Clinical trial for Crohn's Disease
Official title Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
ClinicalTrials.gov ID: NCT07697456
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 in the digestive tract.
Also referred to as ABBV-066.
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
- This study is testing whether two new drug combinations work well. It also checks how safe these treatments are for people with active bowel disease.
- Who it's for
- You may be able to join if you are an adult with active Crohn's disease or ulcerative colitis.
- What's involved
- You would get one of two new drug combinations. You would also take part in blood tests, stool tests, and gut scans.
- Time commitment
- You would need to visit a clinic regularly for the length of the study.
- Phase 2: a mid-size study of how well it works
- This is a blinded 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 to 75
You may be able to join if
- Crohn's Disease Activity Index (CDAI) score of ≥ 220
- Confirmed diagnosis of CD at least 90 days prior to Baseline
- Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 6 for ileocolonic or...
- Confirmed diagnosis of UC at least 90 days prior to Baseline
- Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3
You likely can't join if
- Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab)
- Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first...
- Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame
- Participants with \>3 prior bowel resections
- Participants with prior colectomy (total or subtotal)
- Participants with extent of disease limited to \< 10 cm of rectum
See the full eligibility criteria
- Crohn's Disease Activity Index (CDAI) score of ≥ 220
- Confirmed diagnosis of CD at least 90 days prior to Baseline
- Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease.
- Confirmed diagnosis of UC at least 90 days prior to Baseline
- Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3
- Demonstrated failure of 1 or more therapy for UC
- Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab)
- Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first dose of study treatment
- Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame
- Participants with \>3 prior bowel resections
- Participants with prior colectomy (total or subtotal)
- Participants with extent of disease limited to \< 10 cm of rectum
The study team makes the final eligibility decision.
Where it is enrolling
- Dothan, Alabama, United States
- Phoenix, Arizona, United States
- Sun City, Arizona, United States
- Anaheim, California, United States
- Coronado, California, United States
- Lancaster, California, United States
- Los Alamitos, California, United States
- Rialto, California, United States
- Colorado Springs, Colorado, United States
- Bradenton, Florida, United States
- Kissimmee, Florida, United States
- Largo, Florida, United States
- Miami, Florida, United States
- New Port Richey, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Macon, Georgia, United States
- Roswell, Georgia, United States
- Boise, Idaho, United States
- Des Plaines, Illinois, United States
+ 45 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; Phoenix, Arizona, United States; Sun City, Arizona, United States; Anaheim, California, United States; Coronado, California, United States; Lancaster, California, United States and 59 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.