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

Research Study on Targeted Therapies for Moderate to Severe Crohn's Disease

M
Monika Fischer, MD

Primary Investigator

Enrolling By Invitation
18 years - 75 years
All
Phase 2
2 participants needed
1 Location

Brief description of study

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

The medicines assessed in this study are risankizumab, ABBV-382 and lutikizumab. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 500 participants will be enrolled in the study at approximately 300 sites worldwide.

Risankizumab and ABBV-382 are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. Each group includes a 12-week induction period, a 12-week maintenance period, and an optional long-term extension period where medication will be given after the maintenance period.

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Crohn's Disease
  • Age: 18 years - 75 years
  • Gender: All

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 TaTs including biologics

Exclusion Criteria:

  • Participant who demonstrated intolerance to p19 inhibitors, including risankizumab.
  • Participant who received any investigational TaT (or TaT that becomes approved during the conduct of the study) within 30 days or 5 half-lives prior to Baseline, whichever is longer. Note: If there is documentation of an undetectable (or below the lower limit of quantification/quantitation) drug level measured by a commercially available assay for any of the approved biologics above, there is no minimum washout prior to Baseline.
  • 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.

This study investigates targeted therapies for adults with moderate to severe Crohn's disease. Crohn's disease is a long-lasting condition that causes inflammation in the digestive tract, often affecting the bowels. Symptoms can include belly pain, diarrhea, tiredness, and weight loss. The study aims to evaluate the effectiveness and possible side effects of these therapies in treating the disease.

Participants will be randomly assigned to receive different investigational medications. Treatments include injections under the skin or infusions into the vein. The study includes a 12-week induction period, a 12-week maintenance period, and an optional long-term extension period. Participants will undergo medical assessments, blood tests, endoscopies, and will be asked to complete questionnaires and a daily diary to monitor the effects of the treatment.

  • Who can participate: Adults with Crohn's disease for at least 3 months, weighing at least 40 kg, with specific endoscopic evidence of mucosal inflammation, and inadequate response to targeted therapies can participate.
  • Study details: Participants will receive investigational medications either as injections or infusions, attending regular visits for assessments and tests.
Updated on 09 Apr 2026. Study ID: GI-ABBVIE-M24-885-TARGET-CD, 28790
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only