Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
The trial is testing risankizumab alone and in combination with investigational ABBV antibodies for moderate-to-severe Crohn’s disease and ulcerative colitis — findings could inform future treatment choices and combination strategies.
Adults with moderately to severely active Crohn's disease or ulcerative colitis; patients on biologics; IBD clinicians and researchers interested in new biologic combinations.
What To Know
This registered Phase 2 platform (basket) trial is testing combinations and monotherapies including risankizumab plus two investigational ABBV antibodies in adults with moderately to severely active Crohn's disease or ulcerative colitis. Results from this study could affect future treatment options for people with moderate-to-severe IBD.
This is a multiarm, two-substudy Phase 2 interventional trial run by AbbVie that will enroll adults with moderately to severely active Crohn's disease or ulcerative colitis.
Substudy 1 and Substudy 2 each compare risankizumab alone and in combination with investigational antibodies (trosunilimab / ABBV-701) across blinded treatment arms after an initial unblinded substudy assignment.
The study plans frequent clinic visits with medical assessments, blood and stool tests, endoscopies, and patient questionnaires; participants may face greater time and testing burden than standard care.
Primary outcomes include endoscopic remission measured at Week 28 for Crohn's and UC-specific eligibility/stratification criteria are described in the record.
Adults with moderately to severely active Crohn's disease or ulcerative colitis, patients currently on or considering biologic therapy, IBD clinicians, and clinical researchers following new biologic and combination strategies. This is a trial record (Phase 2, not yet recruiting) and does not report results.
Some agents listed are investigational combinations; enrollment, design details, and outcomes should be reviewed on the clinicaltrials.gov page and discussed with a treating clinician before considering participation.
This is a Phase 2 interventional study record (not yet recruiting) and contains study design and planned outcomes but no clinical results. Investigational agents and combination strategies are under study; participation may involve higher visit and testing burden than standard care.
