ID
- 78934804UCO3001
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Double
- Who is masked
- Participant, Investigator
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
JNJ-78934804
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 (DB) treatment phase (Week 48) and benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase.
Interventions: Drug: JNJ-78934804
Active Comparator
Guselkumab
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 DB treatment phase (Week 48) and benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the LTE phase.
Interventions: Drug: JNJ-78934804, Drug: Guselkumab
Interventions
Drug
JNJ-78934804
JNJ-78934804 will be administered subcutaneously.
Drug
Guselkumab
Guselkumab will be administered subcutaneously.
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (4)
- 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.Registry-derived · unreviewed
- 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 endoscopyRegistry-derived · unreviewed
- An endoscopy subscore \>=2 as obtained during central review of the screening video endoscopyRegistry-derived · unreviewed
- Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapiesRegistry-derived · unreviewed
Exclusion criteria (5)
- 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 proctitisRegistry-derived · unreviewed
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CDRegistry-derived · unreviewed
- Has a history of or ongoing chronic or recurrent infectious diseaseRegistry-derived · unreviewed
- Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumabRegistry-derived · unreviewed
- 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 interventionRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Percentage of Participants in Clinical Remission at Week 48
Time frame: At Week 48
Clinical remission is defined as an stool frequency (SF) subscore of 0 or 1, rectal bleeding (RB) subscore of 0, and an endoscopy subscore of 0 or 1.
Secondary outcome
Percentage of Participants with Endoscopic Improvement at Week 48
Time frame: At Week 48
Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Secondary outcome
Percentage of Participants with Corticosteroid-free (90 day) Clinical Remission at Week 48
Time frame: At Week 48
Corticosteroid-free (90 day) clinical remission is defined as clinical remission at the visit and not receiving corticosteroids for 90 days prior to the visit.
Secondary outcome
Percentage of Participants Achieving a Combination of Histologic Remission and Endoscopic Improvement at Week 48
Time frame: At Week 48
Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. Histologic remission is defined as an absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system.
Secondary outcome
Percentage of Participants with Fatigue Response (PROMIS Fatigue Short Form 7a) at Week 48
Time frame: At Week 48
Fatigue response is defined as a greater than or equal to (\>=) 7- point reduction in the patient-reported outcomes measurement information system (PROMIS) fatigue short form 7a total score from baseline. The PROMIS fatigue SF-7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise).
Secondary outcome
Percentage of Participants with Sustained Mayo SF Less Than or Equal to (<=) 1 and RB=0
Time frame: At Weeks 12, 24, and 48
Percentage of participants with a SF subscore of 0 or 1 and RB subscore of 0 at three assessment time points of Week 12, Week 24, and Week 48 will be reported.
Secondary outcome
Percentage of Participants in Abdominal Pain Remission at Week 48
Time frame: At Week 48
Percentage of participants in abdominal pain remission at week 48 will be reported.
Secondary outcome
Percentage of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Response at Week 48
Time frame: At Week 48
IBDQ response is defined as improvement from baseline in the total IBDQ score of \>= 16 points. The IBDQ is a 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate the disease-specific health-related quality of life (HRQoL) across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability).
Secondary outcome
Percentage of Participants with PROMIS-29 Mental Component Summary (MCS) Response at Week 48
Time frame: At Week 48
PROMIS 29 MCS response is defined as a \>= 7-point improvement from baseline in PROMIS 29 MCS response at Week 48. The PROMIS-29 is a collection of short forms containing 4 items for each of 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities). The PROMIS-29 MCS will be assessed, which is primarily informed by domains of emotional distress (depression/anxiety) and fatigue as well as sleep disturbance where higher MCS scores reflect better mental health.
Secondary outcome
Percentage of Participants in Clinical Remission at Week 12
Time frame: At Week 12
Clinical remission is defined as an SF subscore of 0 or 1, RB subscore of 0, and an endoscopy subscore of 0 or 1.
Secondary outcome
Percentage of Participants with Endoscopic Improvement at Week 12
Time frame: At Week 12
Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Secondary outcome
Percentage of Participants with Mayo SF/RB Response at Week 2
Time frame: At Week 2
Mayo SF/RB response is defined as a decrease from baseline in the sum of the SF and the RB subscores by \>=30 percent (%) and \>= 1 point, with either a \>= 1 point decrease from baseline in the RB subscore or an RB subscore of 0 or 1.
Secondary outcome
Percentage of Participants with Adverse Events (AE) and Serious AEs (SAEs)
Time frame: Up to approximately 3 years
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important.
Recruiting locations in the United States
Clinnova Research
RecruitingAnaheim, California, 92805, United States
Gastro SB Clinic
RecruitingChula Vista, California, 91910, United States
Medical Associates Research Group, Inc.
RecruitingSan Diego, California, 92123, United States
Peak Gastroenterology Associates
RecruitingColorado Springs, Colorado, 80907, United States
Sanchez Clinical Research, Inc
RecruitingMiami, Florida, 33157-6575, United States
GCP Clinical Research
RecruitingTampa, Florida, 33609, United States
Tri-State Gastroenterology Assoc
RecruitingCrestview Hills, Kentucky, 41017, United States
Michigan Center of Medical Research
RecruitingFarmington Hills, Michigan, 48334, United States
New York Gastroenterology Associates
RecruitingNew York, New York, 10075, United States
Great Lakes Gastroenterology Research, LLC
RecruitingMentor, Ohio, 44060, United States
Digestive Disease Specialists Inc
RecruitingOklahoma City, Oklahoma, 73114, United States
Southern Star Research Institute, LLC
RecruitingSan Antonio, Texas, 78229, United States
This study also lists 51 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- May 11, 2026
- Primary completion
- Aug 11, 2028
- Overall completion
- Oct 30, 2030
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.