Crohn Disease study: Guselkumab vs Risankizumab
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?
An investigational injectable medicine being studied for moderately to severely active Crohn's 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 study compares how well the drug guselkumab works against risankizumab in people with active Crohn's disease.
- Who it's for
- People with moderately to severely active Crohn's disease.
- What's involved
- Participants will receive either guselkumab or risankizumab and will have regular visits and tests to monitor their condition.
- Time commitment
- The study lasts several months and requires multiple clinic visits for treatment and monitoring.
- 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...
- 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
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
- 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 is enrolling
- Dothan, Alabama, United States
- Mobile, Alabama, United States
- Anaheim, California, United States
- Lancaster, California, United States
- Los Alamitos, California, United States
- Los Angeles, 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
- Naples, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Macon, Georgia, United States
- Northbrook, Illinois, United States
- Clive, Iowa, United States
- Topeka, Kansas, United States
- Lafayette, Louisiana, United States
+ 117 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, but 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?
This study is enrolling now at Dothan, Alabama, United States; Mobile, Alabama, United States; Anaheim, California, United States; Lancaster, California, United States; Los Alamitos, California, United States; Los Angeles, California, United States and 131 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.