Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease (NCT06548542) — Ireland Trial Details

Condition(s) studied

Crohn's Disease

Investigational drug(s) / intervention(s)

RisankizumabLutikizumabTrosunilimabRisankizumabTrosunilimabABBV-8736

Risankizumab: Subcutaneous Injection

Lutikizumab: Subcutaneous Injection

Trosunilimab: Intravenous Infusion

Risankizumab: Intravenous Infusion

Trosunilimab: Subcutaneous Injection

ABBV-8736: Intravenous Infusion

Study 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 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

No

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 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.

Primary outcome measure(s)

Percentage of Participants who Achieve Endoscopic Remission — Week 12
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.
Number of Participants with Adverse Events (AEs) — Up to approximately 96 weeks
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.

Trial sites (255)

Facility	City	Region	Status
Digestive Health Specialists /ID# 266216	Dothan	Alabama	Recruiting
East View Medical Research /ID# 270377	Mobile	Alabama	Recruiting
Southern California Res. Ctr /ID# 265549	Coronado	California	Recruiting
UC San Diego Health System /ID# 265565	La Jolla	California	Recruiting
uc davis medical center - patient support services building /ID# 265554	Sacramento	California	Recruiting
Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391	San Diego	California	Recruiting
Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557	Colorado Springs	Colorado	Recruiting
Danbury Hospital, Western Connecticut Health Network /ID# 265556	Danbury	Connecticut	Recruiting
Yale University School of Medicine /ID# 266786	New Haven	Connecticut	Recruiting
Novum Research /ID# 278128	Clermont	Florida	Recruiting
University of Florida College of Medicine /ID# 266930	Gainesville	Florida	Recruiting
Nature Coast Clinical Research - Inverness /ID# 265874	Inverness	Florida	Recruiting
Atlantic Medical Research /ID# 266207	Margate	Florida	Recruiting
A Plus Research /ID# 265878	Miami	Florida	Recruiting
Sanchez Clinical Research /ID# 265887	Miami	Florida	Recruiting
Advanced Research Institute, Inc /ID# 265548	New Port Richey	Florida	Recruiting
Hillcrest Medical Research, LLC /ID# 267237	Orange City	Florida	Recruiting
Endoscopic Research, Inc. /ID# 267211	Orlando	Florida	Recruiting
Gcp Clinical Research /ID# 278126	Tampa	Florida	Recruiting
AdventHealth Medical Group - Tampa - Bruce B Downs Boulevard /ID# 265538	Tampa	Florida	Recruiting
Florida Medical Clinic - Zephyrhills /ID# 267392	Zephyrhills	Florida	Recruiting
Gastroenterology Associates of Central Georgia /ID# 265547	Macon	Georgia	Recruiting
Treasure Valley Medical Research /ID# 267114	Boise	Idaho	Recruiting
University of Chicago Medical Center /ID# 267400	Chicago	Illinois	Recruiting
OSF St. Francis Medical Center /ID# 266973	Peoria	Illinois	Recruiting
Springfield Clinic Main Campus /ID# 267434	Springfield	Illinois	Recruiting
Indiana University Health University Hospital /ID# 278129	Indianapolis	Indiana	Recruiting
University of Kentucky Chandler Medical Center /ID# 265564	Lexington	Kentucky	Recruiting
Metropolitan Gastroenterology Group - Chevy Chase /ID# 265877	Chevy Chase	Maryland	Recruiting
Velocity Clinical Research - Rockville /ID# 267712	Rockville	Maryland	Completed
Lucida Clinical Trials /ID# 266548	New Bedford	Massachusetts	Recruiting
Henry Ford Medical Center - Columbus /ID# 266503	Novi	Michigan	Recruiting
Mayo Clinic-Rochester /ID# 265550	Rochester	Minnesota	Recruiting
GI Associates Research, LLC /ID# 267433	Columbia	Missouri	Recruiting
Bvl Research /ID# 265870	Liberty	Missouri	Recruiting
Washington University /ID# 266938	St Louis	Missouri	Recruiting
Vector Clinical Trials /ID# 265561	Las Vegas	Nevada	Recruiting
Nyu Langone Long Island Clinical Research Associates - Lake Success /ID# 265566	Lake Success	New York	Recruiting
Icahn School of Medicine at Mount Sinai /ID# 266857	New York	New York	Completed
Northwell Health-Lenox Hill Hospital /ID# 265527	New York	New York	Recruiting

+ 215 more sites — see the full list on the official registry below.

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