Clinical trial for Crohn's Disease
Official title Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
ClinicalTrials.gov ID: NCT06548542
What this study is testing
What is Risankizumab?
This is an investigational medicine being studied as a potential treatment for Crohn's disease. It is designed to block a specific protein in the body that causes inflammation.
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 wants to see how well four targeted therapies work and what side effects they may cause in adults with moderate to severe Crohn's disease.
- Who it's for
- Adults who have moderate to severe Crohn's disease and are willing to try new treatments.
- What's involved
- Participants will receive one of the four medicines, either injections under the skin or infusions into a vein, according to a random assignment. They will visit a hospital or clinic regularly for medical checks, blood tests, endoscopies, side‑effect monitoring, questionnaires, and a daily diary.
- Time commitment
- The study lasts about a year, with regular clinic visits and tests scheduled throughout that time.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Participants' body weight must be \>= 40 kg at Baseline.
- Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by...
- CDAI \>= 220 at Baseline.
- Endoscopic evidence of mucosal inflammation as documented by an SES-CD of \>= 6 for ileocolonic or colonic disease or SES-CD of \>= 4 for isolated...
- Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and/or TaTs.
You likely can't join if
- Participant with history of intolerance to p19 inhibitors, including risankizumab.
- Participant who have any of the following: Current diagnosis of UC or indeterminate colitis.
The study team makes the final eligibility decision.
Where it is enrolling
- Dothan, Alabama, United States
- Mobile, Alabama, United States
- Coronado, California, United States
- La Jolla, California, United States
- Sacramento, California, United States
- Colorado Springs, Colorado, United States
- Danbury, Connecticut, United States
- New Haven, Connecticut, United States
- Clermont, Florida, United States
- Gainesville, Florida, United States
- Inverness, Florida, United States
- Margate, Florida, United States
- Miami, Florida, United States
- New Port Richey, Florida, United States
- Orange City, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Zephyrhills, Florida, United States
- Macon, Georgia, United States
- Boise, Idaho, United States
+ 180 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 to 75 years. 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; Coronado, California, United States; La Jolla, California, United States; Sacramento, California, United States; Colorado Springs, Colorado, United States and 194 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.