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 540 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
540
Subcutaneous Injection
Subcutaneous Injection
Intravenous Infusion
Intravenous Infusion
Subcutaneous Injection
Intravenous Infusion
Digestive Health Specialists /ID# 266216
Dothan, Alabama, United States
RECRUITINGEast View Medical Research /ID# 270377
Mobile, Alabama, United States
RECRUITINGSouthern California Res. Ctr /ID# 265549
Coronado, California, United States
RECRUITINGUC San Diego Health System /ID# 265565
La Jolla, California, United States
Percentage of Participants who Achieve Endoscopic Remission
The Simple Endoscopic Score for Crohn's Disease (SES-CD) assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic Remission is defined as SES-CD ≤ 4 and no sub score greater than 1 in any individual variable, as scored by a central reader.
Time frame: Week 12
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time frame: Up to approximately 96 weeks
Percentage of Participants who Achieve Endoscopic Response
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic Response is defined as a decrease in SES-CD ≥ 50% from Baseline, as scored by central reader.
Time frame: Week 12
Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS)
SF/APS clinical remission is defined as the average daily SF ≤ 2.8 and not worse than Baseline AND average daily AP score ≤ 1 and not worse than Baseline.
Time frame: Week 12
Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI)
The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150
Time frame: Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
uc davis medical center - patient support services building /ID# 265554
Sacramento, California, United States
RECRUITINGClinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391
San Diego, California, United States
RECRUITINGPeak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557
Colorado Springs, Colorado, United States
RECRUITINGDanbury Hospital, Western Connecticut Health Network /ID# 265556
Danbury, Connecticut, United States
RECRUITINGYale University School of Medicine /ID# 266786
New Haven, Connecticut, United States
RECRUITINGNovum Research /ID# 278128
Clermont, Florida, United States
RECRUITING...and 245 more locations