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Studies

Interventional Active not recruiting Phase 2

NCT06598943 on ClinicalTrials.gov

A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis

Official title: An Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Given Alone or in Combination With Mirikizumab for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis

  • Sponsor: Eli Lilly (Group)
  • Enrollment: 143 (Estimated)
  • Study start: 2024-10-10 (Actual)
  • Primary completion: 2026-08-03 (Actual)
  • Study completion: 2027-07-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Double (Participant, Investigator)
  • PrimaryPurpose: Treatment

Brief Summary

The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).

Conditions

  • Ulcerative Colitis
  • Ulcerative Colitis Chronic

Intervention / Treatment

  • Drug: Eltrekibart
  • Drug: Eltrekibart
  • Drug: Mirikizumab
  • Drug: Mirikizumab
  • Drug: Placebo

Primary Outcome Measures

  • Percentage of Participants Achieving Clinical Remission (Week 12)
    Percentage of Participants Achieving Clinical Remission

Countries

Argentina, Belgium, Canada, Colombia, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Latvia, Poland, Romania, Serbia, Spain, Turkey (Türkiye), United States

Locations and Investigators

  • AZ Gastro Care - Chandler, Chandler, United States
  • Applied Research Center of Arkansas, Little Rock, United States
  • Preferred Research Partners, Little Rock, United States
  • Erick Alayo Medical Corp/Gastro SB Clinic, Chula Vista, United States
  • Southern California GI and Liver Centers (SCLC), Coronado, United States
  • Valley View Research, Garden Grove, United States
  • Om Research, LLC, Lancaster, United States
  • United Medical Doctors, Los Alamitos, United States
  • Clinnova Research, Orange, United States
  • Prospective Research Innovations, Rancho Cucamonga, United States
  • Clinical Trials Management Services, LLC, Thousand Oaks, United States
  • Om Research LLC, Victorville, United States
  • Peak Gastroenterology Associates, Colorado Springs, United States
  • Medical Research Center of Connecticut, LLC, Hamden, United States
  • Novum Research, LLC, Clermont, United States
  • I.V.A.M. Clinical & Investigational Center, LLC, Doral, United States
  • Florida Research Institute, Lakewood Rch, United States
  • Well Pharma Medical Research Corp., Miami, United States
  • Reserka, Miami, United States
  • Digestive Disease Consultants DDCJAX, Orange Park, United States
  • Orlando Health Digestive Health Institute, Orlando, United States
  • AdventHealth Orlando, Orlando, United States
  • Nodal Medical Center, Tampa, United States
  • Research Bay,Inc., Tampa, United States
  • GCP Clinical Research, LLC, Tampa, United States
  • International Center for Research LLC, Tampa, United States
  • Northwestern University, Chicago, United States
  • Avicenna Clinical Research - SW Gastroenterology, Oak Lawn, United States
  • Clinical Trials Management, LLC, Metairie, United States
  • Gastroenterology Associates of Western Michigan, P.L.C., Wyoming, United States
  • Ellipsis Research Group, Brooklyn, United States
  • Smart Medical Research - Jackson Heights, Jackson Heights, United States
  • Pioneer Clinical Research NY, New York, United States
  • Digestive Disease Medicine of Central New York, Utica, United States
  • University of North Carolina, Chapel Hill, United States
  • GCGA Physicians, LLC dba / Gastro Health Research, Cincinnati, United States
  • NexGen Research, Lima, United States
  • Inquest Clinical Research, Baytown, United States
  • DHR Health Gastroenterology - Edinburg, Edinburg, United States
  • Baylor College of Medicine, Houston, United States
  • Intergrity Research, Houston, United States
  • Gastroenterology Research of San Antonio, San Antonio, United States
  • Tyler Research Institute, Tyler, United States
  • Care Access-Ogden, Ogden, United States
  • Advanced Research Institute - South Ogden, Ogden, United States
  • University of Washington School Medicine, Seattle, United States
  • CIPREC, CABA, Argentina
  • Mautalen Salud e Investigacion-Centro de Osteopatías Médicas, Ciudad Autonoma de Buenos Air, Argentina
  • Clínica Privada Independencia, Munro, Argentina
  • CER Instituto Medico, Quilmes, Argentina

And 157 other sites.

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) (Study Director) — Eli Lilly and Company