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

Description

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, 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.

Conditions

Crohn's Disease

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Study Overview

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Study Details

Study overview

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, 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.

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

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

Condition
Crohn's Disease
Intervention / Treatment

-

Contacts and Locations

Dothan

Digestive Health Specialists /ID# 266216, Dothan, Alabama, United States, 36301

Mobile

East View Medical Research /ID# 270377, Mobile, Alabama, United States, 36606

San Diego

Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391, San Diego, California, United States, 92103

Colorado Springs

Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557, Colorado Springs, Colorado, United States, 80907

Inverness

Nature Coast Clinical Research - Inverness /ID# 265874, Inverness, Florida, United States, 34452-4717

Miami

A Plus Research /ID# 265878, Miami, Florida, United States, 33144

Miami

Sanchez Clinical Research /ID# 265887, Miami, Florida, United States, 33157

New Port Richey

Advanced Research Institute, Inc /ID# 265548, New Port Richey, Florida, United States, 34653

Orange City

Hillcrest Medical Research, LLC /ID# 267237, Orange City, Florida, United States, 32763

Orlando

Endoscopic Research, Inc. /ID# 267211, Orlando, Florida, United States, 32803

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AbbVie,

ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

2028-08