Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease

Part of paid clinical trials in Dothan, Alabama.

Sponsor
AbbVie
Study ID
NCT06548542
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Risankizumab — DRUG
    Subcutaneous Injection
  • Lutikizumab — DRUG
    Subcutaneous Injection
  • Trosunilimab — DRUG
    Intravenous Infusion
  • Risankizumab — DRUG
    Intravenous Infusion
  • Trosunilimab — DRUG
    Subcutaneous Injection
  • ABBV-8736 — DRUG
    Intravenous Infusion

Study Details

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.

Key Dates

Start date
Sep 4, 2024
Status verified
Jun 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
540 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy: Risankizumab
    Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose B as SC injection.
  • 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.
  • Experimental: Monotherapy: Trosunilimab
    Participants will receive trosunilimab Dose A as IV infusion and trosunilimab Dose B as SC injection.
  • 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.
  • Experimental: Monotherapy: Lutikizumab
    Participants will receive Lutikizumab Dose A, Dose B and Dose C as SC injection.
  • Experimental: Monotherapy: ABBV-8736 - OUS Only
    Participants will receive ABBV-8736 as IV infusion.
  • 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.

Primary Outcome Measure

Percentage of Participants who Achieve Endoscopic Remission [ Time Frame: Week 12 ]

Central Contacts

Locations (64)

FacilityCityStateZIPSite coordinators
Digestive Health Specialists /ID# 266216DothanAlabama36301-
East View Medical Research /ID# 270377MobileAlabama36606-
Southern California Res. Ctr /ID# 265549CoronadoCalifornia92118-
UC San Diego Health System /ID# 265565La JollaCalifornia92037-
uc davis medical center - patient support services building /ID# 265554SacramentoCalifornia95817-
Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391San DiegoCalifornia92103-
Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557Colorado SpringsColorado80907-
Danbury Hospital, Western Connecticut Health Network /ID# 265556DanburyConnecticut06810-
Yale University School of Medicine /ID# 266786New HavenConnecticut06510-
Novum Research /ID# 278128ClermontFlorida34711-
University of Florida College of Medicine /ID# 266930GainesvilleFlorida32610-
Nature Coast Clinical Research - Inverness /ID# 265874InvernessFlorida34452-4717-
Atlantic Medical Research /ID# 266207MargateFlorida33063-
A Plus Research /ID# 265878MiamiFlorida33144-
Sanchez Clinical Research /ID# 265887MiamiFlorida33157-
Advanced Research Institute, Inc /ID# 265548New Port RicheyFlorida34653-
Hillcrest Medical Research, LLC /ID# 267237Orange CityFlorida32763-
Endoscopic Research, Inc. /ID# 267211OrlandoFlorida32803-
AdventHealth Medical Group - Tampa - Bruce B Downs Boulevard /ID# 265538TampaFlorida33613-
Gcp Clinical Research /ID# 278126TampaFlorida33609-
Florida Medical Clinic - Zephyrhills /ID# 267392ZephyrhillsFlorida33542-
Gastroenterology Associates of Central Georgia /ID# 265547MaconGeorgia31201
Site Coordinator
478-742-2600
Treasure Valley Medical Research /ID# 267114BoiseIdaho83706-
University of Chicago Medical Center /ID# 267400ChicagoIllinois60637-
OSF St. Francis Medical Center /ID# 266973PeoriaIllinois61637-0001-
Springfield Clinic Main Campus /ID# 267434SpringfieldIllinois62703-2403-
Indiana University Health University Hospital /ID# 278129IndianapolisIndiana46202-
University of Kentucky Chandler Medical Center. /ID# 265564LexingtonKentucky40536-
Metropolitan Gastroenterology Group - Chevy Chase /ID# 265877Chevy ChaseMaryland20815-
Velocity Clinical Research - Rockville /ID# 267712RockvilleMaryland20854-
Lucida Clinical Trials /ID# 266548New BedfordMassachusetts02740-
Henry Ford Medical Center - Columbus /ID# 266503NoviMichigan48377-
Mayo Clinic-Rochester /ID# 265550RochesterMinnesota55905-
GI Associates Research, LLC /ID# 267433ColumbiaMissouri65201-
Bvl Research /ID# 265870LibertyMissouri64068-
Washington University /ID# 266938St LouisMissouri63110-
Vector Clinical Trials /ID# 265561Las VegasNevada89128-
Nyu Langone Long Island Clinical Research Associates - Lake Success /ID# 265566Lake SuccessNew York11042-
Icahn School of Medicine at Mount Sinai /ID# 266857New YorkNew York10029-
Northwell Health-Lenox Hill Hospital /ID# 265527New YorkNew York10075-
Care Access - Yonkers /ID# 266781YonkersNew York10701-
Digestive Health Partners - Biltmore Office /ID# 265539AshevilleNorth Carolina28801-
University of Cincinnati /ID# 265589CincinnatiOhio45267-2827-
The Ohio State University /ID# 265577ColumbusOhio43210-
Digestive Disease Specialists - Oklahoma /ID# 265901Oklahoma CityOklahoma73112-
Penn State Health Milton South Hershey Medical Center /ID# 267126HersheyPennsylvania17033-
University of Pennsylvania /ID# 265904PhiladelphiaPennsylvania19104-
Gastroenterology Associates of Orangeburg /ID# 267548OrangeburgSouth Carolina29118-
GI associates of Northeast Tennessee /ID# 265567Johnson CityTennessee37604-
Gi Alliance - Cedar Park /ID# 268153Cedar ParkTexas78613-
Proactive Clinical Research /ID# 267305El PasoTexas79902-
Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 266935GarlandTexas75044-
Houston Methodist Hospital /ID# 265533HoustonTexas77030-
Caprock Gastro Research - Lubbock - 80th Street /ID# 265541LubbockTexas79424-
GI Alliance: Mansfield /ID# 266947MansfieldTexas76063-
Clinical Associates in Research Therapeutics of America, LLC /ID# 265899San AntonioTexas78212-
Southern Star Research Institute /ID# 278124San AntonioTexas78229-
Sun Research Institute /ID# 266723San AntonioTexas78215-
Texas Digestive Disease Consultants - Southlake /ID# 265576SouthlakeTexas76092-
Tyler Research Institute /ID# 265545TylerTexas75701-
Care Access - Ogden /ID# 266428OgdenUtah84403-
Care Access - Salt Lake City /ID# 266785Salt Lake CityUtah84124-
Virginia Mason Hospital & Medical Center /ID# 265574SeattleWashington98101-
Washington Gastroenterology - Tacoma /ID# 267302TacomaWashington98405-

Find similar trials in Dothan, AL

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Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Digestive Health Specialists· Dothan, ALEast View Medical Research· Mobile, ALSouthern California Res. Ctr· Coronado, CAUC San Diego Health System· La Jolla, CAuc davis medical center - patient support services building· Sacramento, CAClinical Applications Laboratories - San Diego - 3rd Avenue· San Diego, CA

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