Crohn Disease study: Icotrokinra
Official title A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov ID: NCT07196722
What this study is testing
What is Icotrokinra?
Icotrokinra is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for crohn disease.
Also referred to as JNJ-77242113.
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 will see how well icotrokinra works and how safe it is for people with moderately to severely active Crohn's disease.
- Who it's for
- Adults who have moderately to severely active Crohn's disease.
- What's involved
- Participants will receive icotrokinra and undergo regular check‑ups and tests to monitor their health.
- 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
- Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a...
- Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score \>=220 but \ =4, or mean daily AP score \>=2
- Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as...
- A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-hCG) at screening and a negative...
- Demonstrated an inadequate response to, or failure to tolerate conventional therapy but naïve to advanced therapies (advanced drug therapy...
You likely can't join if
- Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while...
- Presence of a stoma or ostomy
- Participants with presence of active fistulas may be included if there is no surgery needed
- Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline
- Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization
The study team makes the final eligibility decision.
Where it is enrolling
- Chandler, Arizona, United States
- Litchfield Park, Arizona, United States
- Scottsdale, Arizona, United States
- Anaheim, California, United States
- Coronado, California, United States
- Lancaster, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Oxnard, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Colorado Springs, Colorado, United States
- Cutler Bay, Florida, United States
- Inverness, Florida, United States
- Lakewood Rch, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Macon, Georgia, United States
- Indianapolis, Indiana, United States
+ 273 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 Chandler, Arizona, United States; Litchfield Park, Arizona, United States; Scottsdale, Arizona, United States; Anaheim, California, United States; Coronado, California, United States; Lancaster, California, United States and 287 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.