Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
Sponsored by AbbVie
About this study
Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss. UC affects the lining of the rectum and colon (large intestine) and can cause bleeding, belly pain, and diarrhea. This platform basket study will evaluate how safe and effective advanced therapies are in adults with moderately to severely active Crohn's Disease (CD) or Ulcerative Colitis (UC). This study currently includes 2 substudies evaluating different treatments in participants with CD or UC. Substudy 1 will evaluate the combination of risankizumab and trosunilimab (ABBV-466) and Substudy 2 will evaluate the combination of risankizumab and ABBV-701 (ABBV-7066). When adult participants with moderately to severely active CD or UC join the study, they will undergo a 2-step randomization within CD and UC substudies, respectively. The first unblinded randomization will assign participants into a substudy, and the second blinded randomization will assign participants to a treatment arm within the assigned substudy. Approximately 100 adult participants will be enrolled per treatment arm across both substudies at approximately 400 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, stool tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.
Where this study is enrolling (9)
- I'm interested
Elite Clinical Studies /ID# 280477
Phoenix, Arizona
- Call 727-835-3261
Advanced Research Institute, Inc /ID# 281062
New Port Richey, Florida
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 786-476-8790
Research Associates of South Florida /ID# 280929
Miami, Florida
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 404-596-4480
Gastroenterology Consultants - Roswell /ID# 281235
Roswell, Georgia
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 224-441-2217
Illinois Gastroenterology Group /ID# 283933
Gurnee, Illinois
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
Show all 9 locations
- Call 318-212-2863
Willis-Knighton Medical Center /ID# 280572
Shreveport, Louisiana
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call (828) 254-0881
Digestive Health Partners /ID# 280490
Asheville, North Carolina
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 832-234-1023
Center for Digestive Disease /ID# 280870
Shenandoah, Texas
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 360-397-3388
The Vancouver Clinic /ID# 280497
Vancouver, Washington
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
Who can participate
Inclusion criteria
- ✓CD specific:
- ✓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.
- ✓Demonstrated failure of 1 or more therapy for CD
- ✓UC specific:
- ✓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
Exclusion criteria
- ✕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 surgical bowel resection within the past 3 months prior to Baseline
- ✕CD specific:
- ✕Participants with \>3 prior bowel resections
- ✕Participants with previous small bowel resection(s) of combined length \>100 cm
- ✕UC specific:
- ✕Participants with prior colectomy (total or subtotal)
- ✕Participants with extent of disease limited to \< 10 cm of rectum
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.