Study of Advanced Therapies for Crohn's Disease or Ulcerative Colitis
This study is looking at new treatments for adults with moderately to severely active Crohn's disease (CD) or ulcerative colitis (UC). These are types of inflammatory bowel disease that cause long-lasting inflammation in your digestive tract. The study will test the safety and effectiveness of advanced therapies, including risankizumab, trosunilimab, and ABBV-701. Researchers want to see if these treatments can help you achieve endoscopic remission (meaning the inflammation in your digestive tract looks better during an endoscopy). They will also track any side effects. You may be able to join if you are between 18 and 75 years old and have a confirmed diagnosis of CD or UC with specific levels of disease activity.
- Study design
- This interventional study plans to enroll 2000 participants. It is a platform basket study evaluating different treatments in substudies.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure adverse events for up to 98 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
At a glance
Conditions
NCT07697456
Where you'd take part
This study runs at 32 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Advanced Research Institute, Inc /ID# 281062
New Port Richey, Floridastudy coordinator listed
Recruiting
Elite Clinical Studies /ID# 280477
Phoenix, Arizonastudy coordinator listed
Recruiting
Gastroenterology Consultants - Roswell /ID# 281235
Roswell, Georgiastudy coordinator listed
Recruiting
Research Associates of South Florida /ID# 280929
Miami, Floridastudy coordinator listed
Recruiting
The Vancouver Clinic /ID# 280497
Vancouver, Washingtonstudy coordinator listed
Recruiting
Willis-Knighton Medical Center /ID# 280572
Shreveport, Louisianastudy coordinator listed
Recruiting
Amel Med /ID# 283864
Georgetown, Texasno site contact published
Recruiting
China Medical University Hospital /ID# 280630
Taichung, Taiwanno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- ABBVIE INC. · STUDY_DIRECTOR · AbbVie
Who to contact
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Inclusion
Exclusion
What this trial measures
- Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic RemissionAt Week 28
Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) \<= 4 and no sub score greater than 1 in any individual variable, as scored by a central reviewer.
- Ulcerative Colitis Specific: Percentage of Participants who Achieve Endoscopic RemissionAt Week 28
Endoscopic remission is defined as Mayo Endoscopic Subscore (ESS) of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal appearance of mucosa; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
- Number of Participants with Adverse Events (AEs)Up to 98 Weeks
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.