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.

NCT07697456

Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis

Recruiting
PHASE2Ages 18–75InterventionalTreatment
AbbVie
~2,000 participants
Updated 2026-09-15 on ClinicalTrials.gov
What's tested:RisankizumabTrosunilimabABBV-701

At a glance

Recruiting sites
32 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission
Measured over At Week 28
+2 more outcomes measured
Crohn's Disease
Ulcerative Colitis

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.

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

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Eligibility criteria

Inclusion

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
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

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
Participants with \>3 prior bowel resections
Participants with previous small bowel resection(s) of combined length \>100 cm
Participants with prior colectomy (total or subtotal)
Participants with extent of disease limited to \< 10 cm of rectum
  • 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.