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RecruitingPhase 2

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

A Phase 2 Platform Basket Study Evaluating Advanced Therapies in Subjects With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe and effective two drug combinations are for adults with moderately to severely active Crohn’s disease or ulcerative colitis. Both diseases cause lasting swelling in the digestive tract. The study tests risankizumab with either trosunilimab (ABBV-466) or ABBV-701 (ABBV-7066).

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • For Crohn’s disease: Your diagnosis was confirmed at least 90 days before the study’s starting visit.
  • For Crohn’s disease: Your disease activity score (CDAI) is at least 220.
  • For Crohn’s disease: A camera exam shows swelling in the bowel, with an SES-CD score of at least 6, or at least 4 if only the last part of the small bowel is affected.
  • For Crohn’s disease: At least one treatment has not worked.
  • For ulcerative colitis: Your diagnosis was confirmed at least 90 days before the study’s starting visit.
  • For ulcerative colitis: Your disease activity score (modified Mayo score) is 5 to 9, and your camera exam score is 2 to 3.
  • For ulcerative colitis: At least one treatment has not worked.

Who can't join

  • You could not tolerate risankizumab or another drug in the p19 IL-23 inhibitor group.
  • You took an experimental drug too close to your first study dose: within 30 days, or longer depending on how long the study drugs take to leave the body.
  • You received an advanced treatment, such as a biologic or small-molecule drug, within the time period not allowed by the study.
  • You had surgery to remove part of your bowel in the 3 months before the study’s starting visit.
  • For Crohn’s disease: You have had more than 3 surgeries to remove parts of your bowel.
  • For Crohn’s disease: You have had more than 100 cm of small bowel removed in total.
  • For ulcerative colitis: You have had all or most of your colon removed.
  • For ulcerative colitis: Your disease affects less than 10 cm of the rectum, the last part of the bowel.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (60)

AL

AZ

CA

CO

FL

GA

ID

IL

IN

KY

LA

MA

MI

MO

MS

NC

NV

NY

OH

RI

SC

TN

TX

VA

WA

WI