Status:
RECRUITING
Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
Lead Sponsor:
AbbVie
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06548542
Start Date
September 4 2024
End Date
August 1 2028
Last Update
January 2 2026
Active Locations (252)
Enter a location and click search to find clinical trials sorted by distance.
1
Digestive Health Specialists /ID# 266216
Dothan, Alabama, United States, 36301
2
East View Medical Research /ID# 270377
Mobile, Alabama, United States, 36606
3
Southern California Res. Ctr /ID# 265549
Coronado, California, United States, 92118
4
UC San Diego Health System /ID# 265565
La Jolla, California, United States, 92037