RightFit
RecruitingPhase 2

Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease

A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease

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: Infusions, Injections, 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
  • "Risankizumab and trosunilimab are given as an injection under the skin or as an infusion into the vein."
  • "Lutikizumab is given as an injection under the skin."
  • "ABBV-8736 is given as an infusion into the vein."
  • "The effect of the treatment will be checked by medical assessments, blood 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 well risankizumab, trosunilimab, lutikizumab, and ABBV-8736 work and what side effects they cause. It is for adults with moderate to severe Crohn’s disease, which causes swelling in the digestive tract. Participants are assigned by chance to an available treatment group.

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD. The medicines assessed in this study are risankizumab, trosunilimab, lutikizumab, and ABBV-8736. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 590 participants will be enrolled in the study at approximately 300 sites worldwide. Risankizumab and trosunilimab are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. ABBV-8736 is given as an infusion into the vein. 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, 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

  • Weigh at least 40 kilograms (about 88 pounds) at the start of the study.
  • Have confirmed Crohn’s disease for at least 3 months, with tissue sample results that support the diagnosis.
  • Have a Crohn’s Disease Activity Index (CDAI) score of at least 220. This score measures disease activity.
  • Have swelling in the bowel seen during an endoscopy, a test using a camera. The required SES-CD score is at least 6, or at least 4 if only the last part of the small bowel is affected. Bowel narrowing does not count toward this score.
  • Have tried targeted treatments that did not work well enough or caused side effects you could not tolerate. Outside the United States, standard treatments may also meet this requirement.

Who can't join

  • Have had side effects you could not tolerate from p19 inhibitors, a group of medicines that includes risankizumab.
  • Currently have ulcerative colitis or indeterminate colitis, other types of bowel inflammation.
  • Currently have an ostomy, a bowel opening made through the belly, or an ileoanal pouch, an internal pouch made from the small bowel.
  • Currently have short bowel syndrome, a condition caused by having too little working bowel.
  • Had surgery to remove part of the bowel within 3 months before the study starts.

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

Official eligibility criteria

Inclusion Criteria: * Participants' body weight must be \>= 40 kg at Baseline. * Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available. * CDAI \>= 220 at Baseline. * Endoscopic evidence of mucosal inflammation as documented by an SES-CD of \>= 6 for ileocolonic or colonic disease or SES-CD of \>= 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader. * Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and/or TaTs. TaTs include biologics and/or targeted small molecules. Exclusion Criteria: * Participant with history of intolerance to p19 inhibitors, including risankizumab. * Participant who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline.

Study sites (64)

AL

CA

CO

CT

FL

GA

ID

IL

IN

KY

MA

MD

MI

MN

MO

NC

NV

NY

OH

OK

PA

SC

TN

TX

UT

WA