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New treatment option for Colitis, Ulcerative
Official title A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT07196748
What this study is testing
What is Icotrokinra?
Icotrokinra is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for colitis, ulcerative.
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 protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).
- 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 12 and older
You may be able to join if
- Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report...
- Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained...
- An endoscopy subscore greater than or equal to (\>=) 2 as obtained during central review of the screening video endoscopy
- Adolescent Participants: body weight must be \>= 40 kilograms (kg) at baseline (Week I-0)
- Adult female participants of childbearing potential and all adolescent female participants must have a negative highly sensitive serum pregnancy test...
You likely can't join if
- Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic...
- Presence of a stoma
- Presence or history of a fistula
- Colonic resection within 24 weeks before baseline or any other intra-abdominal or other major surgery performed within 12 weeks before baseline
- History of extensive colonic resection (that is, less than [\<] 30 centimeter [cm] of colon remaining) or colonic resection that could impair the use...
See the full eligibility criteria
- Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC
- Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy
- An endoscopy subscore greater than or equal to (\>=) 2 as obtained during central review of the screening video endoscopy
- Adolescent Participants: body weight must be \>= 40 kilograms (kg) at baseline (Week I-0)
- Adult female participants of childbearing potential and all adolescent female participants must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin [β-hCG]) at screening and a...
- Demonstrated an inadequate response to, or failure to tolerate conventional therapy but are naïve to advanced therapies (ADT naïve), or inadequate response to (that is, primary or secondary nonresponse) or failure to...
- Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study
- Presence of a stoma
- Presence or history of a fistula
- Colonic resection within 24 weeks before baseline or any other intra-abdominal or other major surgery performed within 12 weeks before baseline
- History of extensive colonic resection (that is, less than [\<] 30 centimeter [cm] of colon remaining) or colonic resection that could impair the use of disease severity assessments (for example Mayo Score) to assess...
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
- 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
- Hartford, Connecticut, United States
- Cutler Bay, Florida, United States
- Inverness, Florida, United States
- Lakewood Rch, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Macon, Georgia, United States
+ 280 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, 12 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; Coronado, California, United States; Lancaster, California, United States and 294 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.