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New treatment option for Crohn Disease
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, given as an once-daily pill taken by mouth, 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 purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) 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
- 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's taking place
- Chandler, Arizona, United States
- Litchfield Park, Arizona, United States
- Scottsdale, Arizona, United States
- Anaheim, California, United States
- Canoga Park, 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
- Danbury, Connecticut, United States
- Cutler Bay, Florida, United States
- Inverness, Florida, United States
- Jacksonville, Florida, United States
- Lakewood Rch, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
+ 269 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 Chandler, Arizona, United States; Litchfield Park, Arizona, United States; Scottsdale, Arizona, United States; Anaheim, California, United States; Canoga Park, California, United States; Coronado, California, United States and 283 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.