Crohn's Disease
Targeted Therapies for Adults With Moderate to Severe Crohn’s Disease
This study is evaluating the effectiveness and adverse events of risankizumab, trosunilimab, lutikizumab, and ABBV-8736 in adults with moderate to severe Crohn’s disease.
Registry title: Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
56 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–75 Years
- Treatment
- Risankizumab or Lutikizumab
- Design
- Randomized
- Central study contact
- ABBVIE CALL CENTER844-663-3742abbvieclinicaltrials@abbvie.com
- Sponsor
- AbbVie
Research question
How effective are the study’s targeted therapies for moderate to severe Crohn’s disease, and what adverse events occur during treatment?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 75 with Crohn’s disease.
- Participants must have had a confirmed Crohn’s disease diagnosis for at least three months, with biopsy documentation available.
- The study is looking for people with active moderate to severe disease based on symptom and endoscopy scores specified by the registry.
- Participants must have been unable to tolerate or had an inadequate response to specified conventional or targeted therapies.
Participation overview
What participation may involve
Participants receive an assigned targeted therapy alone or in a specified combination and attend regular hospital or clinic visits for treatment and assessments. The registry notes that participation may involve more treatment burden than standard care outside the study. What participation may involve: - Receive assigned treatment through infusions into a vein, injections under the skin, or both, depending on the treatment group. - Attend regular study visits at a hospital or clinic. - Undergo medical assessments, blood tests, and endoscopies. - Report side effects and complete questionnaires and a daily diary.
Study interventions
What participants may receive or do
- Risankizumab: Participants in specified treatment groups receive risankizumab as an injection under the skin.
- Lutikizumab: Participants in specified treatment groups receive lutikizumab as an injection under the skin, either alone or with risankizumab.
- Trosunilimab: Participants in specified treatment groups receive trosunilimab by infusion into a vein.
- Risankizumab: Participants in specified treatment groups receive risankizumab by infusion into a vein.
- Trosunilimab: Participants in specified treatment groups receive trosunilimab as an injection under the skin.
- ABBV-8736: Participants in the outside-the-United-States ABBV-8736 group receive the drug by infusion into a vein.
Study design
How the comparison works
This is an open-label, randomized phase 2 platform study. Participants are assigned to an available experimental group receiving one targeted therapy or a specified combination; one long-term extension group is also listed. The registry states that participants are randomized among treatment groups available when they enter the study. The study is open-label, meaning the registry reports no masking. All listed study groups are marked experimental; the registry does not list an active-comparator or usual-care control group.
Reported activities
Procedures and tests
- Endoscopies are used to assess intestinal inflammation and endoscopic remission or response.
- Blood tests are part of the study assessments.
- Medical assessments are used to check treatment effects.
- Participants are monitored for adverse events and other side effects.
- Participants complete questionnaires and a daily diary.
- The Crohn’s Disease Activity Index uses diary entries, interviews, physical examinations, body measurements, and laboratory analysis.
- Screening must confirm the required Crohn’s disease diagnosis documentation, symptom score, and endoscopic inflammation score.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Body weight must be at least 40 kilograms at baseline.
- Crohn’s disease must have been confirmed at least three months before baseline, and biopsy documentation consistent with the diagnosis must be available.
- The Crohn’s Disease Activity Index must be at least 220 at baseline.
- Endoscopy must show mucosal inflammation, with a Simple Endoscopic Score for Crohn’s Disease of at least 6 for ileocolonic or colonic disease, or at least 4 for isolated ileal disease; narrowing is excluded from eligible scores, and a reader determines the score.
- Participants must have been unable to tolerate or had an inadequate response to conventional therapies outside the United States and/or targeted therapies, including biologics or targeted small molecules.
- Participants must be between 18 and 75 years old.
Possible reasons someone may not be able to join
- People who have been unable to tolerate p19 inhibitors, including risankizumab, are excluded.
- An investigational targeted therapy—or a targeted therapy that becomes approved during the study—generally cannot have been received within 30 days or five half-lives before baseline, whichever is longer; the stated exception applies when a commercial assay documents an undetectable or below-quantification drug level for an approved biologic.
- A current diagnosis of ulcerative colitis or indeterminate colitis is excluded.
- A current ostomy or ileoanal pouch is excluded.
- Current short gut or short bowel syndrome is excluded.
- Surgical bowel resection within the three months before baseline is excluded.
Important unknowns
What the record does not make clear
- The registry says visits are regular but does not provide their number, frequency, or expected length.
- The registry reports outcome timeframes up to approximately 96 weeks and a long-term extension lasting up to 72 weeks, but it does not clearly state the duration for each participant or treatment group.
- The registry does not list a placebo group or state a placebo assignment probability.
- The registry does not explain which existing Crohn’s disease medicines may continue during the study.
- The record gives a timing rule for investigational targeted therapies and an exception for certain approved biologics, but does not provide a complete medication-specific washout plan.
- The registry does not state what treatment is available if Crohn’s disease worsens during the study.
- Endoscopies and a week 12 endoscopic outcome are reported, but the total number, timing, preparation, sedation, and biopsy requirements are not specified.
- The registry does not explain which study-related or routine-care costs are paid by the sponsor or billed to insurance.
- The registry does not report whether participants receive compensation or expense reimbursement.
- The registry does not report whether transportation, lodging, or other travel support is available.
- The registry says regular visits occur at a hospital or clinic but does not state whether any visits or diary activities can be completed remotely.
- The registry does not describe access to assigned treatment after study participation ends.
- The overall study is recruiting and many locations are listed, but treatment-group and site availability can vary.
Before contacting the site
Questions for the study team
- Which treatment groups are currently available at this site, and how would random assignment work among them?
- What is the complete visit schedule, including infusion or injection visits, endoscopies, blood tests, and follow-up?
- How long would participation last in the currently available group, and is the long-term extension optional?
- Which current medicines may continue, and what medication-specific washout rules would apply before baseline?
- What happens if Crohn’s disease worsens, including what rescue treatments are allowed and when study treatment would stop?
- Which study-related costs are covered, and are compensation, travel reimbursement, or remote options available?
Before changing care
Questions for your gastroenterologist
- How might the study’s medication and washout requirements affect the continuity of my current Crohn’s disease treatment?
- How stable is my Crohn’s disease now, and what concerns would you have about the study’s treatment groups, infusions, injections, and endoscopies in my clinical context?
- What approved treatment alternatives should I understand before deciding whether to contact the study team?
- If I explore this study, how should you and the research team coordinate medication changes, disease monitoring, endoscopy results, and care if symptoms worsen?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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 design and administration
- Organization
- AbbVie
- Organization class
- Industry
- Organization study ID
- M24-885
- Lead sponsor
- AbbVie
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Sequential
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Monotherapy: Risankizumab
Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose B as SC injection.
Interventions: Drug: Risankizumab
Experimental
Combination Therapy: Risankizumab and Trosunilimab
Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and trosunilimab Dose A as IV infusion and trosunilimab Dose B as SC injection.
Interventions: Drug: Risankizumab, Drug: Trosunilimab
Experimental
Monotherapy: Trosunilimab
Participants will receive trosunilimab Dose A as IV infusion and trosunilimab Dose B as SC injection.
Interventions: Drug: Trosunilimab
Experimental
Combination Therapy: Risankizumab and Lutikizumab
Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and Lutikizumab Dose A, Dose B and Dose C as SC injection.
Interventions: Drug: Risankizumab, Drug: Lutikizumab
Experimental
Monotherapy: Lutikizumab
Participants will receive Lutikizumab Dose A, Dose B and Dose C as SC injection.
Interventions: Drug: Lutikizumab
Experimental
Monotherapy: ABBV-8736 - OUS Only
Participants will receive ABBV-8736 as IV infusion.
Interventions: Drug: ABBV-8736
Experimental
Long-Term Extension: Risankizumab Monotherapy
Participants will receive Risankizumab Dose A as IV infusion and/or Risankizumab Dose B as SC injection for up to 72 weeks.
Interventions: Drug: Risankizumab
Interventions
Drug
Risankizumab
Subcutaneous Injection
Drug
Lutikizumab
Subcutaneous Injection
Drug
Trosunilimab
Intravenous Infusion
Drug
Risankizumab
Intravenous Infusion
Drug
Trosunilimab
Subcutaneous Injection
Drug
ABBV-8736
Intravenous Infusion
Eligibility
18 Years–75 Years
All
Not accepted
Inclusion criteria (5)
- Participants' body weight must be \>= 40 kg at Baseline.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- CDAI \>= 220 at Baseline.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and/or TaTs. TaTs include biologics and/or targeted small molecules.Registry-derived · unreviewed
Exclusion criteria (3)
- Participant who demonstrated intolerance to p19 inhibitors, including risankizumab.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Percentage of Participants who Achieve Endoscopic Remission
Time frame: 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.
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: 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.
Secondary outcome
Percentage of Participants who Achieve Endoscopic Response
Time frame: 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.
Secondary outcome
Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS)
Time frame: 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.
Secondary outcome
Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI)
Time frame: 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
Recruiting locations in the United States
Digestive Health Specialists /ID# 266216
RecruitingDothan, Alabama, 36301, United States
East View Medical Research /ID# 270377
RecruitingMobile, Alabama, 36606, United States
Southern California Res. Ctr /ID# 265549
RecruitingCoronado, California, 92118, United States
UC San Diego Health System /ID# 265565
RecruitingLa Jolla, California, 92037, United States
uc davis medical center - patient support services building /ID# 265554
RecruitingSacramento, California, 95817, United States
Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391
RecruitingSan Diego, California, 92103, United States
Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557
RecruitingColorado Springs, Colorado, 80907, United States
Danbury Hospital, Western Connecticut Health Network /ID# 265556
RecruitingDanbury, Connecticut, 06810, United States
Yale University School of Medicine /ID# 266786
RecruitingNew Haven, Connecticut, 06510, United States
Novum Research /ID# 278128
RecruitingClermont, Florida, 34711, United States
University of Florida College of Medicine /ID# 266930
RecruitingGainesville, Florida, 32610, United States
Nature Coast Clinical Research - Inverness /ID# 265874
RecruitingInverness, Florida, 34452-4717, United States
Atlantic Medical Research /ID# 266207
RecruitingMargate, Florida, 33063, United States
A Plus Research /ID# 265878
RecruitingMiami, Florida, 33144, United States
Sanchez Clinical Research /ID# 265887
RecruitingMiami, Florida, 33157, United States
Advanced Research Institute, Inc /ID# 265548
RecruitingNew Port Richey, Florida, 34653, United States
Hillcrest Medical Research, LLC /ID# 267237
RecruitingOrange City, Florida, 32763, United States
Endoscopic Research, Inc. /ID# 267211
RecruitingOrlando, Florida, 32803, United States
AdventHealth Medical Group - Tampa - Bruce B Downs Boulevard /ID# 265538
RecruitingTampa, Florida, 33613, United States
Gcp Clinical Research /ID# 278126
RecruitingTampa, Florida, 33609, United States
Florida Medical Clinic - Zephyrhills /ID# 267392
RecruitingZephyrhills, Florida, 33542, United States
Gastroenterology Associates of Central Georgia /ID# 265547
RecruitingMacon, Georgia, 31201, United States
Site Coordinator478-742-2600
Treasure Valley Medical Research /ID# 267114
RecruitingBoise, Idaho, 83706, United States
University of Chicago Medical Center /ID# 267400
RecruitingChicago, Illinois, 60637, United States
OSF St. Francis Medical Center /ID# 266973
RecruitingPeoria, Illinois, 61637-0001, United States
Springfield Clinic Main Campus /ID# 267434
RecruitingSpringfield, Illinois, 62703-2403, United States
Indiana University Health University Hospital /ID# 278129
RecruitingIndianapolis, Indiana, 46202, United States
University of Kentucky Chandler Medical Center /ID# 265564
RecruitingLexington, Kentucky, 40536, United States
Metropolitan Gastroenterology Group - Chevy Chase /ID# 265877
RecruitingChevy Chase, Maryland, 20815, United States
Lucida Clinical Trials /ID# 266548
RecruitingNew Bedford, Massachusetts, 02740, United States
Henry Ford Medical Center - Columbus /ID# 266503
RecruitingNovi, Michigan, 48377, United States
Mayo Clinic-Rochester /ID# 265550
RecruitingRochester, Minnesota, 55905, United States
GI Associates Research, LLC /ID# 267433
RecruitingColumbia, Missouri, 65201, United States
Bvl Research /ID# 265870
RecruitingLiberty, Missouri, 64068, United States
Washington University /ID# 266938
RecruitingSt Louis, Missouri, 63110, United States
Vector Clinical Trials /ID# 265561
RecruitingLas Vegas, Nevada, 89128, United States
Nyu Langone Long Island Clinical Research Associates - Lake Success /ID# 265566
RecruitingLake Success, New York, 11042, United States
Northwell Health-Lenox Hill Hospital /ID# 265527
RecruitingNew York, New York, 10075, United States
Care Access - Yonkers /ID# 266781
RecruitingYonkers, New York, 10701, United States
Digestive Health Partners - Biltmore Office /ID# 265539
RecruitingAsheville, North Carolina, 28801, United States
University of Cincinnati /ID# 265589
RecruitingCincinnati, Ohio, 45267-2827, United States
The Ohio State University /ID# 265577
RecruitingColumbus, Ohio, 43210, United States
Digestive Disease Specialists - Oklahoma /ID# 265901
RecruitingOklahoma City, Oklahoma, 73112, United States
University of Pennsylvania /ID# 265904
RecruitingPhiladelphia, Pennsylvania, 19104, United States
Gastroenterology Associates of Orangeburg /ID# 267548
RecruitingOrangeburg, South Carolina, 29118, United States
GI associates of Northeast Tennessee /ID# 265567
RecruitingJohnson City, Tennessee, 37604, United States
Gi Alliance - Cedar Park /ID# 268153
RecruitingCedar Park, Texas, 78613, United States
Houston Methodist Hospital /ID# 265533
RecruitingHouston, Texas, 77030, United States
Caprock Gastro Research - Lubbock /ID# 265541
RecruitingLubbock, Texas, 79424, United States
GI Alliance - Mansfield /ID# 266947
RecruitingMansfield, Texas, 76063, United States
Southern Star Research Institute /ID# 278124
RecruitingSan Antonio, Texas, 78229, United States
Sun Research Institute /ID# 266723
RecruitingSan Antonio, Texas, 78215, United States
Tyler Research Institute /ID# 265545
RecruitingTyler, Texas, 75701, United States
Care Access - Ogden /ID# 266428
RecruitingOgden, Utah, 84403, United States
Virginia Mason Hospital and Medical Center /ID# 265574
RecruitingSeattle, Washington, 98101, United States
Washington Gastroenterology - Tacoma /ID# 267302
RecruitingTacoma, Washington, 98405, United States
This study also lists 191 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Aug 12, 2024
- Primary completion
- Jan 2030
- Overall completion
- Jan 2030
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.