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A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants With Active Ulcerative Colitis

Active, not recruiting · Phase 2 · NCT06257875

Conditions: Ulcerative Colitis

At a glance

Research payments reported, 2025
$1.3M
U.S. investigators named
49
Sites paid
49
Planned or actual enrollment
156

About the trial

Sponsor
AbbVie
Tested
Lutikizumab (drug), Lutikizumab (drug), Adalimumab (drug)
Dates
Started 2024-03-23; completion 2027-09
Results posted
Not yet

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). The purpose of this study is to assess how safe and effective lutikizumab is in adult participants with moderate to severe UC and how lutikizumab compares to adalimumab in the treatment of UC. Adverse events and changes in disease activity will be assessed. Lutikizumab is an investigational product being developed for the treatment of moderate to severe UC. Participants are placed in groups called treatment arms. Each group receives a different treatment. In the Induction Period, participants will be randomized into 1 of 3 arms re…

From ClinicalTrials.gov, last updated 2025-10-07. Full record, eligibility and contacts (opens in a new tab)

Industry funding

AbbVie Inc. reported $1.3M in research payments for this study in 2025 (282 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

  • Atlantic Medical Research LLC $114,250
  • Univ of Florida Board of Trustees $92,866
  • Dz1lfo Multi Global Conglomerate $80,641
  • Gcp Clinical Research LLC $65,206
  • New York University $58,044
  • Gastroenterology Associates of West $57,834
  • Indiana University $57,400
  • The Johns Hopkins University $51,779
  • Djl Clinical Research PLLC $51,406
  • Erick H Alayo Medical Corporation $48,433
  • University of Kansas Medical Center $48,201
  • Uci Health-Orange, CA $44,993
  • Texas Digestive Disease Cons PLLC $38,849
  • Regents of University of Colorado $37,365
  • Northwestern University $33,167
  • Digestive Disease Specialists Inc $31,377
  • Southern California Research Center $31,056
  • Om Research LLC $29,061
  • Gastroenterology Consultants PC $28,550
  • University of Miami $27,831
  • Wake Forest University $24,105
  • Southern Star Research $22,996
  • Research Associates of S Flo LLC $22,112
  • Mayo Clinic Rochester $20,483
  • Biostar Clinical Group Inc $15,466
  • Gastroenterology Associates Of $15,115
  • Weill Medical College of Cornell Un $15,114
  • University of Florida $12,978
  • Clinical Research Institute Of $11,964
  • Clinical Associates in Research $11,825
  • Ny Scientific Corp $11,549
  • Caribbean Medical Research Center $10,252
  • Adventhealth Orlando, FL $10,136
  • Clinical Research Investigator $9,219
  • Baylor College of Medicine $8,940
  • The Ohio State University $8,828
  • Tyler Research Institute LLC $8,289
  • Newport Huntington Medical Group $7,099
  • University of New Mexico $6,867
  • The University of Chicago $5,090
  • Massachusetts General Hospital, MA $4,543
  • Homestead Associates in Research $4,200
  • Gi Pros $3,698
  • Wisconsin Center for Advanced Resea $3,615
  • Marshall Health (DBA) $2,750
  • Louisiana Research Center LLC $2,603
  • Jd Medical Group LLC $2,300
  • The Trustees of Columbia University $1,485
  • Biostar Clincal Group Inc $1,462

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.