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Compares treatment options for Crohn Disease
Official title A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov ID: NCT07499232
What this study is testing
What is Guselkumab?
Guselkumab is an investigational medicine, being studied as a potential treatment for crohn disease.
Also referred to as CNTO1959.
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 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).
- 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
- 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...
- Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\>=) 220 but less...
- Baseline endoscopic evidence of active ileal and/or colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a...
- a minimum score of 1 for the component of "size of ulcers" AND
- a minimum score of 1 for the component of "ulcerated surface"
You likely can't join if
- Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or...
- Currently has or is suspected to have an abscess
- Has an active fistula during screening or at Week 0 with an anticipated need for surgery
- 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...
- Currently has a malignancy or has a history of malignancy within 5 years before screening
See the full eligibility criteria
- 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 endoscopy
- 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 (\<=) 450
- 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...
- a minimum score of 1 for the component of "size of ulcers" AND
- a minimum score of 1 for the component of "ulcerated surface"
- In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing regimens utilized in the study
- Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocol
- 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...
- Currently has or is suspected to have an abscess
- Has an active fistula during screening or at Week 0 with an anticipated need for surgery
- 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 intervention
- Currently has a malignancy or has a history of malignancy within 5 years before screening
The study team makes the final eligibility decision.
Where it's taking place
- Dothan, Alabama, United States
- Mobile, Alabama, United States
- Anaheim, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- San Diego, California, United States
- Colorado Springs, Colorado, United States
- Hamden, Connecticut, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Macon, Georgia, United States
- Topeka, Kansas, United States
- Lafayette, Louisiana, United States
- Carmel, New York, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Mentor, Ohio, United States
- Oklahoma City, Oklahoma, United States
+ 72 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 Dothan, Alabama, United States; Mobile, Alabama, United States; Anaheim, California, United States; Los Alamitos, California, United States; Los Angeles, California, United States; Newport Beach, California, United States and 86 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.