Crohn Disease
Phase 3 Study of JNJ-78934804 for Moderately to Severely Active Crohn’s Disease
This randomized Phase 3 study is comparing JNJ-78934804 with guselkumab at Week 48 in adults with moderately to severely active Crohn’s disease that did not respond adequately to, stopped responding to, or was not tolerated with previously approved systemic therapies.
Registry title: A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
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 JNJ-78934804 and guselkumab compare in clinical and endoscopic remission and in reported safety outcomes among participants with moderately to severely active Crohn’s disease?
Participant snapshot
Who the study is looking for
- The study is looking for adults age 18 or older.
- The study is looking for people whose Crohn’s disease or fistulizing Crohn’s disease was diagnosed at least 12 weeks before screening and documented by endoscopy and histopathology.
- The study is looking for people with moderately to severely active ileal and/or colonic Crohn’s disease confirmed by symptoms and central review of a screening video ileocolonoscopy.
- The study is looking for people who had an inadequate initial response, lost response, or could not tolerate previously approved systemic therapies.
- Recruiting locations are listed in the United States, Australia, Brazil, Canada, Israel, Japan, Malaysia, Taiwan, and Turkey.
Participation overview
What participation may involve
Participants receive scheduled injections of either JNJ-78934804 or guselkumab during a double-blind treatment phase through Week 48. Those meeting rescue criteria receive JNJ-78934804, and some completing Week 48 may be offered an optional long-term extension if the investigator believes continued study intervention may benefit them. What participation may involve: - Receive induction injections under the skin at Weeks 0, 4, and 8, followed by maintenance injections every four weeks beginning at Week 12. - Undergo a screening video ileocolonoscopy that is centrally reviewed to confirm the required level of ileal and/or colonic disease activity. - Complete Crohn’s disease symptom assessments, including stool frequency and abdominal-pain reporting used in the Crohn’s Disease Activity Index and patient-reported outcomes. - Have clinical, endoscopic, histologic, quality-of-life, mental-health, and adverse-event outcomes assessed as described in the registry. The double-blind treatment phase continues through Week 48. The registry also describes an optional long-term extension and adverse-event assessment for up to approximately three years, but it does not state each participant’s total participation duration.
Study interventions
What participants may receive or do
- JNJ-78934804: JNJ-78934804 is given by injection under the skin. Its assigned group receives induction doses at Weeks 0, 4, and 8, followed by maintenance dosing every four weeks starting at Week 12. Participants in either group who meet unspecified rescue criteria receive JNJ-78934804 on the rescue schedule.
- Guselkumab: Guselkumab, also listed as TREMFYA, is the active comparison drug and is given by injection under the skin. Its group receives induction doses at Weeks 0, 4, and 8, followed by maintenance dosing every four weeks starting at Week 12.
Study design
How the comparison works
This is a Phase 3, randomized, parallel-group treatment study comparing JNJ-78934804 with the active comparator guselkumab. Participants and investigators are masked during the double-blind treatment phase through Week 48. Participants are assigned at random to parallel groups, but the registry does not report the allocation ratio. The study is double-blind: both participants and investigators are masked to assigned treatment. Guselkumab is the active control used for comparison with JNJ-78934804.
Reported activities
Procedures and tests
- Subcutaneous injections of the assigned study drug on the reported induction and maintenance schedules.
- Screening video ileocolonoscopy with central review and scoring using the Simple Endoscopic Score for Crohn’s Disease.
- Crohn’s Disease Activity Index assessments, including stool-frequency and abdominal-pain measures.
- Intestinal tissue assessment for histologic remission using the Robarts Histopathology Index.
- Inflammatory Bowel Disease Questionnaire, a 32-item self-reported quality-of-life assessment.
- Patient-Reported Outcomes Measurement Information System 29 assessment covering mental health, physical function, pain, fatigue, sleep, and social participation.
- Monitoring and recording of adverse events and serious adverse events.
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
- Crohn’s disease or fistulizing Crohn’s disease must have been diagnosed at least 12 weeks before screening, with both endoscopic evidence and a histopathology report supporting the diagnosis.
- The baseline Crohn’s Disease Activity Index must be from 220 through 450, together with either mean daily stool frequency of at least 4.0 or mean daily abdominal-pain score of at least 2.0.
- Central review of the screening video ileocolonoscopy must show moderately to severely active Crohn’s disease in the ileum, colon, or both, based on Simple Endoscopic Score for Crohn’s Disease criteria.
- A previously approved systemic therapy must have produced an inadequate initial response, lost its response, or been intolerable.
Possible reasons someone may not be able to join
- People with indeterminate, microscopic, ischemic, or ulcerative colitis, or findings strongly suggesting ulcerative colitis, are excluded.
- People with symptomatic bowel strictures or stenoses, or another Crohn’s disease complication that may require intestinal surgery during the study, are excluded.
- A draining, functioning stoma or ostomy is an exclusion.
- People are excluded if they have short bowel syndrome, are missing more than two of five ileocolonic segments, or have another condition that could prevent or confuse assessment with tools such as the Crohn’s Disease Activity Index.
- A current or suspected abscess is an exclusion.
Important unknowns
What the record does not make clear
- The registry gives dosing and outcome time points but does not provide a complete visit schedule or distinguish clinic visits from other contacts.
- The record describes a double-blind phase through Week 48, an optional long-term extension, and adverse-event assessment for up to approximately three years, but not each participant’s total duration.
- The record does not state which current Crohn’s disease medicines may continue during the study.
- No required medication washout periods are reported.
- The registry states that participants meeting rescue criteria receive JNJ-78934804 at Weeks 16, 20, and 24 and then every four weeks from Week 28, but it does not define the rescue criteria or other rescue options.
- A screening video ileocolonoscopy and Week 48 endoscopic outcomes are described, but the complete schedule, biopsy requirements, preparation, sedation, and whether additional endoscopies are required are not reported.
- The record does not explain which study-related or routine-care costs are covered or billed to insurance.
- The record does not report whether participants receive compensation.
- The record does not report reimbursement or support for travel, lodging, meals, parking, or caregiving.
- The record does not say whether any visits or assessments may be completed remotely.
- An optional long-term extension may be available after Week 48, but its length, treatment rules, and access after the extension are not reported.
- The overall study and listed sites are marked recruiting, but the record does not confirm whether a particular site has an open slot for a specific participant.
Before contacting the site
Questions for the study team
- What is the full visit schedule, including screening, injections, assessments, and follow-up, and which visits must be in person?
- What is the chance of assignment to JNJ-78934804 versus guselkumab, and how is the masking maintained when the treatments are given?
- What are the rescue criteria, and what treatment choices are available if Crohn’s disease worsens before Week 48?
- How many ileocolonoscopies and biopsies are required, and what preparation, sedation, recovery time, and risks should I expect?
- Which current Crohn’s disease medicines may continue, which must stop, and are there washout periods?
- Which costs are covered, could insurance be billed, and are compensation or travel support available?
- If I complete Week 48, how is access to the long-term extension decided, how long does it last, and what treatment is provided?
- Is the site I am considering currently screening, and does it have an available opening?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn’s disease now, and what would worsening look like while I am being screened or treated in this study?
- How could stopping, continuing, or changing my current Crohn’s disease medicines affect my disease control and other treatment options?
- How do the study interventions and procedures compare with approved alternatives that are appropriate for my treatment history?
- Do my disease location, prior surgeries, strictures, ostomy status, or abscess history raise concerns that I should discuss with the research team?
- How should you and the research team coordinate symptom monitoring, urgent care, rescue treatment, and access to my medical records?
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 Crohn's disease (a long-term, progressive \[worsens with time\] and life-threatening disease of the intestine).
Study design and administration
- Organization
- Janssen Research & Development, LLC
- Organization class
- Industry
- Organization study ID
- 78934804CRD3001
- 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 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.
Interventions: Drug: JNJ-78934804
Active Comparator
Guselkumab
Participants 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 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)
- Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (\>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CDRegistry-derived · unreviewed
- 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 or equal to (\<=) 450 and either: a. Mean daily stool frequency (SF) count \>= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score \>= 2.0, based on the unweighted CDAI component of abdominal pain (AP)Registry-derived · unreviewed
- Have moderately to severely active ileal and/or colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteriaRegistry-derived · unreviewed
- Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapiesRegistry-derived · unreviewed
Exclusion criteria (5)
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UCRegistry-derived · unreviewed
- Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the studyRegistry-derived · unreviewed
- Presence of draining (that is, functioning) stoma or ostomyRegistry-derived · unreviewed
- 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 preclude or confound the ability to use efficacy assessment tools (such as CDAI) to assess response to study interventionRegistry-derived · unreviewed
- Currently has or is suspected of having an abscessRegistry-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
Co-Primary: Percentage of Participants with Clinical Remission at Week 48
Time frame: At Week 48
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than (\<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Primary outcome
Co-Primary: Percentage of Participants with Endoscopic Remission at Week 48
Time frame: At Week 48
Endoscopic remission is defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of less than or equal to (\<=) 4 with at least a 2-point reduction from baseline and no subscore greater than (\>) 1 in any individual component. The SES-CD is based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
Secondary outcome
Percentage of Participants with Deep Remission at Week 48
Time frame: At Week 48
Deep remission (composite endpoint) is defined as achieving both clinical remission and endoscopic remission at Week 48 at the participant level. Clinical remission is defined as a CDAI score of \<150 and Endoscopic remission is defined as a SES-CD score of \<= 4 with at least a 2-point reduction from baseline and no subscore \>1 in any individual component. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
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 at Week 48 is defined as clinical remission at Week 48 and not receiving corticosteroids for at least 90 days prior to Week 48. Clinical remission is defined as a CDAI score of \<150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Secondary outcome
Percentage of Participants with Corticosteroid-Free (90-day) PRO-2 Remission at Week 48
Time frame: At Week 48
Corticosteroid-free (90-day) patient-reported outcome(s) (PRO-2) remission at Week 48 is defined as an abdominal plan (AP) mean daily score less than or equal to (\<=) 1 and stool frequency (SF) mean daily score \<= 2.8, and no worsening of AP or SF from baseline, and not receiving corticosteroids for at least 90 days prior to Week 48.
Secondary outcome
Percentage of Participants with Sustained Clinical Remission
Time frame: At Weeks 12 and 48
Sustained clinical remission is defined as clinical remission at Week 12 and Week 48. Clinical remission is defined as CDAI score of \<150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Secondary outcome
Percentage of Participants with Histologic-Endoscopic Remission at Week 48
Time frame: At Week 48
Histologic-endoscopic remission at week 48 is defined as achieving a combination of histologic remission and endoscopic remission at Week 48. Histologic remission is defined as absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, or ulcerations or granulation tissue as assessed by the Robarts Histopathology Index. Endoscopic remission is defined as a SES-CD score of \<= 4 with at least a 2-point reduction from baseline and no subscore \> 1 in any individual component.
Secondary outcome
Percentage of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Response at Week 48
Time frame: At Week 48
IBDQ response at Week 48 is defined as an improvement of at least 16 points in the IBDQ total score from baseline at Week 48. IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate disease-specific health related quality of life (HRQoL) across 4 dimensional scores: bowel symptoms (loose stools, AP), systemic function (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.
Secondary outcome
Percentage of Participants with Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) Mental Component Summary Score (MCS) Response at Week 48
Time frame: At Week 48
PROMIS-29 MCS response at Week 48 is defined as an improvement of at least 7 points in PROMIS-29 MCS score from baseline 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). PROMIS-29 also includes an overall average pain intensity 0-10 numeric rating scale. 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 with Clinical Remission at Week 12
Time frame: At Week 12
Clinical remission at Week 12 is defined as CDAI score \<150 at Week 12. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Secondary outcome
Percentage of Participants with Endoscopic Response at Week 12
Time frame: At Week 12
Endoscopic response at Week 12 is defined as greater than (\>) 50 percent (%) improvement from baseline in SES-CD score at Week 12 or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
Secondary outcome
Number 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
Atlanta Gastroenterology Specialists
RecruitingSuwanee, Georgia, 30024, 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
This study also lists 43 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- May 11, 2026
- Primary completion
- Jun 12, 2028
- Overall completion
- Jul 12, 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.