Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
- 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.
- Acronym
- Target CD
- Short title
- Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
- Official title
- A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2030-01-01
- First posted
- 2024-08-12
- Registry last updated
- 2026-06-26
- Primary completion date
- 2030-01-01
- Start date
- 2024-09-04
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- AbbVie
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06548542
- ClinicalTrials.gov ID
- NCT06548542
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- No masking
Percentage of Participants who Achieve Endoscopic Remission
Timeframe: 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)
Timeframe: 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.
Percentage of Participants who Achieve Endoscopic Response
Timeframe: Week 12
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.
Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS)
Timeframe: Week 12
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.
Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI)
Timeframe: Week 12
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
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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.
- 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.
- Digestive Health Specialists /ID# 266216Dothan, United StatesRecruiting
- East View Medical Research /ID# 270377Mobile, United StatesRecruiting
- Southern California Res. Ctr /ID# 265549Coronado, United StatesRecruiting
- UC San Diego Health System /ID# 265565La Jolla, United StatesRecruiting
- uc davis medical center - patient support services building /ID# 265554Sacramento, United StatesRecruiting
- Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391San Diego, United StatesRecruiting
- Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557Colorado Springs, United StatesRecruiting
- Danbury Hospital, Western Connecticut Health Network /ID# 265556Danbury, United StatesRecruiting
- Yale University School of Medicine /ID# 266786New Haven, United StatesRecruiting
- Novum Research /ID# 278128Clermont, United StatesRecruiting
- University of Florida College of Medicine /ID# 266930Gainesville, United StatesRecruiting
- Nature Coast Clinical Research - Inverness /ID# 265874Inverness, United StatesRecruiting
- Atlantic Medical Research /ID# 266207Margate, United StatesRecruiting
- A Plus Research /ID# 265878Miami, United StatesRecruiting
- Sanchez Clinical Research /ID# 265887Miami, United StatesRecruiting
- Advanced Research Institute, Inc /ID# 265548New Port Richey, United StatesRecruiting
- Hillcrest Medical Research, LLC /ID# 267237Orange City, United StatesRecruiting
- Endoscopic Research, Inc. /ID# 267211Orlando, United StatesRecruiting
- Gcp Clinical Research /ID# 278126Tampa, United StatesRecruiting
- AdventHealth Medical Group - Tampa - Bruce B Downs Boulevard /ID# 265538Tampa, United StatesRecruiting
- Florida Medical Clinic - Zephyrhills /ID# 267392Zephyrhills, United StatesRecruiting
- Gastroenterology Associates of Central Georgia /ID# 265547Macon, United StatesRecruiting
- Treasure Valley Medical Research /ID# 267114Boise, United StatesRecruiting
- University of Chicago Medical Center /ID# 267400Chicago, United StatesRecruiting
- OSF St. Francis Medical Center /ID# 266973Peoria, United StatesRecruiting
And 230 more, listed on the interactive page.
Other registry identifiers
- 2024-513009-30-00
Related records
Drugs (3)
Lead sponsors (1)
Conditions (1)
- Crohn disease Primary condition