Crohn Disease
Guselkumab Versus Risankizumab for Active Crohn’s Disease
This phase 3 study is comparing how well guselkumab and risankizumab work in adults with moderately to severely active Crohn’s disease.
Registry title: A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
30 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years and older
- Treatment
- Guselkumab or Risankizumab
- Design
- Randomized
- Central study contact
- Study Contact844-434-4210Participate-In-This-Study1@its.jnj.com
- Sponsor
- Janssen Research & Development, LLC
Research question
How do guselkumab and risankizumab compare in efficacy and safety when used to treat 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 with Crohn’s disease, including fistulizing Crohn’s disease, diagnosed for at least 12 weeks.
- The study is looking for people whose Crohn’s disease is moderately to severely active based on specified symptom and endoscopy scores.
- The study is looking for people with Crohn’s disease affecting the colon, ileum, or both.
Participation overview
What participation may involve
Participants are randomly assigned to receive either guselkumab or risankizumab on the study’s reported induction and maintenance schedules. What participation may involve: - Receive guselkumab by injection under the skin or receive risankizumab first by intravenous infusion and later by injection under the skin. - Provide information used to calculate the Crohn’s Disease Activity Index, including symptoms, general well-being, weight, hematocrit, and medication use. - Undergo endoscopic assessment of Crohn’s disease activity using the Simple Endoscopic Score for Crohn’s Disease. - Have hematology and chemistry laboratory results monitored and adverse events recorded. The reported study-drug schedules continue through Week 52; the registry does not state each participant’s complete participation duration. Study-drug administration is reported at Weeks 0, 4, and 8, followed by maintenance dosing beginning at Week 12, but the full visit schedule is not provided.
Study interventions
What participants may receive or do
- Guselkumab: Participants assigned to guselkumab receive injections under the skin at Weeks 0, 4, and 8, followed by injections every 4 weeks from Week 12 through Week 52.
- Risankizumab: Participants assigned to risankizumab receive intravenous infusions at Weeks 0, 4, and 8, followed by injections under the skin every 8 weeks from Week 12 through Week 52.
Study design
How the comparison works
This is a phase 3, parallel-group study in which participants are assigned to guselkumab or risankizumab and both groups are followed for efficacy and safety. Participants are assigned to a treatment group at random; the registry does not report the assignment ratio. The study is open-label, meaning the registry reports no masking of treatment assignment. Risankizumab serves as the active treatment comparison for guselkumab. No placebo group is described; the two reported groups receive guselkumab or risankizumab.
Reported activities
Procedures and tests
- Screening endoscopy with central review is used to confirm the required level of active ileal or colonic Crohn’s disease.
- Crohn’s Disease Activity Index assessments collect information on stool frequency, abdominal pain or cramping, general well-being, weight, hematocrit, abdominal mass, symptoms outside the intestine, and use of antidiarrheal drugs or opioids.
- Endoscopic disease activity is assessed with the Simple Endoscopic Score for Crohn’s Disease.
- Hematology and chemistry laboratory parameters are monitored.
- Adverse events, serious adverse events, and events leading to discontinuation of study treatment are recorded.
- Guselkumab is administered by injection under the skin.
- Risankizumab is administered first by intravenous infusion and later by injection under the skin.
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 present for at least 12 weeks and previously confirmed by radiography, histology, or endoscopy.
- The baseline Crohn’s Disease Activity Index score must be from 220 through 450.
- Screening endoscopy must show active ileal or colonic Crohn’s disease meeting the specified Simple Endoscopic Score and ulceration requirements.
- The investigator must consider the person’s disease appropriate for the maintenance dosing schedules used in this study.
- Participants must follow the protocol’s requirements for other Crohn’s disease medications.
Possible reasons someone may not be able to join
- Certain Crohn’s disease complications are excluded, including symptomatic narrowing, short gut syndrome, an actively draining stoma, significant fistulizing disease, or another manifestation expected to require surgery within the next year or interfere with study assessments.
- A current or suspected abscess is exclusionary.
- An active fistula during screening or at Week 0 is excluded if surgery is expected to be needed.
- Bowel resection within 24 weeks, or another intra-abdominal or major surgery within 12 weeks, before the first study dose is exclusionary.
- A current malignancy or malignancy within the five years before screening is exclusionary.
Important unknowns
What the record does not make clear
- The registry gives study-drug dosing weeks but does not provide the complete schedule or number of in-person visits.
- Dosing is described through Week 52, while some outcomes are assessed later, but each participant’s total time in the study is not stated.
- Participants must follow protocol requirements for other Crohn’s disease medications, but those requirements are not included in the registry record.
- The registry does not report whether any medicines must be stopped for a specified period before treatment begins.
- The registry does not describe what treatment is available if Crohn’s disease worsens during the study.
- A screening endoscopy is required and Week 52 outcomes include endoscopic measures, but the complete endoscopy schedule and preparation requirements are not stated.
- The registry does not state which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants receive compensation.
- The registry does not report reimbursement or support for transportation, lodging, or meals.
- The registry does not state whether any visits or assessments may be completed remotely.
- The registry does not describe access to assigned treatment after study participation ends.
- The study is recruiting overall and many listed sites are recruiting, but one listed site is suspended and site status can change.
Before contacting the site
Questions for the study team
- What is the complete visit schedule, and which visits require travel to the study site?
- How many endoscopies are required, and when will they occur?
- Which current Crohn’s disease medicines can continue, and are any washout periods required?
- What happens if Crohn’s disease worsens during the study, and what rescue treatment is allowed?
- Which study-related costs are covered, and are compensation or travel support available?
- How long does follow-up continue after Week 52, and what activities occur during that period?
- Is the nearest listed site currently enrolling, and can any assessments be completed remotely?
Before changing care
Questions for your gastroenterologist
- How might the study’s rules affect my current Crohn’s disease medicines, including steroids or other advanced therapies?
- Is my disease stable enough to consider screening, including the required endoscopy and possible treatment transition?
- How do guselkumab and risankizumab fit among approved treatment alternatives for my clinical history?
- What risks or monitoring concerns should the research team know about from my disease complications, surgeries, infections, or cancer history?
- How should my regular gastroenterology care be coordinated with the study team if I pursue screening?
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 guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).
Study design and administration
- Organization
- Janssen Research & Development, LLC
- Organization class
- Industry
- Organization study ID
- CNTO1959CRD3009
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Guselkumab
Participants will receive guselkumab induction dose subcutaneously (SC) at Weeks 0, 4, and 8 followed by guselkumab maintenance dose SC once every 4 weeks (q4w) from Week 12 through Week 52.
Interventions: Drug: Guselkumab
Experimental
Risankizumab
Participants will receive risankizumab induction dose intravenously (IV) at Weeks 0, 4, and 8 followed by risankizumab maintenance dose SC once every 8 weeks (q8w) from Week 12 through Week 52.
Interventions: Drug: Risankizumab
Interventions
Drug
Guselkumab
Guselkumab will be administered.
Drug
Risankizumab
Risankizumab will be administered.
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (7)
- Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopyRegistry-derived · unreviewed
- Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\>=) 220 but less than or equal to (\<=) 450Registry-derived · unreviewed
- Baseline endoscopic evidence of active ileal and/or colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening Simple Endoscopic Score for Crohn's Disease (SES CD) \>= 4 (for participants with isolated ileal disease) or \>= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores:Registry-derived · unreviewed
- a minimum score of 1 for the component of "size of ulcers" ANDRegistry-derived · unreviewed
- a minimum score of 1 for the component of "ulcerated surface"Registry-derived · unreviewed
- In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing regimens utilized in the studyRegistry-derived · unreviewed
- Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocolRegistry-derived · unreviewed
Exclusion criteria (5)
- Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or any other manifestation anticipated to require surgery within the next year, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab or risankizumabRegistry-derived · unreviewed
- Currently has or is suspected to have an abscessRegistry-derived · unreviewed
- Has an active fistula during screening or at Week 0 with an anticipated need for surgeryRegistry-derived · unreviewed
- Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks, before first dose of study interventionRegistry-derived · unreviewed
- Currently has a malignancy or has a history of malignancy within 5 years before screeningRegistry-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
Number of Participants with Deep Remission at Week 52
Time frame: At Week 52
Deep remission is a composite endpoint defined as achieving both clinical remission and endoscopic remission at the participant level. Clinical remission is defined as Crohn's Disease Activity Index (CDAI) score less than (\<) 150-point. CDAI will be assessed by collecting information on 8 different CD-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600. Higher score indicates higher disease activity. Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) less than or equal to (\<=) 4 with at least a 2-point reduction from baseline and no sub score greater than (\>) 1 in any individual component and score can range from 0 to 56. Higher scores indicating severe disease.
Secondary outcome
Composite Endpoint of Number of Participants with Clinical Remission and Endoscopic Response at Week 52
Time frame: At Week 52
Clinical remission is defined as CDAI score \< 150-point. CDAI will be assessed by collecting information on 8 different CD-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600. Higher score indicates higher disease activity. Endoscopic response is defined as \>50 percent (%) improvement from baseline in the SES CD or SES-CD score \<= 2 or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. This is a composite endpoint defined to measure achievement of both clinical remission and endoscopic response.
Secondary outcome
Number of Participants with Endoscopic Remission at Week 52
Time frame: At Week 52
Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \> 1 in any individual component and score can range from 0 to 56. Higher scores indicating severe disease.
Secondary outcome
Number of Participants with Clinical Remission at Week 52
Time frame: At Week 52
Clinical remission is defined as CDAI score \< 150-point. CDAI will be assessed by collecting information on 8 different CD-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600. Higher score indicates higher disease activity.
Secondary outcome
Number of Participants with Steroid-Free Clinical Remission at Week 52
Time frame: At Week 52
Steroid-free clinical remission is defined as clinical remission at Week 52 and not receiving corticosteroids for at least 90 days prior to Week 52. Clinical remission is defined as CDAI score \< 150-point.
Secondary outcome
Number of Participants with Abnormalities in Laboratory Parameters
Time frame: Up to Week 148
Number of participants with abnormalities in laboratory parameters (hematology and chemistry) will be reported.
Secondary outcome
Number of Participants With Change From Baseline in Laboratory Abnormalities
Time frame: Up to week 148
Number of participants with change from baseline in laboratory abnormalities (hematology and chemistry) will be reported.
Secondary outcome
Number of Participants with Adverse Events (AEs), Serious AEs and AEs Leading to Discontinuation of Study Intervention
Time frame: Up to Week 165
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. 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
Digestive Health Specialists of the Southeast
RecruitingDothan, Alabama, 36305, United States
East View Medical Research
RecruitingMobile, Alabama, 36608, United States
Clinnova Research
RecruitingAnaheim, California, 92805, United States
United Gastroenterologists
RecruitingLos Alamitos, California, 90720, United States
TLC Clinical Research Inc
RecruitingLos Angeles, California, 90048, United States
Medical Associates Research Group, Inc.
RecruitingSan Diego, California, 92123, United States
Peak Gastroenterology Associates
RecruitingColorado Springs, Colorado, 80907, United States
Medical Research Center of Connecticut
RecruitingHamden, Connecticut, 06518, United States
Green Leaf Clinical Trials
RecruitingJacksonville, Florida, 32258, United States
Biodax Medical Research Trials
RecruitingMiami, Florida, 33186, United States
Sanchez Clinical Research, Inc
RecruitingMiami, Florida, 33157-6575, United States
GI Pros Research
RecruitingNaples, Florida, 34102, United States
GCP Clinical Research
RecruitingTampa, Florida, 33609, United States
Morehouse School of Medicine
RecruitingAtlanta, Georgia, 30310, United States
Gastroenterology Associates of Central GA
RecruitingMacon, Georgia, 31201, United States
Cotton-O'Neil Clinical Research Center
RecruitingTopeka, Kansas, 66606, United States
Gastroenterology Clinic of Acadiana
RecruitingLafayette, Louisiana, 70503, United States
Michigan Center of Medical Research
RecruitingFarmington Hills, Michigan, 48334, United States
Westchester Putnam Gastroenterology
RecruitingCarmel, New York, 10512, United States
New York Gastroenterology Associates
RecruitingNew York, New York, 10075, United States
Charlotte Gastroenterology and Hepatology, PLLC
RecruitingCharlotte, North Carolina, 28207, United States
Great Lakes Gastroenterology Research, LLC
RecruitingMentor, Ohio, 44060, United States
Digestive Disease Specialists Inc
RecruitingOklahoma City, Oklahoma, 73114, United States
Frontier Clinical Research
RecruitingUniontown, Pennsylvania, 15401, United States
Palmetto Primary and Specialty Care Physicians, Charleston
RecruitingSummerville, South Carolina, 29486, United States
DFW Clinical Trials
RecruitingCarrollton, Texas, 75010, United States
Lubbock Gastroenterology
RecruitingLubbock, Texas, 79424, United States
Gastroenterology Research of America, LLC
RecruitingSan Antonio, Texas, 78229, United States
Southern Star Research Institute, LLC
RecruitingSan Antonio, Texas, 78229, United States
The University of Texas Health Science Center at Tyler
RecruitingTyler, Texas, 75708, United States
This study also lists 113 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Mar 30, 2026
- Primary completion
- Nov 15, 2028
- Overall completion
- Dec 11, 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.