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New treatment option 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?
Risankizumab is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for crohn's disease.
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
- Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss.
- 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. TaTs include biologics and/or targeted...
You likely can't join if
- Participant who demonstrated intolerance to p19 inhibitors, including risankizumab.
- Participant who received any investigational TaT (or TaT that becomes approved during the conduct of the study) within 30 days or 5 half-lives prior...
- Participant who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current...
The study team makes the final eligibility decision.
Where it's taking place
- Dothan, Alabama, United States
- Mobile, Alabama, United States
- Coronado, California, United States
- La Jolla, California, United States
- Sacramento, California, United States
- San Diego, 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
+ 198 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dothan, Alabama, United States; Mobile, Alabama, United States; Coronado, California, United States; La Jolla, California, United States; Sacramento, California, United States; San Diego, California, United States and 212 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.